Sleep Disorders, Circadian Rhythm
Conditions
Keywords
Delayed sleep phase syndrome; drug therapy
Brief summary
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
Detailed description
Delayed sleep phase syndrome is the most common circadian disorder in adolescents and most adults with the condition report onset of symptoms during childhood or adolescence. Delayed Sleep Phase Syndrome involves a chronic mismatch between the usual daily schedule required by the individual's environment and his or her circadian sleep wake pattern. Individuals suffering from delayed Sleep Phase Syndrome experience great difficulty when attempting to fall asleep before 1-2 am, if not later, as well as rising at acceptable hours of the morning despite having completely normal sleep architecture and sleep duration. Delayed Sleep Phase Syndrome is a sleep disorder that results from a dysregulation of the circadian sleep-wake rhythm. Delayed Sleep Phase Syndrome is often the cause of severe insomnia and is associated with excessive daytime sleepiness, major depressive disorder and severe disruption of education, work and social functioning. Its major symptom is extreme difficulty initiating sleep at a conventional hour and waking on time in the morning for school or work. Ramelteon is a selective melatonin type 1 (MT1) and type 2 (MT2) receptor agonist. The purpose of this study is to evaluate the ability of ramelteon to advance the timing of sleep in individuals with delayed sleep phase syndrome. The effect of ramelteon will be analyzed based on collection of information from a post-sleep questionnaire completed by participants, and data collected by polysomnography in a sleep clinic setting. Total participation time involved in this study will be approximately 7 weeks.
Interventions
DRUGRamelteon
Ramelteon 1 mg, tablets, orally, once daily for up to two weeks.
DRUGPlacebo
Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females of childbearing potential who is sexually active must agree to use adequate contraception from screening throughout the duration of the study. * Must have a diagnosis of Delayed Sleep Phase Syndrome according to International Classification of Sleep Disorders criteria for at least 3 months. * Based on sleep history, subject's habitual sleep time is more than 3 hours later than the desired sleep time. * Must have had self reported insomnia which is defined per the sleep history as his or her sleep latency of at least 45 minutes when attempting to sleep at desired sleep time required by his or her work or school schedule. * The subjective sleep latency via Post sleep questionnaire during outpatient screening period must be greater than or equal to 45 minutes during every working night or school night provided the subject went to bed at their desired sleep time. * During single blind placebo run-in Polysomnography screening nights, subject is instructed to go to bed at their desired bed time and must demonstrate difficulty in falling asleep based on the following criteria: * During Polysomnography screening nights when the subject goes to bed at their desired sleep time or * The average of total wake time * Is in good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology. * Is able to complete self-rating scales via interactive voice response system, and has a touch tone phone. * Is willing to comply with study procedures and restrictions with fixed sleep time and wake time during the study and to attend regularly scheduled clinic visits as specified in this protocol. * Has a body mass index is between 18 and 34 kg/m2, inclusive. * Has a negative urine test result for selected substances of abuse (including alcohol). * Has a negative test result for hepatitis B surface antigen and hepatitis C virus antibody or history of human immunodeficiency virus. * Has not used pharmacological sleep assistance for more than 4 times/week during the 3 months prior to Initial Screening. * Must have discontinued use of all pharmacological sleep aids beginning 1 week prior to Visit 2 and for the duration of the trial.
Exclusion criteria
* Has a known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds or 5-hydroxytryptophan. * Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first dose of study medication, whichever is longer. * Has flown across greater than 3 time zones within the past 3 months prior to administration of study medication. * Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of study medication. * Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication. * Has a history of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, or regularly consumes more than 14 alcoholic drinks per week or consumes any alcoholic drinks within 24 hours of Screening Visit. * Has a history of drug abuse within the past 12 months. * Has a current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator. * Has a probable current diagnosis of another circadian rhythm disorder or a sleep disorder other than Delayed Sleep Phase Syndrome that is the primary cause of insomnia. * Had an apnea hypopnea index greater than 10 on the first night of Polysomnography Screening. * Has periodic limb movements during sleep with arousal index greater than 10 as seen on the first night of Polysomnography screening only. * Has a positive urine drug screen or breathalyzer test. * Has ever had a history of seizures; sleep apnea, restless leg syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening Polysomnography, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder. * Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months. * Smokes more than 3 cigarettes per day or uses tobacco products during nightly awakenings. * Routinely consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine per day. * Has used any central nervous system drug or other medications, including those used to treat psychiatric disorders, known to affect sleep/wake function within 1 week whichever is longer prior to the administration of single blind study drug. * Used melatonin, or other drugs/supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug) whichever is longer prior to the first dose of single blind medication. * Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: * Anxiolytics * Hypnotics * Antidepressants * Anticonvulsants * Sedating H1 antihistamines * Systemic steroids * Respiratory stimulants * Decongestants * Antipsychotics * Muscle relaxants * Over-the-counter and prescription diet aids * Narcotic analgesics * Beta Blockers * St. John's wort * Kava kava * Ginkgo biloba * Modafinil * Coumadin * Heparin * Melatonin and all other drugs or supplements known to affect sleep/wake function will be prohibited within 1 week of the first dose of study medication and during the entire study. * Has any clinically important abnormal finding as determined by a medical history, physical examination, Electrocardiogram, or clinical laboratory tests as determined by the investigator. * Has a positive hepatitis panel including anti- Hepatitis A Virus, hepatitis B surface antigen or anti- hepatitis C virus. * Has any additional condition(s) that in the investigator's opinion would: * Affect sleep/wake function * Prohibit the subject from completing the study, or * Not be in the best interest of the subject. * Exhibits a placebo response during single-blinded placebo run in period. * Individuals with a habitual sleep time later than 4:00 am should not be included in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7) | Nights 6-7 | The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | Nights 6-7 | The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep. |
| Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | Nights 13-14 | The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep. |
| Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7) | Nights 6-7 | The total sleep time divided by time-in-bed, multiplied by 100. |
| Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14) | Nights 13-14 | The total sleep time divided by time-in-bed, multiplied by 100. |
| Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7) | Nights 6-7 | The total sleep time divided by time-in-bed, multiplied by 100. |
| Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14) | Nights 13-14 | The total sleep time divided by time-in-bed, multiplied by 100. |
| Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7) | Nights 6-7 | The number of wake minutes after the onset of persistent sleep prior to the end of recording. |
| Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14) | Nights 13-14 | The number of wake minutes after the onset of persistent sleep prior to the end of recording. |
| Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7) | Nights 6-7 | The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted. |
| Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14) | Nights 13-14 | The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted. |
| Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | Nights 6-7 | The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording. |
| Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | Nights 13-14 | The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording. |
| Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | Nights 6-7 | Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | Nights 13-14 | Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | Nights 6-7 | Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | Nights 13-14 | Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Total Sleep Time Measured by Actigraphy (Nights 6-7) | Nights 6-7 | Total sleep time calculated using the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software. |
| Total Sleep Time Measured by Actigraphy (Nights 13-14) | Nights 13-14 | Total sleep time pertains to the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software. |
| Sleep Efficiency Measured by Actigraphy (Nights 6-7) | Nights 6-7 | Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100. |
| Sleep Efficiency Measured by Actigraphy (Nights 13-14) | Nights 13-14 | Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100. |
| Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7) | Nights 6-7 | Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes. |
| Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14) | Nights 13-14 | Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes. |
| Wake Bouts Measured by Actigraphy (Nights 6-7) | Nights 6-7 | The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval. |
| Wake Bouts Measured by Actigraphy (Nights 13-14) | Nights 13-14 | The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval. |
| Sleep Latency Measured by Actigraphy (Nights 6-7) | Nights 6-7 | The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject). |
| Sleep Latency Measured by Actigraphy (Nights 13-14) | Nights 13-14 | The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject). |
| Sleep Time Measured by Actigraphy (Nights 6-7) | Nights 6-7 | Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Sleep Time Measured by Actigraphy (Nights 13-14) | Nights 13-14 | Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Wake Time Measured by Actigraphy (Nights 6-7) | Nights 6-7 | Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Wake Time Measured by Actigraphy (Nights 13-14) | Nights 13-14 | Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long do you think it took you to fall asleep last night? |
| Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long do you think it took you to fall asleep last night? |
| Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long (total hours and minutes) do you think you slept last night? |
| Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long (total hours and minutes) do you think you slept last night? |
| Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, what is the total time you think you were awake? |
| Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, what is the total time you think you were awake? |
| Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, how many times do you think you woke up? |
| Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, how many times do you think you woke up? |
| Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe the quality of your sleep last night? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1. |
| Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe the quality of your sleep last night? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1. |
| Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, What time did you try to go to sleep last night? Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, What time did you try to go to sleep last night? Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, How easy was it for you to wake or get up in the morning when on a school or working night? was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1. |
| Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, How easy was it for you to wake or get up in the morning when on a school or working night? was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1. |
| Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your ability to concentrate this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1. |
| Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your ability to concentrate this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1. |
| Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7) | Nights 6-7 | Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your level of alertness this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1. |
| Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14) | Nights 13-14 | Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your level of alertness this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1. |
| Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test | Day 15 | The number of correct digit-for-number substitutions on a Digit Symbol Substitution Test in the 90-second period was recorded to assess psychomotor and cognitive function. The score was the average of 2 mornings' tests. Worst Value: 0. Best Value: No Limit. |
| Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate | Day 15 | After 16 words were read to a subject, a subject was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings' tests was calculated. |
| Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed | Day 15 | After 16 words were read to a subject, a subject waited 1 minute and then was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings' tests was calculated. |
| Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14) | Nights 13-14 | The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2). |
| Visual Analogue Scale for Feelings | Day 15 | Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value:0 mm.. Best Value:100 mm.. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood. |
| The Time of Dim Light Melatonin Secretion Onset | Day 15 | Linear Dim Light Melatonin Secretion Onset is defined as the first time of the evening (on a 24-hour clock) when the melatonin level rises above 3.0 pg/ml with a positive slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| The Time of Dim Light Melatonin Secretion Offset | Day 15 | Dim Light Melatonin Secretion Offset is defined as the first time of the morning (on a 24-hour clock) when the melatonin drops to below 3 pg/mL with a negative slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time. |
| The Total Duration of Secretion of Melatonin | Day 15 | The total duration of time from Dim Light Melatonin Secretion Onset to Dim Light Melatonin Secretion Offset. |
| The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours | Day 15 | Area under the concentration-time curve is a measure of total drug exposure. |
| Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period. | Day 15 | Average Cmax calculated as the average of three highest Cmax observations within the sampling period. |
| Visual Analogue Scale for Mood | Day 15 | Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value: 0 mm. Best Value: 100 mm. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood. |
Countries
United States
Participant flow
Recruitment details
Subjects enrolled at 47 sites in the United States from 10 October 2007 to 23 May 2008.
Pre-assignment details
Subjects were screened for 14 days, entered a 7-day placebo run-in, and then were randomized to once-daily (QD) treatment. To enter the double-blind randomization period, subjects must have met the eligible inclusion and none of the exclusion criteria and met sleep diagnostic criteria established during screening polysomnography.
Participants by arm
| Arm | Count |
|---|---|
| Ramelteon 1 mg QD Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks. | 32 |
| Ramelteon 4 mg QD Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks. | 33 |
| Ramelteon 8 mg QD Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks. | 35 |
| Placebo QD Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks. | 32 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Screening Period and Placebo Run-in | Adverse Event | 0 | 0 | 0 | 3 |
| Screening Period and Placebo Run-in | Did Not Meet Criteria | 0 | 0 | 0 | 322 |
| Screening Period and Placebo Run-in | Lost to Follow-up | 0 | 0 | 0 | 9 |
| Screening Period and Placebo Run-in | Study Termination | 0 | 0 | 0 | 15 |
| Screening Period and Placebo Run-in | Various | 0 | 0 | 0 | 25 |
| Screening Period and Placebo Run-in | Withdrawal by Subject | 0 | 0 | 0 | 43 |
| Treatment Period and Placebo Run-out | Lost to Follow-up | 2 | 1 | 2 | 0 |
| Treatment Period and Placebo Run-out | Protocol Violation | 0 | 0 | 1 | 1 |
| Treatment Period and Placebo Run-out | Various | 1 | 1 | 1 | 0 |
| Treatment Period and Placebo Run-out | Withdrawal by Subject | 0 | 0 | 1 | 3 |
Baseline characteristics
| Characteristic | Ramelteon 4 mg QD | Total | Placebo QD | Ramelteon 1 mg QD | Ramelteon 8 mg QD |
|---|---|---|---|---|---|
| Age Continuous | 33.7 years STANDARD_DEVIATION 12.31 | 31.4 years STANDARD_DEVIATION 11.19 | 33.1 years STANDARD_DEVIATION 13.08 | 29.6 years STANDARD_DEVIATION 9.36 | 29.3 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 75 Participants | 18 Participants | 19 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 57 Participants | 14 Participants | 13 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Pharmacologic sleep aid needed to sleep 0 | 30 subjects | 126 subjects | 32 subjects | 31 subjects | 33 subjects |
| Pharmacologic sleep aid needed to sleep 1 | 0 subjects | 1 subjects | 0 subjects | 0 subjects | 1 subjects |
| Pharmacologic sleep aid needed to sleep 2 | 2 subjects | 3 subjects | 0 subjects | 0 subjects | 1 subjects |
| Pharmacologic sleep aid needed to sleep 3 | 1 subjects | 2 subjects | 0 subjects | 1 subjects | 0 subjects |
| Pharmacologic sleep aid needed to sleep 4 | 0 subjects | 0 subjects | 0 subjects | 0 subjects | 0 subjects |
| Pharmacologic sleep aid needed to sleep >4 | 0 subjects | 0 subjects | 0 subjects | 0 subjects | 0 subjects |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 13 Participants | 3 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 114 Participants | 28 Participants | 24 Participants | 32 Participants |
| Sex: Female, Male Female | 17 Participants | 64 Participants | 12 Participants | 18 Participants | 17 Participants |
| Sex: Female, Male Male | 16 Participants | 68 Participants | 20 Participants | 14 Participants | 18 Participants |
| Time asleep (habitual and desired) Desired | 347.7 minutes STANDARD_DEVIATION 72.05 | 337.8 minutes STANDARD_DEVIATION 72.06 | 330.9 minutes STANDARD_DEVIATION 64.43 | 341.7 minutes STANDARD_DEVIATION 76.46 | 331.3 minutes STANDARD_DEVIATION 75.3 |
| Time asleep (habitual and desired) Habitual | 406.4 minutes STANDARD_DEVIATION 105.29 | 382.6 minutes STANDARD_DEVIATION 93.01 | 384.8 minutes STANDARD_DEVIATION 78.88 | 368.0 minutes STANDARD_DEVIATION 89.27 | 371.6 minutes STANDARD_DEVIATION 95.29 |
| Time to fall asleep (habitual and desired) Desired | 164.4 minutes STANDARD_DEVIATION 51.43 | 163.0 minutes STANDARD_DEVIATION 51.89 | 155.0 minutes STANDARD_DEVIATION 55.61 | 167.5 minutes STANDARD_DEVIATION 53.25 | 165.0 minutes STANDARD_DEVIATION 48.94 |
| Time to fall asleep (habitual and desired) Habitual | 76.8 minutes STANDARD_DEVIATION 59.89 | 80.2 minutes STANDARD_DEVIATION 65.66 | 69.8 minutes STANDARD_DEVIATION 58.72 | 83.0 minutes STANDARD_DEVIATION 78.85 | 90.4 minutes STANDARD_DEVIATION 64.79 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 32 | 5 / 33 | 6 / 35 | 4 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 | 0 / 35 | 0 / 32 |
Outcome results
Primary
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)
The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Time frame: Nights 6-7
Population: Analysis was conducted on the full analysis set (FAS), which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 59.30 minutes | Standard Error 6.684 |
| Ramelteon 4 mg QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 39.40 minutes | Standard Error 6.352 |
| Ramelteon 8 mg QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 55.94 minutes | Standard Error 6.482 |
| Placebo QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 55.12 minutes | Standard Error 6.871 |
Comparison: The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.p-value: 0.646ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.084ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.929ANCOVA
Secondary
Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period.
Average Cmax calculated as the average of three highest Cmax observations within the sampling period.
Time frame: Day 15
Population: The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period. | 75.3 μg/dL | Standard Error 5.12 |
| Ramelteon 4 mg QD | Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period. | 69.3 μg/dL | Standard Error 4.84 |
| Ramelteon 8 mg QD | Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period. | 65.2 μg/dL | Standard Error 4.77 |
| Placebo QD | Average Cmax (Maximum Observed Plasma Concentration) Calculated as the Average of Three Highest Cmax Observations Within the Sampling Period. | 79.2 μg/dL | Standard Error 5.46 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.589ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.156ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.041ANCOVA
Secondary
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)
The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 48.36 minutes | Standard Error 6.849 |
| Ramelteon 4 mg QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 38.61 minutes | Standard Error 6.611 |
| Ramelteon 8 mg QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 45.29 minutes | Standard Error 6.732 |
| Placebo QD | Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 46.64 minutes | Standard Error 6.983 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.854ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.383ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.883ANCOVA
Secondary
Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test
The number of correct digit-for-number substitutions on a Digit Symbol Substitution Test in the 90-second period was recorded to assess psychomotor and cognitive function. The score was the average of 2 mornings' tests. Worst Value: 0. Best Value: No Limit.
Time frame: Day 15
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test | 44.1 Scores on a scale | Standard Error 1.77 |
| Ramelteon 4 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test | 42.4 Scores on a scale | Standard Error 1.74 |
| Ramelteon 8 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test | 39.9 Scores on a scale | Standard Error 1.74 |
| Placebo QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Digit Symbol Substitution Test | 40.6 Scores on a scale | Standard Error 1.83 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.157ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.463ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.774ANCOVA
Secondary
Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed
After 16 words were read to a subject, a subject waited 1 minute and then was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings' tests was calculated.
Time frame: Day 15
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed | 6.5 score | Standard Error 0.51 |
| Ramelteon 4 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed | 5.9 score | Standard Error 0.51 |
| Ramelteon 8 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed | 6.7 score | Standard Error 0.5 |
| Placebo QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Delayed | 7.1 score | Standard Error 0.52 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.441ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.082ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.549ANCOVA
Secondary
Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate
After 16 words were read to a subject, a subject was given 2 minutes to write down as many words as he/she remembered. The correct number of words written was scored, and the average of 2 mornings' tests was calculated.
Time frame: Day 15
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate | 8.1 score | Standard Error 0.39 |
| Ramelteon 4 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate | 7.7 score | Standard Error 0.4 |
| Ramelteon 8 mg QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate | 8.6 score | Standard Error 0.39 |
| Placebo QD | Next Morning Residual Effects Assessments of Psychomotor and Cognitive Function Via Memory Recall Test--Immediate | 8.6 score | Standard Error 0.41 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.413ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.093ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.982ANCOVA
Secondary
Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14)
The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 8.08 number of awakenings | Standard Error 0.806 |
| Ramelteon 4 mg QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 9.33 number of awakenings | Standard Error 0.783 |
| Ramelteon 8 mg QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 9.87 number of awakenings | Standard Error 0.8 |
| Placebo QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 9.51 number of awakenings | Standard Error 0.822 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.197ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.871ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.737ANCOVA
Secondary
Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7)
The number of times after onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by stage 2, stage 3/4 non-REM (NREM) sleep, or REM sleep to be counted.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 9.22 number of awakenings | Standard Error 0.835 |
| Ramelteon 4 mg QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 10.79 number of awakenings | Standard Error 0.795 |
| Ramelteon 8 mg QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 10.79 number of awakenings | Standard Error 0.815 |
| Placebo QD | Number of Awakenings Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 9.67 number of awakenings | Standard Error 0.853 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.691ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.323ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.324ANCOVA
Secondary
Sleep Efficiency Measured by Actigraphy (Nights 13-14)
Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Efficiency Measured by Actigraphy (Nights 13-14) | 84.98 percentage of time asleep | Standard Error 1.349 |
| Ramelteon 4 mg QD | Sleep Efficiency Measured by Actigraphy (Nights 13-14) | 82.91 percentage of time asleep | Standard Error 1.381 |
| Ramelteon 8 mg QD | Sleep Efficiency Measured by Actigraphy (Nights 13-14) | 81.31 percentage of time asleep | Standard Error 1.3 |
| Placebo QD | Sleep Efficiency Measured by Actigraphy (Nights 13-14) | 83.24 percentage of time asleep | Standard Error 1.388 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.352ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.86ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.297ANCOVA
Secondary
Sleep Efficiency Measured by Actigraphy (Nights 6-7)
Sleep efficiency pertains to the scored total sleep time (recorded by actigraphy watch worn by subject) of the sleep interval divided by total time in bed minus total invalid time (Sleep/Wake), multiplied by 100.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Efficiency Measured by Actigraphy (Nights 6-7) | 85.79 percentage of time asleep | Standard Error 1.117 |
| Ramelteon 4 mg QD | Sleep Efficiency Measured by Actigraphy (Nights 6-7) | 83.46 percentage of time asleep | Standard Error 1.086 |
| Ramelteon 8 mg QD | Sleep Efficiency Measured by Actigraphy (Nights 6-7) | 81.38 percentage of time asleep | Standard Error 1.081 |
| Placebo QD | Sleep Efficiency Measured by Actigraphy (Nights 6-7) | 82.72 percentage of time asleep | Standard Error 1.089 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.04ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.61ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.368ANCOVA
Secondary
Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)
The total sleep time divided by time-in-bed, multiplied by 100.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14) | 69.07 percentage of time asleep | Standard Error 3.244 |
| Ramelteon 4 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14) | 75.13 percentage of time asleep | Standard Error 3.126 |
| Ramelteon 8 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14) | 70.19 percentage of time asleep | Standard Error 3.181 |
| Placebo QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14) | 70.99 percentage of time asleep | Standard Error 3.286 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.661ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.341ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.853ANCOVA
Secondary
Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)
The total sleep time divided by time-in-bed, multiplied by 100.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7) | 64.49 percentage of time asleep | Standard Error 3.385 |
| Ramelteon 4 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7) | 71.83 percentage of time asleep | Standard Error 3.213 |
| Ramelteon 8 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7) | 65.70 percentage of time asleep | Standard Error 3.272 |
| Placebo QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7) | 64.64 percentage of time asleep | Standard Error 3.46 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.973ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.117ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.816ANCOVA
Secondary
Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14)
The total sleep time divided by time-in-bed, multiplied by 100.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14) | 81.09 percentage of time asleep | Standard Error 1.706 |
| Ramelteon 4 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14) | 79.33 percentage of time asleep | Standard Error 1.671 |
| Ramelteon 8 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14) | 78.92 percentage of time asleep | Standard Error 1.702 |
| Placebo QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 13-14) | 80.80 percentage of time asleep | Standard Error 1.745 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.9ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.525ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.418ANCOVA
Secondary
Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7)
The total sleep time divided by time-in-bed, multiplied by 100.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7) | 78.42 percentage of time asleep | Standard Error 1.701 |
| Ramelteon 4 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7) | 79.90 percentage of time asleep | Standard Error 1.642 |
| Ramelteon 8 mg QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7) | 78.89 percentage of time asleep | Standard Error 1.675 |
| Placebo QD | Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-8 Hours) (Nights 6-7) | 76.30 percentage of time asleep | Standard Error 1.756 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.365ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.121ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.268ANCOVA
Secondary
Sleep Latency Measured by Actigraphy (Nights 13-14)
The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Latency Measured by Actigraphy (Nights 13-14) | 12.10 minutes | Standard Error 6.145 |
| Ramelteon 4 mg QD | Sleep Latency Measured by Actigraphy (Nights 13-14) | 16.40 minutes | Standard Error 6.46 |
| Ramelteon 8 mg QD | Sleep Latency Measured by Actigraphy (Nights 13-14) | 25.43 minutes | Standard Error 5.859 |
| Placebo QD | Sleep Latency Measured by Actigraphy (Nights 13-14) | 12.36 minutes | Standard Error 6.169 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.975ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.639ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.109ANCOVA
Secondary
Sleep Latency Measured by Actigraphy (Nights 6-7)
The elapsed time from the beginning of the recording to the onset of the first 10 minutes of continuous sleep (recorded by actigraphy watch worn by subject).
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Latency Measured by Actigraphy (Nights 6-7) | 12.53 minutes | Standard Error 3.292 |
| Ramelteon 4 mg QD | Sleep Latency Measured by Actigraphy (Nights 6-7) | 18.05 minutes | Standard Error 3.28 |
| Ramelteon 8 mg QD | Sleep Latency Measured by Actigraphy (Nights 6-7) | 25.00 minutes | Standard Error 3.156 |
| Placebo QD | Sleep Latency Measured by Actigraphy (Nights 6-7) | 12.42 minutes | Standard Error 3.129 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.979ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.194ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.004ANCOVA
Secondary
Sleep Time Measured by Actigraphy (Nights 13-14)
Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Time Measured by Actigraphy (Nights 13-14) | 22.83 hours on a 24-hour clock | Standard Error 0.15 |
| Ramelteon 4 mg QD | Sleep Time Measured by Actigraphy (Nights 13-14) | 22.71 hours on a 24-hour clock | Standard Error 0.166 |
| Ramelteon 8 mg QD | Sleep Time Measured by Actigraphy (Nights 13-14) | 23.11 hours on a 24-hour clock | Standard Error 0.15 |
| Placebo QD | Sleep Time Measured by Actigraphy (Nights 13-14) | 23.18 hours on a 24-hour clock | Standard Error 0.15 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.092ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.025ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.732ANCOVA
Secondary
Sleep Time Measured by Actigraphy (Nights 6-7)
Clock time subject goes to sleep (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Time Measured by Actigraphy (Nights 6-7) | 23.28 hours on a 24-hour clock | Standard Error 0.15 |
| Ramelteon 4 mg QD | Sleep Time Measured by Actigraphy (Nights 6-7) | 22.75 hours on a 24-hour clock | Standard Error 0.15 |
| Ramelteon 8 mg QD | Sleep Time Measured by Actigraphy (Nights 6-7) | 23.11 hours on a 24-hour clock | Standard Error 0.15 |
| Placebo QD | Sleep Time Measured by Actigraphy (Nights 6-7) | 23.31 hours on a 24-hour clock | Standard Error 0.15 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.823ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.004ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.296ANCOVA
Secondary
Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 22.36 hours on a 24-hour clock | Standard Error 0.016 |
| Ramelteon 4 mg QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 22.36 hours on a 24-hour clock | Standard Error 0.016 |
| Ramelteon 8 mg QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 22.36 hours on a 24-hour clock | Standard Error 0.016 |
| Placebo QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 22.33 hours on a 24-hour clock | Standard Error 0.016 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.194ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.134ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.13ANCOVA
Secondary
Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Sleep time was measured as the clock time the subject went to sleep. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 22.40 hours on a 24-hour clock | Standard Error 0.016 |
| Ramelteon 4 mg QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 22.36 hours on a 24-hour clock | Standard Error 0.016 |
| Ramelteon 8 mg QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 22.35 hours on a 24-hour clock | Standard Error 0.016 |
| Placebo QD | Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 22.35 hours on a 24-hour clock | Standard Error 0.033 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.206ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.495ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.8ANCOVA
Secondary
Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your ability to concentrate this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 3.77 scores on a scale | Standard Error 0.164 |
| Ramelteon 4 mg QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.17 scores on a scale | Standard Error 0.164 |
| Ramelteon 8 mg QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.01 scores on a scale | Standard Error 0.159 |
| Placebo QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.01 scores on a scale | Standard Error 0.164 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.294ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.474ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.999ANCOVA
Secondary
Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective ability to concentrate was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your ability to concentrate this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.31 scores on a scale | Standard Error 0.155 |
| Ramelteon 4 mg QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.30 scores on a scale | Standard Error 0.151 |
| Ramelteon 8 mg QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.40 scores on a scale | Standard Error 0.148 |
| Placebo QD | Subjective Ability to Concentrate in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.48 scores on a scale | Standard Error 0.159 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.425ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.406ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.72ANCOVA
Secondary
Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14)
The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, How easy was it for you to wake or get up in the morning when on a school or working night? was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.46 scores on a scale | Standard Error 0.219 |
| Ramelteon 4 mg QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.66 scores on a scale | Standard Error 0.217 |
| Ramelteon 8 mg QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.30 scores on a scale | Standard Error 0.191 |
| Placebo QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.28 scores on a scale | Standard Error 0.198 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.519ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.179ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.935ANCOVA
Secondary
Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7)
The score was an average of 2 nights responses. If subjects had a work or school day, the answer to, How easy was it for you to wake or get up in the morning when on a school or working night? was based on the following scale: Extremely Difficult =7; Very Difficult =6; Difficult =5; Neither =4; Easy =3; Very Easy =2; Extremely Easy =1.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.68 scores on a scale | Standard Error 0.224 |
| Ramelteon 4 mg QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.76 scores on a scale | Standard Error 0.202 |
| Ramelteon 8 mg QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.67 scores on a scale | Standard Error 0.178 |
| Placebo QD | Subjective Getting up in the Morning Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.88 scores on a scale | Standard Error 0.203 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.498ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.664ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.428ANCOVA
Secondary
Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your level of alertness this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.02 scores on a scale | Standard Error 0.181 |
| Ramelteon 4 mg QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.32 scores on a scale | Standard Error 0.181 |
| Ramelteon 8 mg QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14) | 3.99 scores on a scale | Standard Error 0.176 |
| Placebo QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.12 scores on a scale | Standard Error 0.182 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.684ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.399ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.611ANCOVA
Secondary
Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective level of alertness was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe your level of alertness this morning? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.43 scores on a scale | Standard Error 0.158 |
| Ramelteon 4 mg QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.32 scores on a scale | Standard Error 0.155 |
| Ramelteon 8 mg QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.33 scores on a scale | Standard Error 0.152 |
| Placebo QD | Subjective Level of Alertness Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.53 scores on a scale | Standard Error 0.163 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.655ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.331ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.362ANCOVA
Secondary
Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, how many times do you think you woke up?
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14) | 2.94 number of awakenings | Standard Error 0.456 |
| Ramelteon 4 mg QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14) | 3.72 number of awakenings | Standard Error 0.427 |
| Ramelteon 8 mg QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14) | 3.33 number of awakenings | Standard Error 0.443 |
| Placebo QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 13-14) | 3.04 number of awakenings | Standard Error 0.423 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.867ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.244ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.62ANCOVA
Secondary
Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective number of awakenings was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, how many times do you think you woke up?
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7) | 2.68 number of awakenings | Standard Error 0.364 |
| Ramelteon 4 mg QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7) | 3.72 number of awakenings | Standard Error 0.382 |
| Ramelteon 8 mg QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7) | 2.92 number of awakenings | Standard Error 0.385 |
| Placebo QD | Subjective Number of Awakenings Measured by a Post-sleep Questionnaire (Nights 6-7) | 3.23 number of awakenings | Standard Error 0.383 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.284ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.344ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.558ANCOVA
Secondary
Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long do you think it took you to fall asleep last night?
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14) | 80.57 minutes | Standard Error 7.406 |
| Ramelteon 4 mg QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14) | 69.40 minutes | Standard Error 7.423 |
| Ramelteon 8 mg QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14) | 77.29 minutes | Standard Error 7.178 |
| Placebo QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 13-14) | 74.75 minutes | Standard Error 7.407 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.561ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.595ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.795ANCOVA
Secondary
Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective sleep latency was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long do you think it took you to fall asleep last night?
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7) | 103.55 minutes | Standard Error 8.301 |
| Ramelteon 4 mg QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7) | 84.46 minutes | Standard Error 8.087 |
| Ramelteon 8 mg QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7) | 92.79 minutes | Standard Error 7.93 |
| Placebo QD | Subjective Sleep Latency Measured by a Post-sleep Questionnaire (Nights 6-7) | 97.28 minutes | Standard Error 8.491 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.581ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.257ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.688ANCOVA
Secondary
Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe the quality of your sleep last night? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.27 scores on a scale | Standard Error 0.184 |
| Ramelteon 4 mg QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.35 scores on a scale | Standard Error 0.185 |
| Ramelteon 8 mg QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.03 scores on a scale | Standard Error 0.179 |
| Placebo QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 13-14) | 4.20 scores on a scale | Standard Error 0.184 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.796ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.546ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.479ANCOVA
Secondary
Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective sleep quality was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How would you describe the quality of your sleep last night? Scores were based on the following scale: Extremely Poor=7; Very Poor=6; Poor=5; Fair=4; Good=3; Very Good=2; Excellent=1.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.45 scores on a scale | Standard Error 0.169 |
| Ramelteon 4 mg QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.61 scores on a scale | Standard Error 0.166 |
| Ramelteon 8 mg QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.33 scores on a scale | Standard Error 0.162 |
| Placebo QD | Subjective Sleep Quality Measured by a Post-sleep Questionnaire (Nights 6-7) | 4.74 scores on a scale | Standard Error 0.173 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.206ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.559ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.074ANCOVA
Secondary
Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, What time did you try to go to sleep last night? Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 10.36 hours on a 24-hour clock | Standard Error 0.066 |
| Ramelteon 4 mg QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 10.30 hours on a 24-hour clock | Standard Error 0.066 |
| Ramelteon 8 mg QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 10.36 hours on a 24-hour clock | Standard Error 0.066 |
| Placebo QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 10.40 hours on a 24-hour clock | Standard Error 0.066 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.722ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.262ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.717ANCOVA
Secondary
Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, What time did you try to go to sleep last night? Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 10.36 hours on a 24-hour clock | Standard Error 0.066 |
| Ramelteon 4 mg QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 10.41 hours on a 24-hour clock | Standard Error 0.066 |
| Ramelteon 8 mg QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 10.40 hours on a 24-hour clock | Standard Error 0.066 |
| Placebo QD | Subjective Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 10.40 hours on a 24-hour clock | Standard Error 0.066 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.766ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.912ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.952ANCOVA
Secondary
Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long (total hours and minutes) do you think you slept last night?
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 379.20 minutes | Standard Error 10.49 |
| Ramelteon 4 mg QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 375.73 minutes | Standard Error 10.532 |
| Ramelteon 8 mg QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 365.14 minutes | Standard Error 10.229 |
| Placebo QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 13-14) | 368.99 minutes | Standard Error 10.513 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.475ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.635ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.782ANCOVA
Secondary
Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective total sleep time was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, How long (total hours and minutes) do you think you slept last night?
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 348.10 minutes | Standard Error 10.302 |
| Ramelteon 4 mg QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 370.14 minutes | Standard Error 10.067 |
| Ramelteon 8 mg QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 360.57 minutes | Standard Error 9.883 |
| Placebo QD | Subjective Total Sleep Time Measured by a Post-sleep Questionnaire (Nights 6-7) | 341.76 minutes | Standard Error 10.571 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.655ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.177ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.044ANCOVA
Secondary
Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14)
Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, what is the total time you think you were awake?
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14) | 23.49 minutes | Standard Error 5.882 |
| Ramelteon 4 mg QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14) | 45.54 minutes | Standard Error 5.877 |
| Ramelteon 8 mg QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14) | 28.66 minutes | Standard Error 5.669 |
| Placebo QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 13-14) | 30.52 minutes | Standard Error 5.794 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.057ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.379ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.808ANCOVA
Secondary
Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7)
Subjective wake time after sleep onset was an average of 2 nights responses and measured by post-sleep questionnaire in response to the question, Did you wake up during the night? If yes, what is the total time you think you were awake?
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7) | 35.15 minutes | Standard Error 7.084 |
| Ramelteon 4 mg QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7) | 52.52 minutes | Standard Error 6.671 |
| Ramelteon 8 mg QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7) | 34.41 minutes | Standard Error 6.659 |
| Placebo QD | Subjective Wake Time After Sleep Onset Measured by a Post-sleep Questionnaire (Nights 6-7) | 47.84 minutes | Standard Error 7.1 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.192ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.618ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.152ANCOVA
Secondary
The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours
Area under the concentration-time curve is a measure of total drug exposure.
Time frame: Day 15
Population: The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours | 608.5 μg/dL/hour | Standard Error 40.13 |
| Ramelteon 4 mg QD | The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours | 563.3 μg/dL/hour | Standard Error 38.08 |
| Ramelteon 8 mg QD | The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours | 528.3 μg/dL/hour | Standard Error 37.35 |
| Placebo QD | The Area Under the Concentration-time Curve of Melatonin From 0 to 24 Hours | 631.5 μg/dL/hour | Standard Error 42.77 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.685ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.214ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.055ANCOVA
Secondary
The Time of Dim Light Melatonin Secretion Offset
Dim Light Melatonin Secretion Offset is defined as the first time of the morning (on a 24-hour clock) when the melatonin drops to below 3 pg/mL with a negative slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Day 15
Population: The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | The Time of Dim Light Melatonin Secretion Offset | 11.21 hours on a 24-hour clock | Standard Error 0.25 |
| Ramelteon 4 mg QD | The Time of Dim Light Melatonin Secretion Offset | 10.73 hours on a 24-hour clock | Standard Error 0.25 |
| Ramelteon 8 mg QD | The Time of Dim Light Melatonin Secretion Offset | 10.96 hours on a 24-hour clock | Standard Error 0.25 |
| Placebo QD | The Time of Dim Light Melatonin Secretion Offset | 10.85 hours on a 24-hour clock | Standard Error 0.283 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.307ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.765ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.727ANCOVA
Secondary
The Time of Dim Light Melatonin Secretion Onset
Linear Dim Light Melatonin Secretion Onset is defined as the first time of the evening (on a 24-hour clock) when the melatonin level rises above 3.0 pg/ml with a positive slope. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Day 15
Population: The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | The Time of Dim Light Melatonin Secretion Onset | 21.40 hours on a 24-hour clock | Standard Error 0.183 |
| Ramelteon 4 mg QD | The Time of Dim Light Melatonin Secretion Onset | 21.30 hours on a 24-hour clock | Standard Error 0.166 |
| Ramelteon 8 mg QD | The Time of Dim Light Melatonin Secretion Onset | 20.93 hours on a 24-hour clock | Standard Error 0.166 |
| Placebo QD | The Time of Dim Light Melatonin Secretion Onset | 21.21 hours on a 24-hour clock | Standard Error 0.2 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.513ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.751ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.242ANCOVA
Secondary
The Total Duration of Secretion of Melatonin
The total duration of time from Dim Light Melatonin Secretion Onset to Dim Light Melatonin Secretion Offset.
Time frame: Day 15
Population: The melatonin set included all subjects who had saliva samples collected under dim light conditions for melatonin measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | The Total Duration of Secretion of Melatonin | 1021.8 minutes | Standard Error 34.13 |
| Ramelteon 4 mg QD | The Total Duration of Secretion of Melatonin | 1003.1 minutes | Standard Error 31.98 |
| Ramelteon 8 mg QD | The Total Duration of Secretion of Melatonin | 980.2 minutes | Standard Error 31.43 |
| Placebo QD | The Total Duration of Secretion of Melatonin | 1027.9 minutes | Standard Error 36.39 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.902ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.59ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.29ANCOVA
Secondary
Total Sleep Time Measured by Actigraphy (Nights 13-14)
Total sleep time pertains to the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Total Sleep Time Measured by Actigraphy (Nights 13-14) | 391.61 minutes | Standard Error 8.661 |
| Ramelteon 4 mg QD | Total Sleep Time Measured by Actigraphy (Nights 13-14) | 390.76 minutes | Standard Error 8.982 |
| Ramelteon 8 mg QD | Total Sleep Time Measured by Actigraphy (Nights 13-14) | 370.80 minutes | Standard Error 8.228 |
| Placebo QD | Total Sleep Time Measured by Actigraphy (Nights 13-14) | 378.91 minutes | Standard Error 8.845 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.286ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.318ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.483ANCOVA
Secondary
Total Sleep Time Measured by Actigraphy (Nights 6-7)
Total sleep time calculated using the total number of epochs (number of movements recorded by actigraphy watch worn by subject) that are less than or equal to 40, measured between the start time and end time during the nocturnal sleep interval, scored as SLEEP by the actigraphy software.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Total Sleep Time Measured by Actigraphy (Nights 6-7) | 374.37 minutes | Standard Error 8.741 |
| Ramelteon 4 mg QD | Total Sleep Time Measured by Actigraphy (Nights 6-7) | 393.37 minutes | Standard Error 8.632 |
| Ramelteon 8 mg QD | Total Sleep Time Measured by Actigraphy (Nights 6-7) | 370.83 minutes | Standard Error 8.352 |
| Placebo QD | Total Sleep Time Measured by Actigraphy (Nights 6-7) | 369.05 minutes | Standard Error 8.457 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.643ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.032ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.875ANCOVA
Secondary
Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 389.72 minutes | Standard Error 8.866 |
| Ramelteon 4 mg QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 378.04 minutes | Standard Error 8.683 |
| Ramelteon 8 mg QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 379.17 minutes | Standard Error 8.843 |
| Placebo QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 388.51 minutes | Standard Error 9.064 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.92ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.382ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.439ANCOVA
Secondary
Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 376.41 minutes | Standard Error 8.158 |
| Ramelteon 4 mg QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 383.51 minutes | Standard Error 7.876 |
| Ramelteon 8 mg QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 378.62 minutes | Standard Error 8.033 |
| Placebo QD | Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 366.23 minutes | Standard Error 8.421 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.365ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.121ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.269ANCOVA
Secondary
Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 55.69 minutes | Standard Error 5.841 |
| Ramelteon 4 mg QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 44.68 minutes | Standard Error 5.629 |
| Ramelteon 8 mg QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 53.64 minutes | Standard Error 5.728 |
| Placebo QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 52.19 minutes | Standard Error 5.918 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.659ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.337ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.853ANCOVA
Secondary
Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
The sum of all the minutes of Stage Wake from the beginning of the recording to the end of recording.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 63.92 minutes | Standard Error 6.096 |
| Ramelteon 4 mg QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 50.67 minutes | Standard Error 5.785 |
| Ramelteon 8 mg QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 61.67 minutes | Standard Error 5.892 |
| Placebo QD | Total Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 63.63 minutes | Standard Error 6.23 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.972ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.117ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.811ANCOVA
Secondary
Visual Analogue Scale for Feelings
Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value:0 mm.. Best Value:100 mm.. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.
Time frame: Day 15
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Visual Analogue Scale for Feelings | 37.3 Units on a scale | Standard Error 1.52 |
| Ramelteon 4 mg QD | Visual Analogue Scale for Feelings | 34.8 Units on a scale | Standard Error 1.5 |
| Ramelteon 8 mg QD | Visual Analogue Scale for Feelings | 36.8 Units on a scale | Standard Error 1.5 |
| Placebo QD | Visual Analogue Scale for Feelings | 36.9 Units on a scale | Standard Error 1.57 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.837ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.321ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.978ANCOVA
Secondary
Visual Analogue Scale for Mood
Subjects marked visual scales (in millimeters) that represented ranges of emotions (eg, calm to anxious; normal to bloated; energetic to fatigued). Individual subject composite scores were calculated, and the average of 2 tests were analyzed. Worst Value: 0 mm. Best Value: 100 mm. The farther to the left a subject marks, the better their mood; farther to the right, the more distressed the mood. Higher numbers indicate a more distressed mood.
Time frame: Day 15
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Visual Analogue Scale for Mood | 34.2 Units on a scale | Standard Error 3.2 |
| Ramelteon 4 mg QD | Visual Analogue Scale for Mood | 33.4 Units on a scale | Standard Error 3.15 |
| Ramelteon 8 mg QD | Visual Analogue Scale for Mood | 34.3 Units on a scale | Standard Error 3.17 |
| Placebo QD | Visual Analogue Scale for Mood | 33.4 Units on a scale | Standard Error 3.31 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.86ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.997ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.834ANCOVA
Secondary
Wake Bouts Measured by Actigraphy (Nights 13-14)
The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Bouts Measured by Actigraphy (Nights 13-14) | 23.42 wake bouts | Standard Error 1.201 |
| Ramelteon 4 mg QD | Wake Bouts Measured by Actigraphy (Nights 13-14) | 24.21 wake bouts | Standard Error 1.23 |
| Ramelteon 8 mg QD | Wake Bouts Measured by Actigraphy (Nights 13-14) | 23.52 wake bouts | Standard Error 1.146 |
| Placebo QD | Wake Bouts Measured by Actigraphy (Nights 13-14) | 22.78 wake bouts | Standard Error 1.206 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.698ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.385ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.641ANCOVA
Secondary
Wake Bouts Measured by Actigraphy (Nights 6-7)
The number of wake bouts pertains to the total number of continuous blocks (recorded by actigraphy watch worn by subject), with one or more epochs in duration, and with each epoch of each clock scored as WAKE between the start time and the end time of the given interval.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Bouts Measured by Actigraphy (Nights 6-7) | 20.98 wake bouts | Standard Error 1.518 |
| Ramelteon 4 mg QD | Wake Bouts Measured by Actigraphy (Nights 6-7) | 22.91 wake bouts | Standard Error 1.476 |
| Ramelteon 8 mg QD | Wake Bouts Measured by Actigraphy (Nights 6-7) | 23.32 wake bouts | Standard Error 1.457 |
| Placebo QD | Wake Bouts Measured by Actigraphy (Nights 6-7) | 22.82 wake bouts | Standard Error 1.442 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.356ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.964ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.799ANCOVA
Secondary
Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14)
The number of wake minutes after the onset of persistent sleep prior to the end of recording.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 43.36 minutes | Standard Error 6.124 |
| Ramelteon 4 mg QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 63.47 minutes | Standard Error 6.032 |
| Ramelteon 8 mg QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 59.77 minutes | Standard Error 6.103 |
| Placebo QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 48.88 minutes | Standard Error 6.24 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.511ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.082ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.188ANCOVA
Secondary
Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7)
The number of wake minutes after the onset of persistent sleep prior to the end of recording.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 46.26 minutes | Standard Error 5.88 |
| Ramelteon 4 mg QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 62.86 minutes | Standard Error 5.704 |
| Ramelteon 8 mg QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 51.06 minutes | Standard Error 5.758 |
| Placebo QD | Wake Time After Sleep Onset Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 62.11 minutes | Standard Error 6.035 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.051ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.926ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.166ANCOVA
Secondary
Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14)
Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14) | 48.11 minutes | Standard Error 4.074 |
| Ramelteon 4 mg QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14) | 54.72 minutes | Standard Error 4.185 |
| Ramelteon 8 mg QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14) | 52.36 minutes | Standard Error 3.874 |
| Placebo QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 13-14) | 51.32 minutes | Standard Error 4.14 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.566ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.543ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.847ANCOVA
Secondary
Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7)
Wake time during sleep is the total number of epochs (number of movements recorded by actigraphy watch worn by subject) between the start time and the end time of the given sleep interval, scored as WAKE by the software (or manually set as WAKE by the practitioner using the software), multiplied by the Epoch length in minutes.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7) | 41.81 minutes | Standard Error 4.404 |
| Ramelteon 4 mg QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7) | 51.98 minutes | Standard Error 4.298 |
| Ramelteon 8 mg QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7) | 54.70 minutes | Standard Error 4.211 |
| Placebo QD | Wake Time During Sleep Interval Measured by Actigraphy (Nights 6-7) | 53.14 minutes | Standard Error 4.223 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.053ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.837ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.783ANCOVA
Secondary
Wake Time Measured by Actigraphy (Nights 13-14)
Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time Measured by Actigraphy (Nights 13-14) | 06.13 hours on a 24-hour clock | Standard Error 0.133 |
| Ramelteon 4 mg QD | Wake Time Measured by Actigraphy (Nights 13-14) | 06.08 hours on a 24-hour clock | Standard Error 0.133 |
| Ramelteon 8 mg QD | Wake Time Measured by Actigraphy (Nights 13-14) | 06.16 hours on a 24-hour clock | Standard Error 0.133 |
| Placebo QD | Wake Time Measured by Actigraphy (Nights 13-14) | 06.30 hours on a 24-hour clock | Standard Error 0.133 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.349ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.203ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.444ANCOVA
Secondary
Wake Time Measured by Actigraphy (Nights 6-7)
Clock time subject wakes up (recorded by actigraphy watch worn by subject). Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time Measured by Actigraphy (Nights 6-7) | 06.20 hours on a 24-hour clock | Standard Error 0.116 |
| Ramelteon 4 mg QD | Wake Time Measured by Actigraphy (Nights 6-7) | 06.18 hours on a 24-hour clock | Standard Error 0.116 |
| Ramelteon 8 mg QD | Wake Time Measured by Actigraphy (Nights 6-7) | 06.23 hours on a 24-hour clock | Standard Error 0.116 |
| Placebo QD | Wake Time Measured by Actigraphy (Nights 6-7) | 06.36 hours on a 24-hour clock | Standard Error 0.116 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.298ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.276ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.43ANCOVA
Secondary
Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 13-14
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 06.31 hours on a 24-hour clock | Standard Error 0.066 |
| Ramelteon 4 mg QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 06.21 hours on a 24-hour clock | Standard Error 0.066 |
| Ramelteon 8 mg QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 06.40 hours on a 24-hour clock | Standard Error 0.066 |
| Placebo QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) | 06.26 hours on a 24-hour clock | Standard Error 0.083 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.675ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.566ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.205ANCOVA
Secondary
Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Wake Time was measured as the clock time that the subject got up in the morning. Units are hours and minutes on a 24-hour clock, expressed in decimal time.
Time frame: Nights 6-7
Population: Analysis was conducted on the FAS, which consisted of all randomized subjects who had at least a baseline assessment and 1 post-baseline assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ramelteon 1 mg QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 06.35 hours on a 24-hour clock | Standard Error 0.033 |
| Ramelteon 4 mg QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 06.31 hours on a 24-hour clock | Standard Error 0.033 |
| Ramelteon 8 mg QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 06.30 hours on a 24-hour clock | Standard Error 0.033 |
| Placebo QD | Wake Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) | 06.26 hours on a 24-hour clock | Standard Error 0.033 |
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.063ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.156ANCOVA
Comparison: The comparison between the 2 treatment groups was made using the ANCOVA model.p-value: 0.521ANCOVA