Insomnia Disorders
Conditions
Brief summary
The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.
Interventions
DRUGZolpidem
Zolpidem will be administered as 5 mg or 10 mg (2\*5mg capsule) oral capsule once daily based upon the local labeling information.
DRUGPlacebo
Matching placebo will be administered once daily based upon dosing group.
JNJ-42847922 will be administered as 5 mg (2\*2.5 mg capsule) oral capsules once daily.
DRUGJNJ-42847922, 10 mg
JNJ-42847922 will be administered as 10 mg oral capsule once daily.
JNJ-42847922 will be administered as 20 mg oral capsule once daily.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Participant must be a man or women of non-childbearing potential (WONCBP), 18 to 85 years of age, inclusive, on the day of signing informed consent. A WONCBP is defined as: a).Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. b). Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. c). If reproductive status is questionable, additional evaluation should be considered * Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder * Participant must have an Insomnia Severity Index (ISI) total score greater than or equal to (\>=) 15 at screening * Participant must have an self-reported sleep onset latency (sSOL) \>=45 minutes and a subjective wake after sleep onset (sWASO) \>= 60 minutes on at least 3 nights over any 7-day period during Part 1 of screening, using the Consensus Sleep Diary - Morning Administration (CSD-M), prior to screening polysomnography (PSG) assessments * Participant must demonstrate a 2-night mean latency to persistent sleep (LPS) of \>= 25 minutes (with neither night less than \[\<\] 20 minutes), a 2 night mean wake after sleep onset (WASO) \>= 30 minutes, and a 2 night mean total sleep time (TST) less than or equal to (=\<) 6.5 hours, with neither night greater than (\>) 7 hours * Participant must be otherwise healthy or present with stable, well-controlled, chronic conditions on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening
Exclusion criteria
* Has history of or current clinically significant and/or unstable liver (moderate or severe hepatic impairment \[Child-Pugh Score {\>=} 7\]) or renal insufficiency (severe renal impairment \[estimated creatinine clearance below 30 {milliliter per minute} mL/min\]; serum creatinine \>2 \[milligram per deciliter\] mg/dL); significant and/or unstable cardiac, vascular, pulmonary (example, acute or severe respiratory failure), gastrointestinal, endocrine, neurologic (example, myasthenia gravis, narcolepsy), hematologic, rheumatologic, immunologic, or metabolic disturbances. Organic brain disease, epilepsy, dementia, narcolepsy, narrow angle glaucoma and known or suspected mental retardation are exclusionary. Any clinically relevant medical condition that is likely to result in deterioration of the participant's condition or affect the participant's safety during the study (eg, medically frail participant with history of hospitalization due to fractures) or could potentially alter the absorption, metabolism, or excretion of the study drug is exclusionary * Has uncontrolled hypertension (supine systolic blood pressure \>150 millimeter of mercury (mm Hg) in adult participants or \>160 mm Hg in elderly participants or supine diastolic blood pressure \>90 mm Hg, despite diet, exercise, or a stable dose of allowed antihypertensive therapy) at screening or Day 1. (A participant with hypertension may be included if the participant's hypertension has been controlled for at least 3 months prior to screening, and the dosage of any antihypertensive medication has been stable for the past 3 months) * Has clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. Participants with non-insulin dependent diabetes mellitus who are adequately controlled (hemoglobin A1c \[HbA1c\] =\< 8 percent \[%\]) may be eligible to participate if otherwise medically healthy. It is expected that laboratory values will generally be within the normal range, though minor deviations, which are not considered to be of clinical significance to both the investigator and the sponsor's Safety Physician, are acceptable * Has clinically significant ECG abnormalities at screening or Day 1 prior to randomization defined as: 1. QT interval corrected according to Fridericia's formula: \>= 450 millisecond (msec) (males); \>= 470 msec (females). 2. Evidence of 2nd and 3rd degree atrioventricular block, or 1st degree atrioventricular block with PR interval \>210 msec, left bundle branch block. 3. Features of new ischemia. 4. Other clinically important arrhythmia * Has significant hypersomnia not related to night time insomnia (based on clinical judgment of the investigator) * Regularly naps more than 3 times per week * Has a current diagnosis or recent history of psychotic disorder, major depressive disorder (MDD), bipolar disorder, or posttraumatic stress disorder, or other psychiatric condition that, in the investigator's opinion, would interfere with the participant's ability to participate in the trial * Has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or Day 1. Participants with a prior suicide attempt of any sort, or prior serious suicidal ideation/plan within the past 6 months, should be carefully screened for current suicidal ideation and only participants with non-serious items (1-3 of the suicidal ideation section of the C-SSRS) may be included at the discretion of the investigator * Has insomnia related to restless leg syndrome (RLS) (defined as periodic leg movement \[PLM\]-arousal index of \>=10 PLM-related electroencephalograph (EEG) arousals per hour of sleep for adult participants or \>15 for elderly participants), sleep breathing disorder (defined as an apnea hypopnea index \>=10 cumulative apneas and hypopneas per hour of EEG sleep for adult participants or \>15 for elderly participants), or parasomnias. These disorders will be ruled out by the first PSG recording during Part 2 of screening * Has known allergies, hypersensitivity, intolerance, lack of response, or any contraindication to JNJ-42847922 or zolpidem or their excipients * Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug; and/or, Is pregnant, or breastfeeding, while enrolled in this study or within 1 month after the last dose of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | Baseline and Night 1 | Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in LPS as Measured by PSG on Night 13 | Baseline and Night 13 | LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. Negative changes in LPS indicate improvement. |
| Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | Baseline and over first 6 hours on Night 13 | PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 13. Negative changes in WASO indicate improvement. |
| Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Baseline, Over 6 hours on Nights 1 and 13 | TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. |
| Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Baseline, Over 8 hours on Nights 1 and 13 | TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. |
| Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Baseline, Nights 1 and 13 | Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percentage). Positive changes in SE indicate improvement. |
| Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | Baseline, Days 1 and 13 (Hours 1 to 8) | Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement. |
| Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Baseline, Over 6 hours on Day 1 and 13 | PSG was used to measure the number of night-time awakenings over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement. |
| Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement. |
| Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement. |
| Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure number of night time awakenings per hour. Negative changes in nNAW/hr indicate improvement. |
| Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement. |
| Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure REM duration (time to first REM period from sleep onset). |
| Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the REM latency. REM latency was defined as the time to first REM from sleep onset to reaching the first epoch of REM sleep. |
| Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 and 13 | PSG was used to measure the sleep-onset REM in participants. REM sleep periods within 15 minutes from sleep onset were measured. |
| Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure the number of sleep cycles. |
| Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Baseline, Day 1 and 13 | PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Total time spent was sum of N1, N2 and N3. Positive changes in NREM duration indicate improvement. |
| Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | Baseline, Days 2 and 14 | CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement. |
| Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | Baseline, Days 2 and 14 | The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality (sQUAL) and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement. |
| Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Baseline, Days 2 and 14 | CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. CSD-M parameters analyzed include: s-nNAW. Negative change in s-nNAW indicate improvement. |
| Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Baseline, Days 8 and 14 | PROMIS Sleep Disturbance (PROMIS-SD) Short Form subscale consists of a static 8-item questionnaire. Using a recall period of the past 7 days, it assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Each question has 5 response options ranging in value from 1 to 5. To find the total raw score for a short form with all questions answered, sum the values of the response to each question and a total score ranges from 8 to 40. Lower scores indicate less sleep disturbance. Negative changes in scores indicate improvement. |
| Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Baseline, Days 8 and 14 | PROMIS-Sleep Related Impairment (PROMIS-SRI) scale consists of 8 items to evaluate daytime consequences of functioning 5-point Likert scale ranging from 1 to 5. PROMIS-SRI measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question has five response options ranging in value from 1 to 5. To find total raw score (which range from 8 to 40) with all questions answered, sum values of response to each question. Higher score indicates greater sleep impairment. |
| Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14 | Baseline and Day 14 | The PGI-S is a self-reported scale to measure severity of illness using a 6-point scale ranging from 1 to 6, (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, participants rated their severity on the PGI-S scale. Negative changes in scores indicate improvement. |
| Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14 | Baseline and Day 14 | PGI-I is a self-reported scale to measure improvement in illness using a 7-point scale ranging from 1 to 7, (1=very much improved, 2=much improved, 3=improved \[just enough to make a difference\], 4=no change, 5=worse \[just enough to make a difference\], 6=much worse, 7=very much worse). Negative changes in scores indicate improvement. |
| Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | Day 14 | Percentage of participants who achieved at least 50% reduction from baseline in ISI total score (responders) were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, Scores are summed for a total score which ranges from 0-28. Negative changes in scores indicate improvement. ISI total score is the sum of all item scores. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28). |
| Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | Day 14 | Percentage of participants with remission of insomnia symptom defined as, total score of \<= 10 on ISI scale. ISI is 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. 5-point Likert scale (0-4) is used to rate each item. ISI total score is the sum of all item scores. ISI total score is the sum of all item scores. Scores are summed for a total score which ranges from 0-28 and interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28). |
| Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14 | Baseline and Day 14 | The CGI-S is a 7-point scale to measure severity of illness (1=normal \[not at all ill\], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants). Higher score indicates more severity. Negative changes in scores indicate improvement. |
| Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14 | Baseline and Day 14 | The CGI-I is a 7-point scale to measure improvement in illness using a 7-point scale ranging from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity. Negative changes in scores indicate improvement. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Day 17 | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent adverse events are adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date. |
| Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Up to Day 17 | Treatment-emergent serious adverse events are serious adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date. Events of special interest included: Cataplexy; Sleep paralysis; Complex sleep-related behaviors such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); Abnormal dreams; Falls. |
| Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Up to Day 15 | Clinically significant vital signs (pulse, supine and standing blood pressure (systolic and diastolic), and oral, temperature) and physical abnormalities (body weight) were reported. Abnormally low parameters included pulse (bpm)- decrease value from baseline greater than or equal to (\>=) 15 to \<=50; Systolic BP (mmHg \[Millimeter of mercury\])- decrease value from baseline \>=20 to \<=90; Diastolic BP- decrease value from baseline \>=15 to \<=50; weight (Kilogram\[Kg\])- decrease from baseline \>=7%; Body temperature (Celsius \[C\])- \<35.5. Abnormally high parameters included pulse- increase value from baseline \>=15 to \>=100; Systolic BP(mmHg)- increase from baseline of \>=20 to \>=180; Diastolic BP- increase value from baseline \>=15 to \>=105; weight(Kg)- increase from baseline of \>=7%; body temperature (C)- \>37.5. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Up to Day 14 | Twelve-lead ECGs were recorded in a supine position and different ECG intervals (Respiratory rate \[RR\], PR, time for ventricular depolarization \[QRS\], and total time from ventricular depolarization to complete repolarization \[QT\]) and heart rate was measured. This included heart rate:\<=50 beats per minute (bpm) and \>=100 bpm; PR interval \<=120 millisecond (msec) and \>=200 msec; QRS interval: \<=60 msec and \>=120 msec; QT interval:\<=200 msec and \>=500 msec. |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Up to Day 15 | Number of participants with clinically significant laboratory abnormalities were reported. Blood samples for serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, chloride, creatine Kinase, gamma glutamyl transferase, lactate dehydrogenase, phosphate, potassium, sodium), and urinalysis (bilirubin, protein) were collected for clinical laboratory testing. |
| Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Day 14 | C-SSRS is a questionnaire designed to solicit occurrence, severity, frequency of suicidal ideation/behaviors using following scores: Suicidal Ideation-1:Wish to be Dead; 2:Non-specific Active Suicidal Thoughts; 3:Active Suicidal Ideation with Any Methods without Intent to Act; 4:Active Suicidal Ideation with Some Intent to Act; 5:Active Suicidal Ideation with Specific Plan/Intent; Suicidal Behavior-6:Preparatory Acts; 7:Aborted Attempt; 8:Interrupted Attempt; 9:Actual Attempt; 10:Completed Suicide. If no events qualify for score of 1-10, score 0 indicate no event that can be assessed on basis of C-SSRS. Higher scores= greater severity. |
| Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Baseline, Days 2 and 14 | The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a single item assessed on 9-point Likert scale with response options from: 1=very alert to 9=very sleepy (fighting sleep). Negative changes indicate improvement. |
| Postural Stability Measured by Ataxiameter | Day 14 (morning) | The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway was measured using an ataxiameter. Participants were instructed to wear a pair of thin socks for each session. Before starting a measurement, participants were asked to stand still and comfortable, with their feet approximately 10 centimeters (cm) apart and their hands in a relaxed position alongside the body and eyes closed. The total period of body sway measurement was 2 minutes. |
| Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | Baseline and Day 14 (Morning) | Power of Attention is a combination of the speed scores from the three tests of attention, and is established to reflect the ability to focus attention and to process information. Power of Attention was calculated from the sum of the reaction time measured from the attentional tasks (Simple Reaction Time, Choice Reaction Time and Digit Vigilance Speed). Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration. |
| Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | Baseline and Day 14 (Morning) | Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. |
| Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | Baseline and Day 14 (Morning) | Quality of working memory is a combination of the scores from Spatial Working Memory and Numeric Working Memory tasks, and is established to reflect the ability to temporarily hold numeric and spatial information in memory. Sum of Spatial and Numeric Working Memory sensitivity indices (SI) (accuracy) was used to calculate the quality of working memory. The quality of working memory score was calculated from formulae that combined the accuracy scores for the original as well as the new (distractor) stimuli. The range for both the numeric working memory and spatial working memory tasks SI are -1 to 1. Smaller scores reflect poorer ability (poorer quality of working memory),larger scores reflect better ability (better quality of working memory). Total score is the sum of Spatial Working Memory and Numeric Working Memory (ranges from -2 to 2). Smaller scores reflect poorer ability (poorer quality of working memory), larger scores reflect better ability (better quality of working memory. |
| Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | Baseline and Day 14 (Morning) | Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (that is an event or a name) and a negative change from baseline reflects impairment compared to baseline. |
| Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | Baseline and Day 14 (Morning) | The sum of the speed measures from the two working memory tasks (Spatial and Numeric) and the two recognition tasks (Word and Picture). Speed of Memory combines reaction times from Spatial Working Memory (range:150 to 30000 millisecond \[ms\]), Numeric Working Memory (150 to 30000 ms), Word Recognition (250 to 30000 ms) and Picture recognition (250 to 30000 ms) tasks. The total reaction time (sum of above 4 reaction times) measures memory retrieval speed which ranges from 800 to 120000 ms. Slower reaction time reflect poorer ability and faster reaction time reflect better ability. |
| Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | Baseline and over first 6 hours on Night 1 | PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 1. Negative changes in WASO indicate improvement. |
| Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | Day 14 to Day 17 | CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality (sQUAL) and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement. |
| Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) | Day 14 to Day 17 | CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: s-nNAW. Negative change in s-nNAW indicate improvement. |
| Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Day 14 to Day 17 | PWC-20 is a reliable, sensitive instrument having 20-items used to assess potential withdrawal symptoms following cessation of treatment. Items are as follows: Loss of Appetite, Nausea-Vomiting, Diarrhea, Anxiety-Nervousness, Irritability, Dysphoric Mood-Depression, Insomnia, Fatigue, Poor Coordination, Restlessness, Diaphoresis, Tremor, Dizziness, Headaches, Stiffness, Weakness, Increased Acuity Sound Smell Touch (IASST), Paresthesias, Remember, Derealization. Each item score ranges from 0 (not present)-3 (severe), where higher scores = more affected condition. Total score ranges from 0-60, where higher score indicates more affected condition. PWC-20 score was imputed as follows: sum of the non-missing items \* (total number of items) / (number of items non-missing). |
| Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 | Day 17 | The BWSQ is a 20 symptom self-reported questionnaire to investigate withdrawal symptoms. Total score is the sum of item scores. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. Participants rated the degree to which they were experiencing each symptom as either 0=No, 1=Yes-moderate or 2=Yes-severe. The questionnaire had been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms. |
| Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | Day 14 to Day 17 | CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. Negative change in sSOL, sWASO indicate improvement and positive change in Subjective Total Sleep Time (sTST) indicates improvement. |
Countries
Belgium, France, Germany, Japan, Poland, United States
Participant flow
Pre-assignment details
Total of 365 participants were randomized and 364 participants were treated. 1 participant was randomized in error, never received any study drug and was excluded from the analyses. Among 364 treated participants,1 participant randomized to JNJ-42847922 10 mg group, received 5 mg of JNJ-42847922 and was summarized under 5 mg group for safety analyses, and under 10 mg dose group for all other analyses.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14. | 75 |
| JNJ-42847922 5 mg Participants received JNJ-42847922 5 milligrams (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | 71 |
| JNJ-42847922 10 mg Participants received JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | 74 |
| JNJ-42847922 20 mg Participants received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. | 71 |
| Zolpidem Participants received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. | 73 |
| Total | 364 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 0 | 2 | 2 |
| Overall Study | Non-compliance with study drug | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Randomized, not treated. | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | Placebo | JNJ-42847922 5 mg | JNJ-42847922 10 mg | JNJ-42847922 20 mg | Zolpidem |
|---|---|---|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 12.4 | 58.6 years STANDARD_DEVIATION 11.49 | 56.9 years STANDARD_DEVIATION 13.85 | 57.6 years STANDARD_DEVIATION 12.9 | 57.6 years STANDARD_DEVIATION 11.88 | 58.5 years STANDARD_DEVIATION 12.03 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adults (18-64 years) | 238 Participants | 50 Participants | 45 Participants | 48 Participants | 47 Participants | 48 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65 to 84 years | 126 Participants | 25 Participants | 26 Participants | 26 Participants | 24 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants | 13 Participants | 13 Participants | 10 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 310 Participants | 62 Participants | 58 Participants | 63 Participants | 64 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 30 Participants | 8 Participants | 5 Participants | 7 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 73 Participants | 11 Participants | 15 Participants | 20 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 251 Participants | 54 Participants | 49 Participants | 46 Participants | 45 Participants | 57 Participants |
| Sex: Female, Male Female | 246 Participants | 45 Participants | 48 Participants | 51 Participants | 50 Participants | 52 Participants |
| Sex: Female, Male Male | 118 Participants | 30 Participants | 23 Participants | 23 Participants | 21 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 72 | 0 / 73 | 0 / 71 | 0 / 73 |
| other Total, other adverse events | 22 / 75 | 16 / 72 | 10 / 73 | 13 / 71 | 21 / 73 |
| serious Total, serious adverse events | 0 / 75 | 0 / 72 | 0 / 73 | 1 / 71 | 1 / 73 |
Outcome results
Primary
Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1
Change in LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement.
Time frame: Baseline and Night 1
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | -15.24 Minutes | Standard Deviation 78.547 |
| JNJ-42847922 5 mg | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | -29.92 Minutes | Standard Deviation 49.049 |
| JNJ-42847922 10 mg | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | -49.49 Minutes | Standard Deviation 53.216 |
| JNJ-42847922 20 mg | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | -47.69 Minutes | Standard Deviation 48.423 |
| Zolpidem | Change From Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1 | -40.74 Minutes | Standard Deviation 54.395 |
p-value: =0.34690% CI: [0.7, 1.1]ANCOVA
p-value: =0.00190% CI: [0.51, 0.81]ANCOVA
p-value: <0.00190% CI: [0.41, 0.64]ANCOVA
p-value: 0MCP-mod
Secondary
Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17
The BWSQ is a 20 symptom self-reported questionnaire to investigate withdrawal symptoms. Total score is the sum of item scores. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. Participants rated the degree to which they were experiencing each symptom as either 0=No, 1=Yes-moderate or 2=Yes-severe. The questionnaire had been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms.
Time frame: Day 17
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participant analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 | 1.5 Units on a Scale | Standard Deviation 2.58 |
| JNJ-42847922 5 mg | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 | 1.2 Units on a Scale | Standard Deviation 1.9 |
| JNJ-42847922 10 mg | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 | 2.0 Units on a Scale | Standard Deviation 3.44 |
| JNJ-42847922 20 mg | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 | 1.5 Units on a Scale | Standard Deviation 2.93 |
| Zolpidem | Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17 | 2.0 Units on a Scale | Standard Deviation 3.1 |
Secondary
Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14
The CGI-I is a 7-point scale to measure improvement in illness using a 7-point scale ranging from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity. Negative changes in scores indicate improvement.
Time frame: Baseline and Day 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14 | 3.0 Units on a Scale |
| JNJ-42847922 5 mg | Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14 | 3.0 Units on a Scale |
| JNJ-42847922 10 mg | Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14 | 3.0 Units on a Scale |
| JNJ-42847922 20 mg | Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14 | 3.0 Units on a Scale |
| Zolpidem | Change From Baseline in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Score on Day 14 | 2.0 Units on a Scale |
Secondary
Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14
The CGI-S is a 7-point scale to measure severity of illness (1=normal \[not at all ill\], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants). Higher score indicates more severity. Negative changes in scores indicate improvement.
Time frame: Baseline and Day 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14 | 0.0 Units on a scale |
| JNJ-42847922 5 mg | Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14 | -1.0 Units on a scale |
| JNJ-42847922 10 mg | Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14 | -1.0 Units on a scale |
| JNJ-42847922 20 mg | Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14 | -1.0 Units on a scale |
| Zolpidem | Change From Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Score on Day 14 | -1.0 Units on a scale |
Secondary
Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.
Time frame: Baseline and Day 14 (Morning)
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 0.36 units on a scale | Standard Deviation 5.31 |
| JNJ-42847922 5 mg | Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -0.20 units on a scale | Standard Deviation 3.16 |
| JNJ-42847922 10 mg | Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -1.37 units on a scale | Standard Deviation 6.35 |
| JNJ-42847922 20 mg | Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 0.10 units on a scale | Standard Deviation 5.05 |
| Zolpidem | Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -0.39 units on a scale | Standard Deviation 5.14 |
Secondary
Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14
PROMIS-Sleep Related Impairment (PROMIS-SRI) scale consists of 8 items to evaluate daytime consequences of functioning 5-point Likert scale ranging from 1 to 5. PROMIS-SRI measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question has five response options ranging in value from 1 to 5. To find total raw score (which range from 8 to 40) with all questions answered, sum values of response to each question. Higher score indicates greater sleep impairment.
Time frame: Baseline, Days 8 and 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 8 | -4.0 Units on a Scale | Standard Deviation 6.56 |
| Placebo | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 14 | -5.2 Units on a Scale | Standard Deviation 6.88 |
| JNJ-42847922 5 mg | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 8 | -7.0 Units on a Scale | Standard Deviation 6.15 |
| JNJ-42847922 5 mg | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 14 | -9.1 Units on a Scale | Standard Deviation 6.53 |
| JNJ-42847922 10 mg | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 8 | -5.5 Units on a Scale | Standard Deviation 6.55 |
| JNJ-42847922 10 mg | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 14 | -6.3 Units on a Scale | Standard Deviation 6.94 |
| JNJ-42847922 20 mg | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 14 | -7.8 Units on a Scale | Standard Deviation 6.98 |
| JNJ-42847922 20 mg | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 8 | -8.8 Units on a Scale | Standard Deviation 7.09 |
| Zolpidem | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 8 | -4.9 Units on a Scale | Standard Deviation 6.98 |
| Zolpidem | Change From Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System - Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14 | Day 14 | -7.4 Units on a Scale | Standard Deviation 6.35 |
Secondary
Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14
The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a single item assessed on 9-point Likert scale with response options from: 1=very alert to 9=very sleepy (fighting sleep). Negative changes indicate improvement.
Time frame: Baseline, Days 2 and 14
Population: Analysis population was SAS. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 2 | 0.3 Units on a Scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 14 | 0.1 Units on a Scale | Standard Deviation 1.82 |
| JNJ-42847922 5 mg | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 2 | -0.4 Units on a Scale | Standard Deviation 1.86 |
| JNJ-42847922 5 mg | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 14 | -0.8 Units on a Scale | Standard Deviation 2.15 |
| JNJ-42847922 10 mg | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 2 | -0.2 Units on a Scale | Standard Deviation 1.42 |
| JNJ-42847922 10 mg | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 14 | -0.6 Units on a Scale | Standard Deviation 1.72 |
| JNJ-42847922 20 mg | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 14 | -0.7 Units on a Scale | Standard Deviation 1.9 |
| JNJ-42847922 20 mg | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 2 | -0.5 Units on a Scale | Standard Deviation 1.86 |
| Zolpidem | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 2 | -0.4 Units on a Scale | Standard Deviation 1.68 |
| Zolpidem | Change From Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14 | Day 14 | -0.7 Units on a Scale | Standard Deviation 2.01 |
Secondary
Change From Baseline in LPS as Measured by PSG on Night 13
LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. Negative changes in LPS indicate improvement.
Time frame: Baseline and Night 13
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in LPS as Measured by PSG on Night 13 | -23.74 Minutes | Standard Deviation 61.79 |
| JNJ-42847922 5 mg | Change From Baseline in LPS as Measured by PSG on Night 13 | -27.12 Minutes | Standard Deviation 54.726 |
| JNJ-42847922 10 mg | Change From Baseline in LPS as Measured by PSG on Night 13 | -53.99 Minutes | Standard Deviation 60.292 |
| JNJ-42847922 20 mg | Change From Baseline in LPS as Measured by PSG on Night 13 | -41.19 Minutes | Standard Deviation 59.713 |
| Zolpidem | Change From Baseline in LPS as Measured by PSG on Night 13 | -30.94 Minutes | Standard Deviation 60.236 |
Secondary
Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13
PSG was used to measure the number of night-time awakenings over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement.
Time frame: Baseline, Over 6 hours on Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 1 | -2.08 awakenings | Standard Deviation 6.412 |
| Placebo | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 13 | -2.02 awakenings | Standard Deviation 6.928 |
| JNJ-42847922 5 mg | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 1 | -0.87 awakenings | Standard Deviation 7.224 |
| JNJ-42847922 5 mg | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 13 | 0.93 awakenings | Standard Deviation 7.769 |
| JNJ-42847922 10 mg | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 1 | 0.14 awakenings | Standard Deviation 7.385 |
| JNJ-42847922 10 mg | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 13 | -0.40 awakenings | Standard Deviation 8.352 |
| JNJ-42847922 20 mg | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 13 | -2.13 awakenings | Standard Deviation 7.542 |
| JNJ-42847922 20 mg | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 1 | -0.94 awakenings | Standard Deviation 9.102 |
| Zolpidem | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 1 | -1.14 awakenings | Standard Deviation 8.727 |
| Zolpidem | Change From Baseline in Number of Night-time Awakenings (nNAW) Over 6 Hours on Day 1 and 13 | Day 13 | -0.57 awakenings | Standard Deviation 7.803 |
Secondary
Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13
PSG was used to measure number of night time awakenings per hour. Negative changes in nNAW/hr indicate improvement.
Time frame: Baseline, Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 1 | -0.35 Number of awakenings per hour | Standard Deviation 1.069 |
| Placebo | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 13 | -0.34 Number of awakenings per hour | Standard Deviation 1.155 |
| JNJ-42847922 5 mg | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 1 | -0.14 Number of awakenings per hour | Standard Deviation 1.204 |
| JNJ-42847922 5 mg | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 13 | 0.16 Number of awakenings per hour | Standard Deviation 1.295 |
| JNJ-42847922 10 mg | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 1 | 0.02 Number of awakenings per hour | Standard Deviation 1.231 |
| JNJ-42847922 10 mg | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 13 | -0.07 Number of awakenings per hour | Standard Deviation 1.392 |
| JNJ-42847922 20 mg | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 13 | -0.36 Number of awakenings per hour | Standard Deviation 1.257 |
| JNJ-42847922 20 mg | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 1 | -0.16 Number of awakenings per hour | Standard Deviation 1.517 |
| Zolpidem | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 1 | -0.19 Number of awakenings per hour | Standard Deviation 1.455 |
| Zolpidem | Change From Baseline in Number of Night-time Awakenings Per Hour (nNAW/hr) on Day 1 and 13 | Day 13 | -0.10 Number of awakenings per hour | Standard Deviation 1.3 |
Secondary
Change From Baseline in Number of Sleep Cycles on Day 1 and 13
PSG was used to measure the number of sleep cycles.
Time frame: Baseline, Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 1 | 0.43 sleep cycles | Standard Deviation 1.138 |
| Placebo | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 13 | 0.20 sleep cycles | Standard Deviation 1.222 |
| JNJ-42847922 5 mg | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 1 | 0.40 sleep cycles | Standard Deviation 1.006 |
| JNJ-42847922 5 mg | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 13 | 0.41 sleep cycles | Standard Deviation 1.062 |
| JNJ-42847922 10 mg | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 1 | 0.97 sleep cycles | Standard Deviation 1.049 |
| JNJ-42847922 10 mg | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 13 | 0.77 sleep cycles | Standard Deviation 1.182 |
| JNJ-42847922 20 mg | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 13 | 0.45 sleep cycles | Standard Deviation 1.219 |
| JNJ-42847922 20 mg | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 1 | 0.75 sleep cycles | Standard Deviation 1.155 |
| Zolpidem | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 1 | 0.62 sleep cycles | Standard Deviation 0.941 |
| Zolpidem | Change From Baseline in Number of Sleep Cycles on Day 1 and 13 | Day 13 | 0.32 sleep cycles | Standard Deviation 0.955 |
Secondary
Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14
The PGI-S is a self-reported scale to measure severity of illness using a 6-point scale ranging from 1 to 6, (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, participants rated their severity on the PGI-S scale. Negative changes in scores indicate improvement.
Time frame: Baseline and Day 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14 | 0.00 Unit on a Scale | Full Range -5 |
| JNJ-42847922 5 mg | Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14 | -1.00 Unit on a Scale | Full Range -4 |
| JNJ-42847922 10 mg | Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14 | -1.00 Unit on a Scale | Full Range -4 |
| JNJ-42847922 20 mg | Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14 | -1.00 Unit on a Scale | Full Range -5 |
| Zolpidem | Change From Baseline in Participant's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale Score on Day 14 | -1.00 Unit on a Scale | Full Range -4 |
Secondary
Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Power of Attention is a combination of the speed scores from the three tests of attention, and is established to reflect the ability to focus attention and to process information. Power of Attention was calculated from the sum of the reaction time measured from the attentional tasks (Simple Reaction Time, Choice Reaction Time and Digit Vigilance Speed). Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration.
Time frame: Baseline and Day 14 (Morning)
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 35.88 milliseconds (ms) | Standard Deviation 125.43 |
| JNJ-42847922 5 mg | Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 48.59 milliseconds (ms) | Standard Deviation 137.75 |
| JNJ-42847922 10 mg | Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 67.09 milliseconds (ms) | Standard Deviation 257.67 |
| JNJ-42847922 20 mg | Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 37.07 milliseconds (ms) | Standard Deviation 124.23 |
| Zolpidem | Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 35.38 milliseconds (ms) | Standard Deviation 189.99 |
Secondary
Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Quality of episodic secondary memory is calculated from the sum of 4 tests: Immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. A high score reflects a good ability to store, hold and retrieve information of an episodic nature (that is an event or a name) and a negative change from baseline reflects impairment compared to baseline.
Time frame: Baseline and Day 14 (Morning)
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant is summarized under the 5 mg dose group. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -22.84 units on scale | Standard Deviation 53.73 |
| JNJ-42847922 5 mg | Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -23.15 units on scale | Standard Deviation 46.02 |
| JNJ-42847922 10 mg | Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -33.58 units on scale | Standard Deviation 48.82 |
| JNJ-42847922 20 mg | Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -25.45 units on scale | Standard Deviation 56.37 |
| Zolpidem | Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -37.96 units on scale | Standard Deviation 55.94 |
Secondary
Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
Quality of working memory is a combination of the scores from Spatial Working Memory and Numeric Working Memory tasks, and is established to reflect the ability to temporarily hold numeric and spatial information in memory. Sum of Spatial and Numeric Working Memory sensitivity indices (SI) (accuracy) was used to calculate the quality of working memory. The quality of working memory score was calculated from formulae that combined the accuracy scores for the original as well as the new (distractor) stimuli. The range for both the numeric working memory and spatial working memory tasks SI are -1 to 1. Smaller scores reflect poorer ability (poorer quality of working memory),larger scores reflect better ability (better quality of working memory). Total score is the sum of Spatial Working Memory and Numeric Working Memory (ranges from -2 to 2). Smaller scores reflect poorer ability (poorer quality of working memory), larger scores reflect better ability (better quality of working memory.
Time frame: Baseline and Day 14 (Morning)
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 0.00 Units on scale | Standard Deviation 0.35 |
| JNJ-42847922 5 mg | Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -0.03 Units on scale | Standard Deviation 0.28 |
| JNJ-42847922 10 mg | Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -0.02 Units on scale | Standard Deviation 0.41 |
| JNJ-42847922 20 mg | Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -0.04 Units on scale | Standard Deviation 0.29 |
| Zolpidem | Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 0.05 Units on scale | Standard Deviation 0.28 |
Secondary
Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13
PSG was used to measure REM duration (time to first REM period from sleep onset).
Time frame: Baseline, Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 1 | 10.32 Minutes | Standard Deviation 24.366 |
| Placebo | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 13 | 5.70 Minutes | Standard Deviation 29.875 |
| JNJ-42847922 5 mg | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 1 | 10.23 Minutes | Standard Deviation 28.891 |
| JNJ-42847922 5 mg | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 13 | 6.40 Minutes | Standard Deviation 25.188 |
| JNJ-42847922 10 mg | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 1 | 25.12 Minutes | Standard Deviation 29.495 |
| JNJ-42847922 10 mg | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 13 | 17.42 Minutes | Standard Deviation 28.699 |
| JNJ-42847922 20 mg | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 13 | 12.91 Minutes | Standard Deviation 32.051 |
| JNJ-42847922 20 mg | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 1 | 23.79 Minutes | Standard Deviation 31.175 |
| Zolpidem | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 1 | 5.41 Minutes | Standard Deviation 22.381 |
| Zolpidem | Change From Baseline in Rapid Eye Movement (REM) Duration on Day 1 and 13 | Day 13 | 5.97 Minutes | Standard Deviation 28.811 |
Secondary
Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13
PSG was used to measure the REM latency. REM latency was defined as the time to first REM from sleep onset to reaching the first epoch of REM sleep.
Time frame: Baseline, Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 13 | -26.41 Minute | Standard Deviation 87.903 |
| Placebo | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 1 | -26.60 Minute | Standard Deviation 82.487 |
| JNJ-42847922 5 mg | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 13 | -32.11 Minute | Standard Deviation 86.623 |
| JNJ-42847922 5 mg | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 1 | -38.06 Minute | Standard Deviation 79.396 |
| JNJ-42847922 10 mg | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 13 | -83.89 Minute | Standard Deviation 83.313 |
| JNJ-42847922 10 mg | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 1 | -85.61 Minute | Standard Deviation 84.38 |
| JNJ-42847922 20 mg | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 1 | -88.36 Minute | Standard Deviation 76.551 |
| JNJ-42847922 20 mg | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 13 | -73.40 Minute | Standard Deviation 81.747 |
| Zolpidem | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 13 | -31.59 Minute | Standard Deviation 64.953 |
| Zolpidem | Change From Baseline in Rapid Eye Movement (REM) Latency on Day 1 and 13 | Day 1 | -42.73 Minute | Standard Deviation 67.024 |
Secondary
Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14
PROMIS Sleep Disturbance (PROMIS-SD) Short Form subscale consists of a static 8-item questionnaire. Using a recall period of the past 7 days, it assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Each question has 5 response options ranging in value from 1 to 5. To find the total raw score for a short form with all questions answered, sum the values of the response to each question and a total score ranges from 8 to 40. Lower scores indicate less sleep disturbance. Negative changes in scores indicate improvement.
Time frame: Baseline, Days 8 and 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 8 | -4.9 Unit on a Scale | Standard Deviation 6.81 |
| Placebo | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 14 | -5.7 Unit on a Scale | Standard Deviation 7.75 |
| JNJ-42847922 5 mg | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 8 | -9.0 Unit on a Scale | Standard Deviation 7.13 |
| JNJ-42847922 5 mg | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 14 | -10.8 Unit on a Scale | Standard Deviation 7.64 |
| JNJ-42847922 10 mg | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 8 | -9.2 Unit on a Scale | Standard Deviation 7.17 |
| JNJ-42847922 10 mg | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 14 | -10.3 Unit on a Scale | Standard Deviation 7.39 |
| JNJ-42847922 20 mg | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 14 | -9.5 Unit on a Scale | Standard Deviation 7.93 |
| JNJ-42847922 20 mg | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 8 | -9.6 Unit on a Scale | Standard Deviation 8.16 |
| Zolpidem | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 8 | -8.3 Unit on a Scale | Standard Deviation 7.31 |
| Zolpidem | Change From Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System - Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14 | Day 14 | -10.1 Unit on a Scale | Standard Deviation 8.06 |
Secondary
Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13
Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percentage). Positive changes in SE indicate improvement.
Time frame: Baseline, Nights 1 and 13
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 1 | 7.74 Percentage of efficient sleep | Standard Deviation 18.031 |
| Placebo | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 13 | 7.99 Percentage of efficient sleep | Standard Deviation 17.322 |
| JNJ-42847922 5 mg | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 1 | 10.18 Percentage of efficient sleep | Standard Deviation 12.818 |
| JNJ-42847922 5 mg | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 13 | 9.51 Percentage of efficient sleep | Standard Deviation 15.154 |
| JNJ-42847922 10 mg | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 1 | 16.92 Percentage of efficient sleep | Standard Deviation 12.626 |
| JNJ-42847922 10 mg | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 13 | 13.67 Percentage of efficient sleep | Standard Deviation 16.037 |
| JNJ-42847922 20 mg | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 13 | 13.56 Percentage of efficient sleep | Standard Deviation 17.199 |
| JNJ-42847922 20 mg | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 1 | 16.86 Percentage of efficient sleep | Standard Deviation 14.963 |
| Zolpidem | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 1 | 13.29 Percentage of efficient sleep | Standard Deviation 12.317 |
| Zolpidem | Change From Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13 | Night 13 | 8.27 Percentage of efficient sleep | Standard Deviation 16.323 |
Secondary
Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
The sum of the speed measures from the two working memory tasks (Spatial and Numeric) and the two recognition tasks (Word and Picture). Speed of Memory combines reaction times from Spatial Working Memory (range:150 to 30000 millisecond \[ms\]), Numeric Working Memory (150 to 30000 ms), Word Recognition (250 to 30000 ms) and Picture recognition (250 to 30000 ms) tasks. The total reaction time (sum of above 4 reaction times) measures memory retrieval speed which ranges from 800 to 120000 ms. Slower reaction time reflect poorer ability and faster reaction time reflect better ability.
Time frame: Baseline and Day 14 (Morning)
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -104.75 millisecond | Standard Deviation 787.74 |
| JNJ-42847922 5 mg | Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 258.38 millisecond | Standard Deviation 719.56 |
| JNJ-42847922 10 mg | Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | 7.57 millisecond | Standard Deviation 806.27 |
| JNJ-42847922 20 mg | Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -65.67 millisecond | Standard Deviation 761.77 |
| Zolpidem | Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning) | -83.70 millisecond | Standard Deviation 1060.38 |
Secondary
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW)
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. CSD-M parameters analyzed include: s-nNAW. Negative change in s-nNAW indicate improvement.
Time frame: Baseline, Days 2 and 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 14 | 0.10 awakenings | Standard Deviation 1.234 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 2 | 0.64 awakenings | Standard Deviation 2.197 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 14 | 0.04 awakenings | Standard Deviation 1.58 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 2 | 0.21 awakenings | Standard Deviation 1.465 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 2 | 0.49 awakenings | Standard Deviation 1.465 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 14 | 0.05 awakenings | Standard Deviation 1.32 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 2 | 0.27 awakenings | Standard Deviation 1.418 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 14 | -0.02 awakenings | Standard Deviation 1.175 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 14 | -0.22 awakenings | Standard Deviation 1.376 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW) | Day 2 | 0.38 awakenings | Standard Deviation 6.076 |
Secondary
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement.
Time frame: Baseline, Days 2 and 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 2 | 15.20 Minutes | Standard Deviation 61.761 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 14 | 10.92 Minutes | Standard Deviation 68.201 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO: Day 2 | 0.81 Minutes | Standard Deviation 75.475 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO : Day 14 | -5.60 Minutes | Standard Deviation 55.955 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 2 | -12.64 Minutes | Standard Deviation 96.051 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 14 | 3.30 Minutes | Standard Deviation 89.019 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 2 | 4.90 Minutes | Standard Deviation 92.105 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 14 | 29.34 Minutes | Standard Deviation 83.772 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 2 | -3.99 Minutes | Standard Deviation 46.858 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO: Day 2 | -5.47 Minutes | Standard Deviation 61.067 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO : Day 14 | -18.25 Minutes | Standard Deviation 56.719 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 14 | -8.81 Minutes | Standard Deviation 45.936 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO : Day 14 | -25.20 Minutes | Standard Deviation 58.872 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 2 | 29.25 Minutes | Standard Deviation 67.934 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 2 | -16.49 Minutes | Standard Deviation 42.699 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO: Day 2 | -18.54 Minutes | Standard Deviation 51.301 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 14 | -31.33 Minutes | Standard Deviation 36.888 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 14 | 36.79 Minutes | Standard Deviation 88.379 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO : Day 14 | -20.16 Minutes | Standard Deviation 65.568 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 14 | -33.93 Minutes | Standard Deviation 37.274 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO: Day 2 | -13.28 Minutes | Standard Deviation 48.225 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 14 | 45.35 Minutes | Standard Deviation 81.983 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 2 | 34.50 Minutes | Standard Deviation 76.904 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 2 | -27.60 Minutes | Standard Deviation 34.456 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 2 | 37.07 Minutes | Standard Deviation 71.297 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO: Day 2 | -15.99 Minutes | Standard Deviation 84.549 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 14 | -14.53 Minutes | Standard Deviation 53.705 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sTST: Day 14 | 27.68 Minutes | Standard Deviation 90.387 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sWASO : Day 14 | -17.56 Minutes | Standard Deviation 51.007 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST) | sSOL: Day 2 | -24.98 Minutes | Standard Deviation 30.395 |
Secondary
Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
The CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality (sQUAL) and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.
Time frame: Baseline, Days 2 and 14
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 2 | 0.07 Units on a Scale | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 14 | 0.26 Units on a Scale | Standard Deviation 0.826 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 2 | 0.11 Units on a Scale | Standard Deviation 0.995 |
| Placebo | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 14 | 0.26 Units on a Scale | Standard Deviation 1.024 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 2 | 0.14 Units on a Scale | Standard Deviation 0.865 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 14 | 0.43 Units on a Scale | Standard Deviation 1.172 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 14 | 0.39 Units on a Scale | Standard Deviation 1.081 |
| JNJ-42847922 5 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 2 | 0.14 Units on a Scale | Standard Deviation 1.054 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 14 | 0.79 Units on a Scale | Standard Deviation 1.189 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 14 | 0.51 Units on a Scale | Standard Deviation 1.005 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 2 | 0.49 Units on a Scale | Standard Deviation 0.896 |
| JNJ-42847922 10 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 2 | 0.34 Units on a Scale | Standard Deviation 0.852 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 2 | 0.58 Units on a Scale | Standard Deviation 1.05 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 14 | 0.59 Units on a Scale | Standard Deviation 1.018 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 14 | 0.67 Units on a Scale | Standard Deviation 1.159 |
| JNJ-42847922 20 mg | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 2 | 0.49 Units on a Scale | Standard Deviation 1.091 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 14 | 0.52 Units on a Scale | Standard Deviation 1.084 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL: Day 2 | 0.66 Units on a Scale | Standard Deviation 0.818 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 14 | 0.41 Units on a Scale | Standard Deviation 1.051 |
| Zolpidem | Change From Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH: Day 2 | 0.41 Units on a Scale | Standard Deviation 0.876 |
Secondary
Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13
PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement.
Time frame: Baseline, Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 1 | 12.05 Minutes | Standard Deviation 57.535 |
| Placebo | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 13 | 11.08 Minutes | Standard Deviation 45.714 |
| JNJ-42847922 5 mg | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 1 | 10.71 Minutes | Standard Deviation 61.015 |
| JNJ-42847922 5 mg | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 13 | 32.13 Minutes | Standard Deviation 70.549 |
| JNJ-42847922 10 mg | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 1 | 23.11 Minutes | Standard Deviation 73.749 |
| JNJ-42847922 10 mg | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 13 | 33.12 Minutes | Standard Deviation 71.826 |
| JNJ-42847922 20 mg | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 13 | 48.92 Minutes | Standard Deviation 88.909 |
| JNJ-42847922 20 mg | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 1 | 53.90 Minutes | Standard Deviation 92.802 |
| Zolpidem | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 1 | 35.63 Minutes | Standard Deviation 74.617 |
| Zolpidem | Change From Baseline in Time to First Awakening After Sleep on Day 1 and 13 | Day 13 | 27.55 Minutes | Standard Deviation 75.08 |
Secondary
Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13
TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.
Time frame: Baseline, Over 6 hours on Nights 1 and 13
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 1 | 25.50 Minutes | Standard Deviation 72.146 |
| Placebo | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 13 | 33.16 Minutes | Standard Deviation 71.488 |
| JNJ-42847922 5 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 1 | 43.26 Minutes | Standard Deviation 50.771 |
| JNJ-42847922 5 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 13 | 39.80 Minutes | Standard Deviation 66.556 |
| JNJ-42847922 10 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 1 | 76.47 Minutes | Standard Deviation 50.711 |
| JNJ-42847922 10 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 13 | 66.03 Minutes | Standard Deviation 62.995 |
| JNJ-42847922 20 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 13 | 67.66 Minutes | Standard Deviation 66.254 |
| JNJ-42847922 20 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 1 | 80.49 Minutes | Standard Deviation 56.216 |
| Zolpidem | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 1 | 53.70 Minutes | Standard Deviation 57.688 |
| Zolpidem | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13 | Night 13 | 35.84 Minutes | Standard Deviation 64.95 |
Secondary
Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13
TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement.
Time frame: Baseline, Over 8 hours on Nights 1 and 13
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 13 | 38.45 Minutes | Standard Deviation 83.177 |
| Placebo | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 1 | 37.03 Minutes | Standard Deviation 86.539 |
| JNJ-42847922 5 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 13 | 45.72 Minutes | Standard Deviation 72.64 |
| JNJ-42847922 5 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 1 | 47.85 Minutes | Standard Deviation 64.499 |
| JNJ-42847922 10 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 13 | 64.84 Minutes | Standard Deviation 77.358 |
| JNJ-42847922 10 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 1 | 81.20 Minutes | Standard Deviation 60.607 |
| JNJ-42847922 20 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 1 | 81.07 Minutes | Standard Deviation 71.581 |
| JNJ-42847922 20 mg | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 13 | 64.27 Minutes | Standard Deviation 82.377 |
| Zolpidem | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 13 | 39.26 Minutes | Standard Deviation 77.773 |
| Zolpidem | Change From Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13 | Night 1 | 63.88 Minutes | Standard Deviation 59.115 |
Secondary
Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13
PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Total time spent was sum of N1, N2 and N3. Positive changes in NREM duration indicate improvement.
Time frame: Baseline, Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 13 | 32.74 Minutes | Standard Deviation 61.726 |
| Placebo | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 1 | 27.87 Minutes | Standard Deviation 68.202 |
| JNJ-42847922 5 mg | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 1 | 37.62 Minutes | Standard Deviation 49.817 |
| JNJ-42847922 5 mg | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 13 | 39.33 Minutes | Standard Deviation 61.524 |
| JNJ-42847922 10 mg | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 13 | 47.41 Minutes | Standard Deviation 59.791 |
| JNJ-42847922 10 mg | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 1 | 56.08 Minutes | Standard Deviation 45.218 |
| JNJ-42847922 20 mg | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 1 | 57.29 Minutes | Standard Deviation 54.245 |
| JNJ-42847922 20 mg | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 13 | 51.37 Minutes | Standard Deviation 59.31 |
| Zolpidem | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 13 | 33.28 Minutes | Standard Deviation 62.466 |
| Zolpidem | Change From Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep on Day 1 and 13 | Day 1 | 58.47 Minutes | Standard Deviation 52.803 |
Secondary
Change From Baseline in Wake After Final Awakening on Day 1 and 13
PSG was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement.
Time frame: Baseline, Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 1 | -13.63 Minutes | Standard Deviation 50.958 |
| Placebo | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 13 | -5.32 Minutes | Standard Deviation 55.112 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 1 | -0.28 Minutes | Standard Deviation 29.552 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 13 | -0.39 Minutes | Standard Deviation 31.519 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 1 | 2.80 Minutes | Standard Deviation 38.492 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 13 | 12.42 Minutes | Standard Deviation 62.515 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 13 | 5.62 Minutes | Standard Deviation 48.641 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 1 | 7.21 Minutes | Standard Deviation 45.189 |
| Zolpidem | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 1 | -5.40 Minutes | Standard Deviation 29.473 |
| Zolpidem | Change From Baseline in Wake After Final Awakening on Day 1 and 13 | Day 13 | -2.17 Minutes | Standard Deviation 29.376 |
Secondary
Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8
Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement.
Time frame: Baseline, Days 1 and 13 (Hours 1 to 8)
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 1 | -5.57 Minutes | Standard Deviation 18.316 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 13 | 0.43 Minutes | Standard Deviation 12.083 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2): Day 1 | 1.06 Minutes | Standard Deviation 18.481 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2):Day 13 | 1.11 Minutes | Standard Deviation 18.504 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 1 | -3.40 Minutes | Standard Deviation 13.074 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 13 | -5.70 Minutes | Standard Deviation 17.681 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 1 | -5.33 Minutes | Standard Deviation 17.109 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 13 | -5.49 Minutes | Standard Deviation 18.185 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 1 | -3.36 Minutes | Standard Deviation 22.284 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 13 | -4.96 Minutes | Standard Deviation 22.597 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 1 | -1.06 Minutes | Standard Deviation 17.258 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 13 | -4.69 Minutes | Standard Deviation 19.658 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 1 | -5.01 Minutes | Standard Deviation 22.247 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 13 | -3.57 Minutes | Standard Deviation 21.828 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 1 | -7.52 Minutes | Standard Deviation 23.369 |
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 13 | -1.73 Minutes | Standard Deviation 24.898 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 13 | -4.92 Minutes | Standard Deviation 18.271 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 13 | -4.06 Minutes | Standard Deviation 20.776 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 1 | -6.16 Minutes | Standard Deviation 15.82 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 1 | 0.66 Minutes | Standard Deviation 21.311 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 13 | -3.47 Minutes | Standard Deviation 16.754 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 1 | -3.91 Minutes | Standard Deviation 12.037 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2):Day 13 | -4.12 Minutes | Standard Deviation 14.596 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 13 | -4.78 Minutes | Standard Deviation 8.824 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 1 | -3.55 Minutes | Standard Deviation 10.51 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 1 | -5.71 Minutes | Standard Deviation 19.784 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 13 | -0.31 Minutes | Standard Deviation 18.562 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2): Day 1 | -5.72 Minutes | Standard Deviation 11.817 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 13 | -0.63 Minutes | Standard Deviation 20.118 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 13 | -3.09 Minutes | Standard Deviation 21.426 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 1 | -4.46 Minutes | Standard Deviation 22.383 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 1 | -4.73 Minutes | Standard Deviation 13.193 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 13 | -1.50 Minutes | Standard Deviation 21.145 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2):Day 13 | -9.04 Minutes | Standard Deviation 17.034 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 1 | -11.05 Minutes | Standard Deviation 13.272 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 13 | -8.10 Minutes | Standard Deviation 12.446 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 1 | -9.67 Minutes | Standard Deviation 14.495 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 13 | -9.57 Minutes | Standard Deviation 14.483 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 1 | -0.65 Minutes | Standard Deviation 22.278 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 1 | -7.53 Minutes | Standard Deviation 14.371 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 13 | -5.34 Minutes | Standard Deviation 20.232 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 1 | -5.44 Minutes | Standard Deviation 17.51 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 13 | 0.56 Minutes | Standard Deviation 22.721 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 1 | -3.84 Minutes | Standard Deviation 16.756 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 1 | -3.44 Minutes | Standard Deviation 12.969 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 13 | 1.88 Minutes | Standard Deviation 23.845 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 13 | -7.05 Minutes | Standard Deviation 14.569 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2): Day 1 | -9.62 Minutes | Standard Deviation 16.721 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 13 | -7.97 Minutes | Standard Deviation 17.016 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 13 | 1.24 Minutes | Standard Deviation 20.858 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 1 | -7.78 Minutes | Standard Deviation 18.348 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 13 | 1.16 Minutes | Standard Deviation 23.642 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 13 | -7.37 Minutes | Standard Deviation 20.872 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 13 | -6.99 Minutes | Standard Deviation 15.331 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 1 | -1.61 Minutes | Standard Deviation 19.349 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2):Day 13 | -9.64 Minutes | Standard Deviation 14.963 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 1 | -6.37 Minutes | Standard Deviation 14.213 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2): Day 1 | -10.82 Minutes | Standard Deviation 13.658 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 13 | -6.21 Minutes | Standard Deviation 14.14 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 1 | -9.64 Minutes | Standard Deviation 13.055 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 1 | -7.44 Minutes | Standard Deviation 15.834 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 1 | 1.25 Minutes | Standard Deviation 22.046 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 1 | -9.74 Minutes | Standard Deviation 14.727 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 13 | -7.47 Minutes | Standard Deviation 13.004 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 1 | -6.15 Minutes | Standard Deviation 13.756 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 13 | -5.03 Minutes | Standard Deviation 16.306 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 1 | -3.95 Minutes | Standard Deviation 20.149 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 1 | -9.62 Minutes | Standard Deviation 14.141 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 13 | -4.90 Minutes | Standard Deviation 11.821 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 13 | -7.00 Minutes | Standard Deviation 15.727 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 1 | -1.46 Minutes | Standard Deviation 19.965 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 8): Day 13 | -3.22 Minutes | Standard Deviation 22.343 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 3): Day 13 | -5.12 Minutes | Standard Deviation 18.14 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 5): Day 1 | -4.34 Minutes | Standard Deviation 16.15 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 1): Day 1 | -5.40 Minutes | Standard Deviation 12.086 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 6): Day 13 | 0.84 Minutes | Standard Deviation 20.768 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 4): Day 1 | -6.23 Minutes | Standard Deviation 16.471 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 7): Day 13 | -0.75 Minutes | Standard Deviation 18.096 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2):Day 13 | -4.37 Minutes | Standard Deviation 16.883 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Measured Hourly on Days 1 and 13 From Hour 1 to Hour 8 | WASO (hour 2): Day 1 | -7.68 Minutes | Standard Deviation 14.812 |
Secondary
Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1
PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 1. Negative changes in WASO indicate improvement.
Time frame: Baseline and over first 6 hours on Night 1
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | -15.05 Minutes | Standard Deviation 57.485 |
| JNJ-42847922 5 mg | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | -22.70 Minutes | Standard Deviation 45.904 |
| JNJ-42847922 10 mg | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | -42.57 Minutes | Standard Deviation 40.011 |
| JNJ-42847922 20 mg | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | -44.69 Minutes | Standard Deviation 42.823 |
| Zolpidem | Change From Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1 | -29.04 Minutes | Standard Deviation 46.779 |
Secondary
Change From Baseline in Wake During Total Sleep Period on Day 1 and 13
PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement.
Time frame: Baseline, Day 1 and 13
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 1 | -13.79 Minutes | Standard Deviation 63.082 |
| Placebo | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 13 | -18.83 Minutes | Standard Deviation 59.005 |
| JNJ-42847922 5 mg | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 1 | -27.47 Minutes | Standard Deviation 58.188 |
| JNJ-42847922 5 mg | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 13 | -19.79 Minutes | Standard Deviation 60.626 |
| JNJ-42847922 10 mg | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 1 | -49.64 Minutes | Standard Deviation 47.106 |
| JNJ-42847922 10 mg | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 13 | -42.57 Minutes | Standard Deviation 53.867 |
| JNJ-42847922 20 mg | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 13 | -41.95 Minutes | Standard Deviation 64.846 |
| JNJ-42847922 20 mg | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 1 | -52.25 Minutes | Standard Deviation 40.828 |
| Zolpidem | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 1 | -32.36 Minutes | Standard Deviation 53.737 |
| Zolpidem | Change From Baseline in Wake During Total Sleep Period on Day 1 and 13 | Day 13 | -20.58 Minutes | Standard Deviation 56.799 |
Secondary
Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13
PSG was used to measure the time to wake after initial sleep onset (WASO) over the first 6 hours on Night 13. Negative changes in WASO indicate improvement.
Time frame: Baseline and over first 6 hours on Night 13
Population: Full analysis set included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | -17.80 Minutes | Standard Deviation 52.369 |
| JNJ-42847922 5 mg | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | -14.63 Minutes | Standard Deviation 57.207 |
| JNJ-42847922 10 mg | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | -30.74 Minutes | Standard Deviation 52.835 |
| JNJ-42847922 20 mg | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | -38.40 Minutes | Standard Deviation 53.661 |
| Zolpidem | Change From Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13 | -20.22 Minutes | Standard Deviation 46.465 |
Secondary
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to prior night's sleep. Negative change in sSOL, sWASO indicate improvement and positive change in Subjective Total Sleep Time (sTST) indicates improvement.
Time frame: Day 14 to Day 17
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sSOL | -20.56 Minutes | Standard Deviation 74.145 |
| Placebo | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sTST | 30.95 Minutes | Standard Deviation 101.367 |
| Placebo | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sWASO | -12.39 Minutes | Standard Deviation 57.711 |
| JNJ-42847922 5 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sWASO | -0.76 Minutes | Standard Deviation 66.663 |
| JNJ-42847922 5 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sSOL | -4.83 Minutes | Standard Deviation 43.769 |
| JNJ-42847922 5 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sTST | 13.07 Minutes | Standard Deviation 102.093 |
| JNJ-42847922 10 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sWASO | -2.13 Minutes | Standard Deviation 41.505 |
| JNJ-42847922 10 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sSOL | 9.67 Minutes | Standard Deviation 29.798 |
| JNJ-42847922 10 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sTST | 6.96 Minutes | Standard Deviation 96.664 |
| JNJ-42847922 20 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sSOL | 15.55 Minutes | Standard Deviation 32.327 |
| JNJ-42847922 20 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sTST | 19.71 Minutes | Standard Deviation 66.447 |
| JNJ-42847922 20 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sWASO | -10.80 Minutes | Standard Deviation 63.672 |
| Zolpidem | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sWASO | 3.76 Minutes | Standard Deviation 58.805 |
| Zolpidem | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sSOL | 9.57 Minutes | Standard Deviation 72.253 |
| Zolpidem | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary-Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and sTST | sTST | -7.95 Minutes | Standard Deviation 102.183 |
Secondary
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW)
CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: s-nNAW. Negative change in s-nNAW indicate improvement.
Time frame: Day 14 to Day 17
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) | 0.16 awakenings | Standard Deviation 3.525 |
| JNJ-42847922 5 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) | -0.59 awakenings | Standard Deviation 2.009 |
| JNJ-42847922 10 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) | -0.35 awakenings | Standard Deviation 1.217 |
| JNJ-42847922 20 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) | -0.36 awakenings | Standard Deviation 1.052 |
| Zolpidem | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW) | -0.34 awakenings | Standard Deviation 1.396 |
Secondary
Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. Sleep quality (sQUAL) and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep (sFRESH). CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement.
Time frame: Day 14 to Day 17
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH | 0.13 Units on a Scale | Standard Deviation 1.085 |
| Placebo | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL | 0.19 Units on a Scale | Standard Deviation 1.242 |
| JNJ-42847922 5 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH | 0.17 Units on a Scale | Standard Deviation 1.011 |
| JNJ-42847922 5 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL | 0.24 Units on a Scale | Standard Deviation 1.129 |
| JNJ-42847922 10 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH | 0.04 Units on a Scale | Standard Deviation 1.017 |
| JNJ-42847922 10 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL | -0.07 Units on a Scale | Standard Deviation 1.083 |
| JNJ-42847922 20 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL | 0.02 Units on a Scale | Standard Deviation 1.12 |
| JNJ-42847922 20 mg | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH | 0.11 Units on a Scale | Standard Deviation 1.073 |
| Zolpidem | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sFRESH | -0.03 Units on a Scale | Standard Deviation 0.898 |
| Zolpidem | Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary-Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL) | sQUAL | -0.12 Units on a Scale | Standard Deviation 1.01 |
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Twelve-lead ECGs were recorded in a supine position and different ECG intervals (Respiratory rate \[RR\], PR, time for ventricular depolarization \[QRS\], and total time from ventricular depolarization to complete repolarization \[QT\]) and heart rate was measured. This included heart rate:\<=50 beats per minute (bpm) and \>=100 bpm; PR interval \<=120 millisecond (msec) and \>=200 msec; QRS interval: \<=60 msec and \>=120 msec; QT interval:\<=200 msec and \>=500 msec.
Time frame: Up to Day 14
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: >=120 msec | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: <=120 msec | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate: <=50 bpm | 10 Participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: <=60 msec | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: >=200 msec | 4 Participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: <=200 msec | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: >=500 msec | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate:>=100 bpm | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: <=200 msec | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: >=120 msec | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate:>=100 bpm | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: >=500 msec | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: <=120 msec | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate: <=50 bpm | 7 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: >=200 msec | 4 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: <=60 msec | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: >=500 msec | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: <=60 msec | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: >=120 msec | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: >=200 msec | 4 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate:>=100 bpm | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate: <=50 bpm | 5 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: <=120 msec | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: <=200 msec | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: >=200 msec | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate: <=50 bpm | 6 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate:>=100 bpm | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: <=120 msec | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: <=60 msec | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: >=120 msec | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: <=200 msec | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: >=500 msec | 1 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: >=200 msec | 7 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: >=500 msec | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QT interval: <=200 msec | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | PR interval: <=120 msec | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate:>=100 bpm | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Heart rate: <=50 bpm | 6 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: >=120 msec | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QRS interval: <=60 msec | 0 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant laboratory abnormalities were reported. Blood samples for serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, chloride, creatine Kinase, gamma glutamyl transferase, lactate dehydrogenase, phosphate, potassium, sodium), and urinalysis (bilirubin, protein) were collected for clinical laboratory testing.
Time frame: Up to Day 15
Population: Analysis population was SAS. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here,'n' (number analyzed) signifies number of participants who were evaluable for specified categories. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922.This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Alkaline Phosphatase: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Aspartate Aminotransferase: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Alanine Aminotransferase: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Bilirubin: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally low | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatine Kinase: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatinine: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Direct Bilirubin: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Gamma Glutamyl Transferase: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Lactate Dehydrogenase: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Protein: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Alanine Aminotransferase: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Protein: Abnormally low | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatine Kinase: Abnormally high | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Lactate Dehydrogenase: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Aspartate Aminotransferase: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Alkaline Phosphatase: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatinine: Abnormally high | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Gamma Glutamyl Transferase: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bilirubin: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Direct Bilirubin: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bilirubin: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Gamma Glutamyl Transferase: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Lactate Dehydrogenase: Abnormally high | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Alkaline Phosphatase: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Aspartate Aminotransferase: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally high | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Protein: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatine Kinase: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Direct Bilirubin: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatinine: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Alanine Aminotransferase: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Aspartate Aminotransferase: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally high | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Bilirubin: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Protein: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatine Kinase: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatinine: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Direct Bilirubin: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Gamma Glutamyl Transferase: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Lactate Dehydrogenase: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Alanine Aminotransferase: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Laboratory Abnormalities | Alkaline Phosphatase: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Gamma Glutamyl Transferase: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Direct Bilirubin: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatinine: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Alkaline Phosphatase: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Alanine Aminotransferase: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Protein: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Creatine Kinase: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Bilirubin: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Chloride: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Bicarbonate: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Albumin: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Calcium: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Potassium: Abnormally high | 2 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Lactate Dehydrogenase: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Aspartate Aminotransferase: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Phosphate: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Laboratory Abnormalities | Sodium: Abnormally high | 0 Participants |
Secondary
Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities
Clinically significant vital signs (pulse, supine and standing blood pressure (systolic and diastolic), and oral, temperature) and physical abnormalities (body weight) were reported. Abnormally low parameters included pulse (bpm)- decrease value from baseline greater than or equal to (\>=) 15 to \<=50; Systolic BP (mmHg \[Millimeter of mercury\])- decrease value from baseline \>=20 to \<=90; Diastolic BP- decrease value from baseline \>=15 to \<=50; weight (Kilogram\[Kg\])- decrease from baseline \>=7%; Body temperature (Celsius \[C\])- \<35.5. Abnormally high parameters included pulse- increase value from baseline \>=15 to \>=100; Systolic BP(mmHg)- increase from baseline of \>=20 to \>=180; Diastolic BP- increase value from baseline \>=15 to \>=105; weight(Kg)- increase from baseline of \>=7%; body temperature (C)- \>37.5.
Time frame: Up to Day 15
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses. Here, 'n' (number analyzed) signifies number of participants who were evaluable for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally high | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally low | 3 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally high | 8 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally low | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally high | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally high | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally low | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally low | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally low | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally high | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally low | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally low | 2 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally high | 1 Participants |
| Placebo | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally high | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally low | 2 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally high | 7 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally low | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally high | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally low | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally low | 3 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally high | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally low | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally low | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally low | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally high | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally low | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally high | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally low | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally low | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally high | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally high | 6 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally low | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally low | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally high | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally low | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally low | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally high | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally low | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally low | 1 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally low | 2 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally high | 1 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally low | 1 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally low | 2 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally low | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Systolic BP: Abnormally low | 5 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally high | 1 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Diastolic BP: Abnormally low | 4 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Pulse Rate: Abnormally high | 11 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Standing Diastolic BP: Abnormally high | 1 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Temperature: Abnormally high | 1 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Weight: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Systolic BP: Abnormally high | 0 Participants |
| Zolpidem | Number of Participants With Clinically Significant Vital Signs and Physical Abnormalities | Supine Pulse Rate: Abnormally low | 0 Participants |
Secondary
Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score
C-SSRS is a questionnaire designed to solicit occurrence, severity, frequency of suicidal ideation/behaviors using following scores: Suicidal Ideation-1:Wish to be Dead; 2:Non-specific Active Suicidal Thoughts; 3:Active Suicidal Ideation with Any Methods without Intent to Act; 4:Active Suicidal Ideation with Some Intent to Act; 5:Active Suicidal Ideation with Specific Plan/Intent; Suicidal Behavior-6:Preparatory Acts; 7:Aborted Attempt; 8:Interrupted Attempt; 9:Actual Attempt; 10:Completed Suicide. If no events qualify for score of 1-10, score 0 indicate no event that can be assessed on basis of C-SSRS. Higher scores= greater severity.
Time frame: Day 14
Population: SAS included all participants who were randomly assigned to drug and received at least 1 dose of drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 5: Suicidal Ideation With Plan and Intent | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 6: Preparatory Acts or Behavior | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 0: No Event | 69 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 8: Interrupted Attempt | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 3: Suicidal Ideation Without Plan and Intent | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 9: Actual Attempt | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 10: Completed Suicide | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 2: Non-Specific Active Suicidal Thoughts | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 7: Aborted Attempt | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 4: Suicidal Ideation Intent to Act Without Plan | 0 Participants |
| Placebo | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 1: Wish to be Dead | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 4: Suicidal Ideation Intent to Act Without Plan | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 6: Preparatory Acts or Behavior | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 5: Suicidal Ideation With Plan and Intent | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 1: Wish to be Dead | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 0: No Event | 70 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 9: Actual Attempt | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 2: Non-Specific Active Suicidal Thoughts | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 10: Completed Suicide | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 8: Interrupted Attempt | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 3: Suicidal Ideation Without Plan and Intent | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 7: Aborted Attempt | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 5: Suicidal Ideation With Plan and Intent | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 0: No Event | 72 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 1: Wish to be Dead | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 2: Non-Specific Active Suicidal Thoughts | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 3: Suicidal Ideation Without Plan and Intent | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 4: Suicidal Ideation Intent to Act Without Plan | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 6: Preparatory Acts or Behavior | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 7: Aborted Attempt | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 8: Interrupted Attempt | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 9: Actual Attempt | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 10: Completed Suicide | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 3: Suicidal Ideation Without Plan and Intent | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 0: No Event | 69 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 1: Wish to be Dead | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 10: Completed Suicide | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 9: Actual Attempt | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 2: Non-Specific Active Suicidal Thoughts | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 5: Suicidal Ideation With Plan and Intent | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 7: Aborted Attempt | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 8: Interrupted Attempt | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 4: Suicidal Ideation Intent to Act Without Plan | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 6: Preparatory Acts or Behavior | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 0: No Event | 70 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 6: Preparatory Acts or Behavior | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 3: Suicidal Ideation Without Plan and Intent | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 7: Aborted Attempt | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 2: Non-Specific Active Suicidal Thoughts | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 10: Completed Suicide | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 8: Interrupted Attempt | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 1: Wish to be Dead | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 9: Actual Attempt | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 5: Suicidal Ideation With Plan and Intent | 0 Participants |
| Zolpidem | Number of Participants With Suicidal Ideation and Behavior as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Score | Score 4: Suicidal Ideation Intent to Act Without Plan | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent adverse events are adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date.
Time frame: Up to Day 17
Population: Safety analysis set (SAS) included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 37 Participants |
| JNJ-42847922 5 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 29 Participants |
| JNJ-42847922 10 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 23 Participants |
| JNJ-42847922 20 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 21 Participants |
| Zolpidem | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | 31 Participants |
Secondary
Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest
Treatment-emergent serious adverse events are serious adverse events with an onset date occurring at or after the initial administration of study drug through the Day 17 telephone contact date, or the day of last dose plus 3 days for participants without the Day 17 telephone contact date. Events of special interest included: Cataplexy; Sleep paralysis; Complex sleep-related behaviors such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); Abnormal dreams; Falls.
Time frame: Up to Day 17
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. One participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Treatment-emergent Serious AE | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Events of Special Interest | 2 Participants |
| JNJ-42847922 5 mg | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Treatment-emergent Serious AE | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Events of Special Interest | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Treatment-emergent Serious AE | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Events of Special Interest | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Events of Special Interest | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Treatment-emergent Serious AE | 1 Participants |
| Zolpidem | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Treatment-emergent Serious AE | 1 Participants |
| Zolpidem | Number of Participants With Treatment-Emergent Serious Adverse Events and Events of Special Interest | Events of Special Interest | 4 Participants |
Secondary
Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
PWC-20 is a reliable, sensitive instrument having 20-items used to assess potential withdrawal symptoms following cessation of treatment. Items are as follows: Loss of Appetite, Nausea-Vomiting, Diarrhea, Anxiety-Nervousness, Irritability, Dysphoric Mood-Depression, Insomnia, Fatigue, Poor Coordination, Restlessness, Diaphoresis, Tremor, Dizziness, Headaches, Stiffness, Weakness, Increased Acuity Sound Smell Touch (IASST), Paresthesias, Remember, Derealization. Each item score ranges from 0 (not present)-3 (severe), where higher scores = more affected condition. Total score ranges from 0-60, where higher score indicates more affected condition. PWC-20 score was imputed as follows: sum of the non-missing items \* (total number of items) / (number of items non-missing).
Time frame: Day 14 to Day 17
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. 1 participant who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: No Symptoms | 66 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Improved Symptoms | 21 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Symptoms Present and Unchanged | 5 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: New or Worsened Symptoms | 13 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: No Symptoms | 61 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Improved Symptoms | 8 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Improved Symptoms | 6 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Symptoms Present and Unchanged | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Symptoms Present and Unchanged | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: New/Worsened Symptoms | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:No Symptoms | 64 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:No Symptoms | 55 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Symptoms Present and Unchanged | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Improved Symptoms | 3 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Improved Symptoms | 9 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Symptoms Present and Unchanged | 3 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:No Symptoms | 61 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:No Symptoms | 64 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Symptoms Present and Unchanged | 3 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:New or Worsened Symptoms | 5 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: No Symptoms | 64 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Improved Symptoms | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Symptoms Present and Unchanged | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Symptoms Present and Unchanged | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Improved Symptoms | 4 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Symptoms Present and Unchanged | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:No Symptoms | 50 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:No Symptoms | 62 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Improved Symptoms | 9 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Symptoms Present and Unchanged | 5 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: No Symptoms | 65 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Improved Symptoms | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Symptoms Present and Unchanged | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:New or Worsened Symptoms | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:No Symptoms | 56 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: New or Worsened Symptoms | 4 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: No Symptoms | 67 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Improved Symptoms | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Symptoms Present and Unchanged | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Symptoms Present and Unchanged | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: No Symptoms | 65 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Improved Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Symptoms Present and Unchanged | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Symptoms Present and Unchanged | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: No Symptoms | 64 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Improved Symptoms | 3 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Improved Symptoms | 3 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Improved Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Symptoms Present and Unchanged | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Improved Symptoms | 9 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: New or Worsened Symptoms | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:No Symptoms | 63 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability: No Symptoms | 58 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Symptoms Present and Unchanged | 3 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: New or Worsened Symptoms | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: No Symptoms | 66 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Improved Symptoms | 6 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Improved Symptoms | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Symptoms Present and Unchanged | 0 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Symptoms Present and Unchanged | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Improved Symptoms | 4 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: New or Worsened Symptoms | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:New or Worsened Symptoms | 1 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: No Symptoms | 12 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:New or Worsened Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Improved Symptoms | 2 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Improved Symptoms | 19 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Symptoms Present and Unchanged | 27 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: New or Worsened Symptoms | 11 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:No Symptoms | 59 Participants |
| Placebo | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: No Symptoms | 30 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Symptoms Present and Unchanged | 5 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Improved Symptoms | 9 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Improved Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Improved Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: No Symptoms | 14 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:No Symptoms | 60 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Improved Symptoms | 12 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: No Symptoms | 69 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:No Symptoms | 68 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Improved Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:No Symptoms | 51 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Improved Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: No Symptoms | 68 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: No Symptoms | 67 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: No Symptoms | 66 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Improved Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:New or Worsened Symptoms | 3 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Improved Symptoms | 15 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Improved Symptoms | 3 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: No Symptoms | 69 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Improved Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Improved Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: No Symptoms | 43 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:No Symptoms | 62 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Improved Symptoms | 15 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: No Symptoms | 68 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Symptoms Present and Unchanged | 7 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: New or Worsened Symptoms | 4 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:No Symptoms | 68 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: No Symptoms | 65 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: New or Worsened Symptoms | 12 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Improved Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Improved Symptoms | 3 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Improved Symptoms | 2 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: New/Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Improved Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:No Symptoms | 59 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:No Symptoms | 69 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Improved Symptoms | 6 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Symptoms Present and Unchanged | 2 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Symptoms Present and Unchanged | 28 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Symptoms Present and Unchanged | 2 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:No Symptoms | 68 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Improved Symptoms | 7 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:No Symptoms | 69 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Improved Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability: No Symptoms | 58 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: No Symptoms | 66 Participants |
| JNJ-42847922 5 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Improved Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: No Symptoms | 66 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: No Symptoms | 41 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Improved Symptoms | 5 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:No Symptoms | 59 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: New or Worsened Symptoms | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:New or Worsened Symptoms | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Improved Symptoms | 19 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Improved Symptoms | 4 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:No Symptoms | 64 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:No Symptoms | 56 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:No Symptoms | 65 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Improved Symptoms | 9 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Symptoms Present and Unchanged | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Symptoms Present and Unchanged | 8 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: No Symptoms | 11 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Improved Symptoms | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: No Symptoms | 65 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: No Symptoms | 64 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:No Symptoms | 61 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:No Symptoms | 68 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: No Symptoms | 69 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Improved Symptoms | 4 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:No Symptoms | 66 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Improved Symptoms | 9 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:New or Worsened Symptoms | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Symptoms Present and Unchanged | 4 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Improved Symptoms | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:No Symptoms | 65 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: No Symptoms | 63 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: No Symptoms | 66 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Improved Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability: No Symptoms | 59 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Improved Symptoms | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: No Symptoms | 68 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: New or Worsened Symptoms | 14 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Improved Symptoms | 7 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Improved Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Improved Symptoms | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Improved Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Symptoms Present and Unchanged | 3 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: No Symptoms | 67 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Improved Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Symptoms Present and Unchanged | 32 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Improved Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Improved Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:No Symptoms | 66 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Improved Symptoms | 13 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Improved Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: New/Worsened Symptoms | 0 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Improved Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 10 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Symptoms Present and Unchanged | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:No Symptoms | 63 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Improved Symptoms | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:No Symptoms | 68 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Improved Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:No Symptoms | 56 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Improved Symptoms | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:No Symptoms | 65 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: No Symptoms | 63 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Improved Symptoms | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Improved Symptoms | 8 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: No Symptoms | 68 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Improved Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: No Symptoms | 67 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Improved Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: No Symptoms | 67 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Improved Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: No Symptoms | 62 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Improved Symptoms | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Symptoms Present and Unchanged | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability: No Symptoms | 60 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Improved Symptoms | 4 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Symptoms Present and Unchanged | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: No Symptoms | 65 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Improved Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: No Symptoms | 17 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Improved Symptoms | 11 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Symptoms Present and Unchanged | 28 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: New or Worsened Symptoms | 12 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: No Symptoms | 45 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Improved Symptoms | 8 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Symptoms Present and Unchanged | 9 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: New or Worsened Symptoms | 6 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: No Symptoms | 61 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Improved Symptoms | 5 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: New/Worsened Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:No Symptoms | 60 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Improved Symptoms | 5 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:New or Worsened Symptoms | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:No Symptoms | 65 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Improved Symptoms | 2 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:New or Worsened Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: No Symptoms | 68 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Improved Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:No Symptoms | 64 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Improved Symptoms | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:New or Worsened Symptoms | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:No Symptoms | 60 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Improved Symptoms | 7 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Symptoms Present and Unchanged | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:New or Worsened Symptoms | 3 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:No Symptoms | 67 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Improved Symptoms | 1 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Symptoms Present and Unchanged | 0 Participants |
| JNJ-42847922 20 mg | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:New or Worsened Symptoms | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: New or Worsened Symptoms | 17 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Symptoms Present and Unchanged | 21 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: Improved Symptoms | 15 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Improved Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: No Symptoms | 67 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Insomnia: No Symptoms | 16 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: New or Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:No Symptoms | 68 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Improved Symptoms | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: Improved Symptoms | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dysphoric Mood: No Symptoms | 66 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:New or Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Symptoms Present and Unchanged | 3 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability:Improved Symptoms | 9 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Irritability: No Symptoms | 58 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Symptoms Present and Unchanged | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Tremor: New or Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: New or Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness:Improved Symptoms | 5 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:No Symptoms | 53 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:No Symptoms | 60 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Anxiety-Nervousness: No Symptoms | 62 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: New or Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Symptoms Present and Unchanged | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Improved Symptoms | 7 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: Improved Symptoms | 4 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diarrhea: No Symptoms | 63 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: New or Worsened Symptoms | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Improved Symptoms | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness: Symptoms Present and Unchanged | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: Improved Symptoms | 5 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Nausea-Vomiting: No Symptoms | 63 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: New or Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Dizziness:New or Worsened Symptoms | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: Improved Symptoms | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Loss of Appetite: No Symptoms | 66 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:No Symptoms | 68 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:No Symptoms | 56 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Improved Symptoms | 6 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:Improved Symptoms | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Paresthesias:New or Worsened Symptoms | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: New or Worsened Symptoms | 4 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:Improved Symptoms | 3 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Symptoms Present and Unchanged | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: Improved Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | IASST: No Symptoms | 62 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:New or Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:Symptoms Present and Unchanged | 5 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:New or Worsened Symptoms | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Weakness:No Symptoms | 65 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:New or Worsened Symptoms | 6 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Derealization:Symptoms Present and Unchanged | 0 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:New or Worsened Symptoms | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Symptoms Present and Unchanged | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:Improved Symptoms | 7 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Remember:New or Worsened Symptoms | 5 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:No Symptoms | 64 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Restlessness:No Symptoms | 60 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: New/Worsened Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Symptoms Present and Unchanged | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:Improved Symptoms | 3 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Improved Symptoms | 2 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: Improved Symptoms | 5 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Poor Coordination: No Symptoms | 61 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: New or Worsened Symptoms | 6 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Stiffness:No Symptoms | 59 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:Symptoms Present and Unchanged | 1 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Symptoms Present and Unchanged | 5 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: Improved Symptoms | 14 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Fatigue: No Symptoms | 44 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Headaches:New or Worsened Symptoms | 7 Participants |
| Zolpidem | Number of Participants With Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17 | Diaphoresis:New or Worsened Symptoms | 2 Participants |
Secondary
Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14
PGI-I is a self-reported scale to measure improvement in illness using a 7-point scale ranging from 1 to 7, (1=very much improved, 2=much improved, 3=improved \[just enough to make a difference\], 4=no change, 5=worse \[just enough to make a difference\], 6=much worse, 7=very much worse). Negative changes in scores indicate improvement.
Time frame: Baseline and Day 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14 | 3.00 Units on a Scale | Full Range 0 |
| JNJ-42847922 5 mg | Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14 | 2.00 Units on a Scale | Full Range 0 |
| JNJ-42847922 10 mg | Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14 | 2.00 Units on a Scale | Full Range 0 |
| JNJ-42847922 20 mg | Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14 | 2.00 Units on a Scale | Full Range 0 |
| Zolpidem | Participant's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale Score on Day 14 | 2.00 Units on a Scale | Full Range 0 |
Secondary
Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case
Percentage of participants with remission of insomnia symptom defined as, total score of \<= 10 on ISI scale. ISI is 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. 5-point Likert scale (0-4) is used to rate each item. ISI total score is the sum of all item scores. ISI total score is the sum of all item scores. Scores are summed for a total score which ranges from 0-28 and interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28).
Time frame: Day 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Participants with missing values at a given time point are excluded from the frequency calculation for that time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 24.6 percentage of participants |
| JNJ-42847922 5 mg | Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 43.5 percentage of participants |
| JNJ-42847922 10 mg | Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 37.0 percentage of participants |
| JNJ-42847922 20 mg | Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 39.1 percentage of participants |
| Zolpidem | Percentage of Participants Who Achieved Remission Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 50.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case
Percentage of participants who achieved at least 50% reduction from baseline in ISI total score (responders) were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, Scores are summed for a total score which ranges from 0-28. Negative changes in scores indicate improvement. ISI total score is the sum of all item scores. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28).
Time frame: Day 14
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number participants evaluable for this outcome measure. Participants with missing values at a given time point were excluded from frequency calculation for that time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 23.2 percentage of participants |
| JNJ-42847922 5 mg | Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 42.0 percentage of participants |
| JNJ-42847922 10 mg | Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 31.5 percentage of participants |
| JNJ-42847922 20 mg | Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 34.8 percentage of participants |
| Zolpidem | Percentage of Participants Who Achieved Response Based on Insomnia Severity Index (ISI) Total Score on Day 14 - Observed Case | 42.9 percentage of participants |
Secondary
Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13
PSG was used to measure the sleep-onset REM in participants. REM sleep periods within 15 minutes from sleep onset were measured.
Time frame: Day 1 and 13
Population: FAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 13 | 1.4 percentage of participants |
| JNJ-42847922 5 mg | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 | 4.2 percentage of participants |
| JNJ-42847922 5 mg | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 13 | 2.9 percentage of participants |
| JNJ-42847922 10 mg | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 | 9.6 percentage of participants |
| JNJ-42847922 10 mg | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 13 | 4.1 percentage of participants |
| JNJ-42847922 20 mg | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 13 | 8.7 percentage of participants |
| JNJ-42847922 20 mg | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 | 14.1 percentage of participants |
| Zolpidem | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 1 | 0 percentage of participants |
| Zolpidem | Percentage of Participants With Sleep-Onset Rapid Eye Movement on Day 1 and 13 | Day 13 | 2.9 percentage of participants |
Secondary
Postural Stability Measured by Ataxiameter
The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway was measured using an ataxiameter. Participants were instructed to wear a pair of thin socks for each session. Before starting a measurement, participants were asked to stand still and comfortable, with their feet approximately 10 centimeters (cm) apart and their hands in a relaxed position alongside the body and eyes closed. The total period of body sway measurement was 2 minutes.
Time frame: Day 14 (morning)
Population: SAS included all participants who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure. One participant who was randomized to JNJ-42847922 10mg dose group received 5 mg of JNJ-42847922. This participant was summarized under the 5 mg dose group for safety analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Postural Stability Measured by Ataxiameter | -0.06 1/3 Degree Angle of Arc | Standard Deviation 17.15 |
| JNJ-42847922 5 mg | Postural Stability Measured by Ataxiameter | 3.14 1/3 Degree Angle of Arc | Standard Deviation 16.14 |
| JNJ-42847922 10 mg | Postural Stability Measured by Ataxiameter | -0.87 1/3 Degree Angle of Arc | Standard Deviation 15.62 |
| JNJ-42847922 20 mg | Postural Stability Measured by Ataxiameter | -0.25 1/3 Degree Angle of Arc | Standard Deviation 14.71 |
| Zolpidem | Postural Stability Measured by Ataxiameter | 1.65 1/3 Degree Angle of Arc | Standard Deviation 14.11 |