Primary Insomnia, Secondary Insomnia
Conditions
Brief summary
The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.
Detailed description
Outpatients with chronic insomnia who participate in this study will be treated in each of four 2-week treatment periods with bedtime doses of either placebo, zolpidem, LY2624803 1 mg, or LY2624803 3 mg. Neither patients nor investigators will be told what treatments are being given in any treatment period. A patient who completes all four treatment periods will be treated with placebo in 1, 2, or 3 of the periods; with zolpidem in 0, 1, or 2 of the periods; and with LY2624803 in either 1 or 2 of the periods. No patient will receive placebo for all four of the 2-week treatment periods. All patients will receive LY2624803 for at least one of the four 2-week treatment periods. During each treatment period, patients will record information each morning about their sleep the night before, and each evening about their functioning since waking up. Patients will also wear wrist actigraphy devices to record their physical activity. At the conclusion of each treatment period, patients will answer questions about their sleep, functioning, health, and relative preference for treatments.
Interventions
DRUGLY2624803
1 mg, oral capsule, once nightly before bedtime
DRUGPlacebo
matching placebo (capsule or tablet), once nightly before bedtime
DRUGzolpidem
5 or 10 mg, oral tablet, once nightly before bedtime
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients must be between 18 and 85 years of age, with a stable living situation * Clinical diagnosis of either primary insomnia or secondary insomnia (comorbid with depression, anxiety, and/or medical illness) * Insomnia systems must be at least moderate in severity within the month prior to study entry, and must include difficulty staying asleep and/or problems with awakening earlier than desired * Psychiatric and medical conditions present must be stable over the 3 months prior to study entry, and not expected to worsen significantly or require hospitalization during participation in the study * Ongoing treatments for psychiatric and medical conditions present must have been stable for the 3 months prior to study entry, and must be expected to remain stable during participation in the study * Patients must be willing to abstain from taking medications (other than study drug) to help them sleep during participation in the study * Patients must be willing to consistently spend at least 7 hours each night either sleeping or trying to sleep during participation in the study * Patients must be able to speak and read English and be capable of using a computer with a web browser (computers with internet connections will be provided to patients who need them)
Exclusion criteria
* Unusual or unstable sleep/wake schedule, such as with rotating shift work * Severe or unstable psychiatric or medical illness * Suicidal ideation * Substance abuse * Known obstructive sleep apnea, restless leg syndrome, or periodic limb movement disorder * History of seizures * Body Mass Index \> 33 * Clinically significant abnormality in clinical chemistry, hematology, urinalysis, and/or electrocardiogram * Anticipated inability to regularly use a medication which might reduce motor or cognitive functioning during sleeping hours, such as a person who might often need to be on call, drive a car, or be responsible for the care of another person during sleeping hours * Contraindication to zolpidem * History of breast cancer * An estimated glomerular filtration rate (GFR; an index of renal function) that is \<30 mL/min at study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary) |
| Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary). |
| Treatment Satisfaction as Measured by the Participant Drug Preference Question | Baseline (Period A) and 2 weeks (Period B) | After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B. |
| Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 weeks | Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category. |
| Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 weeks | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category. |
| Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Baseline, 2 weeks | Unwanted time awake (minutes awake \[MA\] before sleep \[between turning off the lights to first falling asleep\], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type | Baseline through 8 weeks | Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants. |
| Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group | Baseline, 2 weeks | Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group | Baseline through 8 weeks | Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants. |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | Baseline through 8 weeks | Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module. |
| Number of Participants With Serious Adverse Events (SAEs) | Baseline through 8 weeks | SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module. |
| Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Baseline, 2 weeks of treatment over 8 weeks | Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment. |
| Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Baseline, 2 weeks of treatment over 8 weeks | Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment. |
| Change From Baseline in Weight at Each 2-week Treatment Endpoint | Baseline, 2 weeks of treatment over 8 weeks | Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment. |
| Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | 2 weeks of treatment over 8 weeks | Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range). |
| Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Baseline, 2 weeks of treatment over 8 weeks | Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment. |
| Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Baseline, 2 weeks of treatment over 8 weeks | QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment. |
| Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type | Baseline, 2 weeks | Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants. |
Countries
United States
Participant flow
Recruitment details
LY2624803 was placed on clinical hold by Food and Drug Administration (FDA) on 18 December 2008. The FDA lifted the clinical hold effective 05 May 2009. For analysis purposes, participants who entered into study during 2008 were designated as Cohort 1, whereas participants who entered into study after 2008 were designated as Cohort 2.
Pre-assignment details
None of Cohort 1 participants completed the study and few progressed beyond Period B. The efficacy analyses were conducted using data from Cohort 2 participants only. Participant flow includes participants from both cohorts.
Participants by arm
| Arm | Count |
|---|---|
| LY2624803 1 mg Participants received LY2624803 1 mg in Period B (2-week treatment period). | 102 |
| LY2624803 3 mg Participants received LY2624803 3 mg in Period B (2-week treatment period). | 102 |
| Zolpidem 5 or 10 mg Participants received Zolpidem 5 or 10 mg in Period B (2-week treatment period). | 102 |
| Placebo Participants received placebo in Period B (2-week treatment period). | 101 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period A - Baseline | Adverse Event | 0 | 0 | 0 | 8 |
| Period A - Baseline | Entry Criteria Not Met | 0 | 0 | 0 | 5 |
| Period A - Baseline | Lost to Follow-up | 0 | 0 | 0 | 2 |
| Period A - Baseline | Physician Decision | 0 | 0 | 0 | 2 |
| Period A - Baseline | Protocol Violation | 0 | 0 | 0 | 25 |
| Period A - Baseline | Sponsor Decision | 0 | 0 | 0 | 113 |
| Period A - Baseline | Withdrawal by Subject | 0 | 0 | 0 | 27 |
| Period B - Efficacy Endpoint | Adverse Event | 0 | 3 | 2 | 1 |
| Period B - Efficacy Endpoint | Entry Criteria Not Met | 0 | 0 | 2 | 1 |
| Period B - Efficacy Endpoint | Lack of Efficacy | 0 | 1 | 0 | 0 |
| Period B - Efficacy Endpoint | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Period B - Efficacy Endpoint | Physician Decision | 0 | 0 | 1 | 0 |
| Period B - Efficacy Endpoint | Protocol Violation | 1 | 1 | 2 | 3 |
| Period B - Efficacy Endpoint | Sponsor Decision | 9 | 6 | 12 | 12 |
| Period B - Efficacy Endpoint | Withdrawal by Subject | 4 | 1 | 1 | 2 |
| Period C | Adverse Event | 1 | 0 | 4 | 2 |
| Period C | Lack of Efficacy | 0 | 0 | 1 | 0 |
| Period C | Physician Decision | 0 | 0 | 1 | 1 |
| Period C | Protocol Violation | 0 | 0 | 1 | 2 |
| Period C | Sponsor Decision | 5 | 5 | 4 | 2 |
| Period C | Withdrawal by Subject | 1 | 1 | 2 | 0 |
| Period D | Adverse Event | 0 | 2 | 2 | 0 |
| Period D | Lost to Follow-up | 1 | 0 | 1 | 1 |
| Period D | Physician Decision | 0 | 1 | 0 | 0 |
| Period D | Protocol Violation | 1 | 0 | 0 | 0 |
| Period D | Sponsor Decision | 1 | 1 | 1 | 0 |
| Period D | Withdrawal by Subject | 2 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Zolpidem 5 or 10 mg | LY2624803 1 mg | Total | Placebo | LY2624803 3 mg |
|---|---|---|---|---|---|
| Age Continuous | 50.65 years STANDARD_DEVIATION 15 | 52.81 years STANDARD_DEVIATION 14.07 | 52.27 years STANDARD_DEVIATION 14.35 | 52.86 years STANDARD_DEVIATION 13.66 | 52.77 years STANDARD_DEVIATION 14.73 |
| Race/Ethnicity, Customized African | 12 participants | 21 participants | 72 participants | 18 participants | 21 participants |
| Race/Ethnicity, Customized Caucasian | 85 participants | 75 participants | 306 participants | 72 participants | 74 participants |
| Race/Ethnicity, Customized East Asian | 1 participants | 0 participants | 5 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 3 participants | 6 participants | 23 participants | 9 participants | 5 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 102 participants | 102 participants | 407 participants | 101 participants | 102 participants |
| Sex: Female, Male Female | 61 Participants | 66 Participants | 240 Participants | 61 Participants | 52 Participants |
| Sex: Female, Male Male | 41 Participants | 36 Participants | 167 Participants | 40 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 114 | 18 / 113 | 21 / 117 | 33 / 117 | 26 / 103 | 34 / 97 | 22 / 98 | 42 / 97 | 29 / 91 | 35 / 89 | 25 / 88 | 34 / 94 |
| serious Total, serious adverse events | 1 / 114 | 1 / 113 | 0 / 117 | 1 / 117 | 0 / 103 | 0 / 97 | 2 / 98 | 1 / 97 | 0 / 91 | 0 / 89 | 0 / 88 | 0 / 94 |
Outcome results
Primary
Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). Analysis of covariance (ANCOVA) Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | 30.16 minutes | Standard Error 5.3 |
| LY2624803 3 mg | Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | 37.33 minutes | Standard Error 5.186 |
| Zolpidem 5 or 10 mg | Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | 50.63 minutes | Standard Error 5.186 |
| Placebo | Change From Baseline in Average Nightly Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint | 22.79 minutes | Standard Error 5.153 |
Secondary
Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint
Assessment of Sleep Quality (ASQ) scale is asked in the participant-reported daily sleep questionnaire; 8 items on 4 point Likert scale with a range of 0 to 24. Sleep experience score ranges from 0-9; awakening experience ranges from 0-15. The higher the score, the better the sleep. Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Sleep Experience Subscale | 0.22 units on a scale | Standard Error 0.042 |
| LY2624803 1 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Total Score | 0.17 units on a scale | Standard Error 0.035 |
| LY2624803 1 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Feeling upon Awakening Subscale | 0.14 units on a scale | Standard Error 0.034 |
| LY2624803 3 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Total Score | 0.17 units on a scale | Standard Error 0.034 |
| LY2624803 3 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Sleep Experience Subscale | 0.24 units on a scale | Standard Error 0.042 |
| LY2624803 3 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Feeling upon Awakening Subscale | 0.13 units on a scale | Standard Error 0.033 |
| Zolpidem 5 or 10 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Feeling upon Awakening Subscale | 0.19 units on a scale | Standard Error 0.033 |
| Zolpidem 5 or 10 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Total Score | 0.25 units on a scale | Standard Error 0.034 |
| Zolpidem 5 or 10 mg | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Sleep Experience Subscale | 0.35 units on a scale | Standard Error 0.042 |
| Placebo | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Total Score | 0.13 units on a scale | Standard Error 0.034 |
| Placebo | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Sleep Experience Subscale | 0.15 units on a scale | Standard Error 0.041 |
| Placebo | Change From Baseline in Assessment of Sleep Quality at Week 4 (Week 2 of Period B) Endpoint | Feeling upon Awakening Subscale | 0.12 units on a scale | Standard Error 0.033 |
Secondary
Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for systolic blood pressure (SBP) and diastolic blood pressure (DBP) are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Population: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: SBP (n= 112, 111, 117, 117) | 0.83 mmHg | Standard Error 0.908 |
| LY2624803 1 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: SBP (n= 91, 89, 93, 88) | 0.03 mmHg | Standard Error 1.097 |
| LY2624803 1 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: DBP (n= 102, 97, 97, 97) | 0.35 mmHg | Standard Error 0.675 |
| LY2624803 1 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: DBP (n= 112, 111, 117, 117) | 0.15 mmHg | Standard Error 0.607 |
| LY2624803 1 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: DBP (n= 91, 89, 93, 88) | 0.33 mmHg | Standard Error 0.751 |
| LY2624803 1 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: SBP (n= 102, 97, 97, 97) | 2.31 mmHg | Standard Error 0.932 |
| LY2624803 3 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: DBP (n= 112, 111, 117, 117) | 0.21 mmHg | Standard Error 0.61 |
| LY2624803 3 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: DBP (n= 102, 97, 97, 97) | 1.11 mmHg | Standard Error 0.693 |
| LY2624803 3 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: SBP (n= 112, 111, 117, 117) | 0.91 mmHg | Standard Error 0.912 |
| LY2624803 3 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: SBP (n= 102, 97, 97, 97) | 1.54 mmHg | Standard Error 0.96 |
| LY2624803 3 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: DBP (n= 91, 89, 93, 88) | -0.31 mmHg | Standard Error 0.76 |
| LY2624803 3 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: SBP (n= 91, 89, 93, 88) | 1.17 mmHg | Standard Error 1.109 |
| Zolpidem 5 or 10 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: DBP (n= 91, 89, 93, 88) | 0.37 mmHg | Standard Error 0.743 |
| Zolpidem 5 or 10 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: SBP (n= 102, 97, 97, 97) | 0.68 mmHg | Standard Error 0.957 |
| Zolpidem 5 or 10 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: DBP (n= 102, 97, 97, 97) | -0.68 mmHg | Standard Error 0.693 |
| Zolpidem 5 or 10 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: DBP (n= 112, 111, 117, 117) | -0.45 mmHg | Standard Error 0.594 |
| Zolpidem 5 or 10 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: SBP (n= 112, 111, 117, 117) | -0.05 mmHg | Standard Error 0.888 |
| Zolpidem 5 or 10 mg | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: SBP (n= 91, 89, 93, 88) | 0.87 mmHg | Standard Error 1.085 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: DBP (n= 102, 97, 97, 97) | -0.51 mmHg | Standard Error 0.693 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: SBP (n= 91, 89, 93, 88) | 2.39 mmHg | Standard Error 1.118 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period C: SBP (n= 102, 97, 97, 97) | 0.58 mmHg | Standard Error 0.958 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period D: DBP (n= 91, 89, 93, 88) | 0.75 mmHg | Standard Error 0.764 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: SBP (n= 112, 111, 117, 117) | -0.37 mmHg | Standard Error 0.888 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Each 2-Week Treatment Endpoint | Period B: DBP (n= 112, 111, 117, 117) | -0.41 mmHg | Standard Error 0.594 |
Secondary
Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint
The EuroQoL Questionnaire-5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. The score ranges 0-100. The higher score indicates a better health state perceived by the participant. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint | -3.06 units on a scale | Standard Error 1.525 |
| LY2624803 3 mg | Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint | -2.56 units on a scale | Standard Error 1.503 |
| Zolpidem 5 or 10 mg | Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint | -1.71 units on a scale | Standard Error 1.51 |
| Placebo | Change From Baseline in Health-related Quality of Life as Measured by European Quality of Life (EuroQol) at Week 4 (Week 2 of Period B) Endpoint | 0.23 units on a scale | Standard Error 1.503 |
Secondary
Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for heart rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Population: All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | 1.09 beats per minute | Standard Error 0.689 |
| LY2624803 1 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | -0.59 beats per minute | Standard Error 0.734 |
| LY2624803 1 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91,86, 93, 87) | 1.71 beats per minute | Standard Error 0.827 |
| LY2624803 3 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | 0.31 beats per minute | Standard Error 0.753 |
| LY2624803 3 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91,86, 93, 87) | 1.71 beats per minute | Standard Error 0.851 |
| LY2624803 3 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | 0.26 beats per minute | Standard Error 0.695 |
| Zolpidem 5 or 10 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | 1.10 beats per minute | Standard Error 0.681 |
| Zolpidem 5 or 10 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91,86, 93, 87) | 1.43 beats per minute | Standard Error 0.818 |
| Zolpidem 5 or 10 mg | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | -0.02 beats per minute | Standard Error 0.745 |
| Placebo | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91,86, 93, 87) | 0.86 beats per minute | Standard Error 0.846 |
| Placebo | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | 0.30 beats per minute | Standard Error 0.688 |
| Placebo | Change From Baseline in Heart Rate as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | 1.14 beats per minute | Standard Error 0.749 |
Secondary
Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint
Elicited from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint | -0.27 number of awakenings | Standard Error 0.066 |
| LY2624803 3 mg | Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint | -0.26 number of awakenings | Standard Error 0.065 |
| Zolpidem 5 or 10 mg | Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint | -0.59 number of awakenings | Standard Error 0.065 |
| Placebo | Change From Baseline in Number of Awakenings During Sleep at Week 4 (Week 2 of Period B) Endpoint | -0.18 number of awakenings | Standard Error 0.065 |
Secondary
Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint
DCIQ scale is asked in the participant-reported daily evening questionnaire; 5 point Likert scale with minimum of 0 and maximum of 44 (the higher the score, the more consequences of insomnia). Scale is averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint | -1.23 units on a scale | Standard Error 0.395 |
| LY2624803 3 mg | Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint | -0.87 units on a scale | Standard Error 0.385 |
| Zolpidem 5 or 10 mg | Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint | -1.20 units on a scale | Standard Error 0.394 |
| Placebo | Change From Baseline in Participants' Impression of Daytime Functioning Measured by Daily Consequences of Insomnia Questionnaire (DCIQ) at Week 4 (Week 2 of Period B) Endpoint | -0.73 units on a scale | Standard Error 0.386 |
Secondary
Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint
The SF-12 is a subset of 12 items from the Medical Outcomes Study 36-Item Short Form Survey (SF-36) and was collected at the bi-weekly office visits. Each score ranges from 0-100. The components measure physical and mental health, respectively. Higher scores are indicative of better function. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary)
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Mental Component Scores | 2.49 units on a scale | Standard Error 1.198 |
| LY2624803 1 mg | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Physical Component Scores | -2.32 units on a scale | Standard Error 1.001 |
| LY2624803 3 mg | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Mental Component Scores | 1.11 units on a scale | Standard Error 1.181 |
| LY2624803 3 mg | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Physical Component Scores | -0.28 units on a scale | Standard Error 0.987 |
| Zolpidem 5 or 10 mg | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Physical Component Scores | -0.82 units on a scale | Standard Error 0.992 |
| Zolpidem 5 or 10 mg | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Mental Component Scores | 1.21 units on a scale | Standard Error 1.191 |
| Placebo | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Mental Component Scores | 1.94 units on a scale | Standard Error 1.184 |
| Placebo | Change From Baseline in Physical and Mental Component Scores as Measured by the Short Form 12 (SF-12) Version 2 at Week 4 (Week 2 of Period B) Endpoint | Physical Component Scores | -1.84 units on a scale | Standard Error 0.991 |
Secondary
Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for pulse rate are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Population: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period B (n= 112, 111, 117, 117) | 0.65 beats per minute | Standard Error 0.664 |
| LY2624803 1 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period D (n= 91, 89, 93, 88) | 0.48 beats per minute | Standard Error 0.813 |
| LY2624803 1 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period C (n= 102, 97, 97, 97) | 0.42 beats per minute | Standard Error 0.758 |
| LY2624803 3 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period B (n= 112, 111, 117, 117) | 0.95 beats per minute | Standard Error 0.669 |
| LY2624803 3 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period D (n= 91, 89, 93, 88) | -0.36 beats per minute | Standard Error 0.82 |
| LY2624803 3 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period C (n= 102, 97, 97, 97) | 0.94 beats per minute | Standard Error 0.777 |
| Zolpidem 5 or 10 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period C (n= 102, 97, 97, 97) | -0.64 beats per minute | Standard Error 0.777 |
| Zolpidem 5 or 10 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period B (n= 112, 111, 117, 117) | 0.41 beats per minute | Standard Error 0.653 |
| Zolpidem 5 or 10 mg | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period D (n= 91, 89, 93, 88) | 1.49 beats per minute | Standard Error 0.803 |
| Placebo | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period B (n= 112, 111, 117, 117) | 0.62 beats per minute | Standard Error 0.649 |
| Placebo | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period D (n= 91, 89, 93, 88) | 1.40 beats per minute | Standard Error 0.826 |
| Placebo | Change From Baseline in Pulse Rate at Each 2-week Treatment Endpoint | Period C (n= 102, 97, 97, 97) | -0.02 beats per minute | Standard Error 0.777 |
Secondary
Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF is the QT interval corrected for heart rate using Fridericia formula. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Population: All randomized Cohort 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91, 86, 93, 87) | -2.00 milliseconds | Standard Error 1.319 |
| LY2624803 1 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | -0.04 milliseconds | Standard Error 1.314 |
| LY2624803 1 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | -1.07 milliseconds | Standard Error 1.335 |
| LY2624803 3 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | -0.41 milliseconds | Standard Error 1.373 |
| LY2624803 3 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | -2.62 milliseconds | Standard Error 1.325 |
| LY2624803 3 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91, 86, 93, 87) | -2.99 milliseconds | Standard Error 1.344 |
| Zolpidem 5 or 10 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | -3.27 milliseconds | Standard Error 1.356 |
| Zolpidem 5 or 10 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | -1.02 milliseconds | Standard Error 1.3 |
| Zolpidem 5 or 10 mg | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91, 86, 93, 87) | -3.59 milliseconds | Standard Error 1.293 |
| Placebo | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period B (n= 112, 110, 115, 112) | -1.43 milliseconds | Standard Error 1.316 |
| Placebo | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period D (n= 91, 86, 93, 87) | -1.68 milliseconds | Standard Error 1.339 |
| Placebo | Change From Baseline in QT Interval Corrected Using Fridericia Formula (QTcF) as Measured by Electrocardiogram (ECG) at Each 2-week Treatment Endpoint | Period C (n= 99, 94, 96, 95) | -3.92 milliseconds | Standard Error 1.37 |
Secondary
Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint
Calculated as (TIB-TTA)/TIB where TIB is time in bed and TTA is total unwanted time awake. Higher score indicates better sleep efficiency. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint | 0.06 ratio | Standard Error 0.009 |
| LY2624803 3 mg | Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint | 0.06 ratio | Standard Error 0.009 |
| Zolpidem 5 or 10 mg | Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint | 0.10 ratio | Standard Error 0.009 |
| Placebo | Change From Baseline in Sleep Efficiency at Week 4 (Week 2 of Period B) Endpoint | 0.03 ratio | Standard Error 0.009 |
Secondary
Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint
The ISI is a brief self-report instrument that measures a participant's perception of his or her insomnia. 7 questions on 5-point Likert scale with minimum of 0 and maximum of 28. The higher the score, the more severe the insomnia. It was collected at the bi-weekly office visits. ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint | -2.85 units on a scale | Standard Error 0.587 |
| LY2624803 3 mg | Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint | -2.83 units on a scale | Standard Error 0.578 |
| Zolpidem 5 or 10 mg | Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint | -4.63 units on a scale | Standard Error 0.582 |
| Placebo | Change From Baseline in the Insomnia Severity Index (ISI) at Week 4 (Week 2 of Period B) Endpoint | -1.95 units on a scale | Standard Error 0.574 |
Secondary
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Age Group
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Time frame: Baseline, 2 weeks
Population: Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.
Secondary
Change From Baseline in Total Sleep Time at Week 4 (Week 2 of Period B) Endpoint Based on Insomnia Type
Total Sleep Time is defined as time in bed minus total time awake. Minimum would be 0; no defined maximum (except if as defined as time in bed). The higher the number, the more time asleep. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Time frame: Baseline, 2 weeks
Population: Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.
Secondary
Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint
Calculated in minutes from participant-reported daily sleep questionnaire averaged across study Period B (2 weeks). Change score subtracts Period B average from Period A average (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group (\<65 or ≥65), and insomnia type (primary vs. secondary).
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint | -28.63 minutes | Standard Error 4.678 |
| LY2624803 3 mg | Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint | -28.62 minutes | Standard Error 4.591 |
| Zolpidem 5 or 10 mg | Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint | -47.28 minutes | Standard Error 4.579 |
| Placebo | Change From Baseline in Total Time Awake at Week 4 (Week 2 of Period B) Endpoint | -13.09 minutes | Standard Error 4.547 |
Secondary
Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint
Unwanted time awake (minutes awake \[MA\] before sleep \[between turning off the lights to first falling asleep\], MA during sleep, MA after sleep before getting out of bed). Minimum would be 0; no defined maximum. The higher the number, the more the unwanted time awake. Calculated in minutes from participant-reported daily sleep questionnaire averaged (Avg.) across Period B. Change score subtracts Period B Avg. from Period A Avg. (baseline). ANCOVA Model with dependent variable being change from baseline scores and independent variables being treatment, baseline, age group, and insomnia type.
Time frame: Baseline, 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | After Sleep (n= 100, 101, 99, 99) | -9.07 minutes | Standard Error 2.15 |
| LY2624803 1 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | During Sleep (n= 101, 102, 101, 101) | -14.84 minutes | Standard Error 2.881 |
| LY2624803 1 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Before Sleep (n= 101, 101, 101, 101) | -7.08 minutes | Standard Error 2.524 |
| LY2624803 3 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | After Sleep (n= 100, 101, 99, 99) | -8.31 minutes | Standard Error 2.108 |
| LY2624803 3 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Before Sleep (n= 101, 101, 101, 101) | -6.45 minutes | Standard Error 2.444 |
| LY2624803 3 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | During Sleep (n= 101, 102, 101, 101) | -12.95 minutes | Standard Error 2.812 |
| Zolpidem 5 or 10 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | During Sleep (n= 101, 102, 101, 101) | -21.46 minutes | Standard Error 2.819 |
| Zolpidem 5 or 10 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Before Sleep (n= 101, 101, 101, 101) | -20.48 minutes | Standard Error 2.44 |
| Zolpidem 5 or 10 mg | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | After Sleep (n= 100, 101, 99, 99) | -4.91 minutes | Standard Error 2.119 |
| Placebo | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | After Sleep (n= 100, 101, 99, 99) | -5.05 minutes | Standard Error 2.105 |
| Placebo | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | During Sleep (n= 101, 102, 101, 101) | -8.23 minutes | Standard Error 2.794 |
| Placebo | Change From Baseline in Unwanted Time Awake at Week 4 (Week 2 of Period B) Endpoint | Before Sleep (n= 101, 101, 101, 101) | -1.46 minutes | Standard Error 2.42 |
Secondary
Change From Baseline in Weight at Each 2-week Treatment Endpoint
Change from baseline to the end of each of the 2-week treatment periods (Periods B, C, and D) for body weight are presented. Least Squares Mean (LSMean) values were adjusted for baseline and treatment.
Time frame: Baseline, 2 weeks of treatment over 8 weeks
Population: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| LY2624803 1 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period D (n=91, 90, 93, 88) | 0.12 kilogram | Standard Error 0.164 |
| LY2624803 1 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period B (n= 111, 111, 115, 114) | 0.13 kilogram | Standard Error 0.105 |
| LY2624803 1 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period C (n= 104, 100, 97, 96) | 0.03 kilogram | Standard Error 0.129 |
| LY2624803 3 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period B (n= 111, 111, 115, 114) | 0.27 kilogram | Standard Error 0.105 |
| LY2624803 3 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period D (n=91, 90, 93, 88) | 0.17 kilogram | Standard Error 0.165 |
| LY2624803 3 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period C (n= 104, 100, 97, 96) | 0.30 kilogram | Standard Error 0.132 |
| Zolpidem 5 or 10 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period C (n= 104, 100, 97, 96) | -0.07 kilogram | Standard Error 0.135 |
| Zolpidem 5 or 10 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period B (n= 111, 111, 115, 114) | -0.08 kilogram | Standard Error 0.103 |
| Zolpidem 5 or 10 mg | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period D (n=91, 90, 93, 88) | 0.08 kilogram | Standard Error 0.162 |
| Placebo | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period B (n= 111, 111, 115, 114) | 0.06 kilogram | Standard Error 0.104 |
| Placebo | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period D (n=91, 90, 93, 88) | 0.03 kilogram | Standard Error 0.166 |
| Placebo | Change From Baseline in Weight at Each 2-week Treatment Endpoint | Period C (n= 104, 100, 97, 96) | 0.09 kilogram | Standard Error 0.134 |
Secondary
Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
Time frame: 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LY2624803 1 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 8.8 percentage of participants |
| LY2624803 1 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 2.0 percentage of participants |
| LY2624803 1 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally Worse | 2.0 percentage of participants |
| LY2624803 1 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 20.6 percentage of participants |
| LY2624803 1 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 0 percentage of participants |
| LY2624803 1 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 45.1 percentage of participants |
| LY2624803 1 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 21.6 percentage of participants |
| LY2624803 3 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 1.0 percentage of participants |
| LY2624803 3 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 28.4 percentage of participants |
| LY2624803 3 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 37.3 percentage of participants |
| LY2624803 3 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally Worse | 0 percentage of participants |
| LY2624803 3 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 0 percentage of participants |
| LY2624803 3 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 23.5 percentage of participants |
| LY2624803 3 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 9.8 percentage of participants |
| Zolpidem 5 or 10 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 16.7 percentage of participants |
| Zolpidem 5 or 10 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 15.7 percentage of participants |
| Zolpidem 5 or 10 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 34.3 percentage of participants |
| Zolpidem 5 or 10 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 30.4 percentage of participants |
| Zolpidem 5 or 10 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally Worse | 1.0 percentage of participants |
| Zolpidem 5 or 10 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 2.0 percentage of participants |
| Zolpidem 5 or 10 mg | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 0 percentage of participants |
| Placebo | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 33.3 percentage of participants |
| Placebo | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 0 percentage of participants |
| Placebo | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 0 percentage of participants |
| Placebo | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 18.2 percentage of participants |
| Placebo | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 5.1 percentage of participants |
| Placebo | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally Worse | 3.0 percentage of participants |
| Placebo | Clinical Global Impression of Improvement (CGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 40.4 percentage of participants |
Secondary
Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint
Summary of number of participants with abnormal clinical chemistry, hematology and urinalysis laboratory results. A participant is included in the abnormal category if he/she experienced a result outside the normal reference ranges based on Lilly's reference range in the current period. All analytes have both lower and upper limits. The abnormal number includes both low (below normal range) and high (above normal range).
Time frame: 2 weeks of treatment over 8 weeks
Population: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug, and had endpoint value. For LY2624803 1 mg, LY2624803 3 mg, Zolpidem 5 or 10 mg, and Placebo, the Number of Participants Analyzed were as follows: Period B: N=114, 113,117, 117; Period C: N=103, 97, 97, 98; and Period D: N=91, 89, 94, 88.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Blood Urea Nitrogen | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Total Bilirubin | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Aspartate Transaminase | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Glucose, Non-fasting or random | 6 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alkaline Phosphatase | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alanine Transaminase | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alkaline Phosphatase | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Blood Urea Nitrogen | 2 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Platelet Count | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Leukocyte Count | 2 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Hemoglobin | 2 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Glucose, Non-fasting or random | 6 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatinine | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Aspartate Transaminase | 2 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Platelet Count | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatine Phosphokinase | 2 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alkaline Phosphatase | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Leukocyte Count | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Total Bilirubin | 3 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Aspartate Transaminase | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alanine Transaminase | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Total Bilirubin | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alanine Transaminase | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Platelet Count | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Leukocyte Count | 2 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Hemoglobin | 0 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Hemoglobin | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Glucose, Non-fasting or random | 4 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatine Phosphokinase | 1 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Blood Urea Nitrogen | 2 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatinine | 3 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatine Phosphokinase | 3 participants |
| LY2624803 1 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatinine | 3 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Aspartate Transaminase | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Aspartate Transaminase | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Blood Urea Nitrogen | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatine Phosphokinase | 2 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Platelet Count | 3 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alkaline Phosphatase | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alanine Transaminase | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Total Bilirubin | 2 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatine Phosphokinase | 3 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatinine | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Glucose, Non-fasting or random | 4 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Hemoglobin | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Leukocyte Count | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Platelet Count | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alkaline Phosphatase | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alanine Transaminase | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Aspartate Transaminase | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Total Bilirubin | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatinine | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Glucose, Non-fasting or random | 5 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Blood Urea Nitrogen | 2 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Hemoglobin | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Leukocyte Count | 3 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Platelet Count | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alkaline Phosphatase | 0 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alanine Transaminase | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Total Bilirubin | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatine Phosphokinase | 2 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatinine | 4 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Glucose, Non-fasting or random | 2 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Blood Urea Nitrogen | 2 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Hemoglobin | 1 participants |
| LY2624803 3 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Leukocyte Count | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Total Bilirubin | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Aspartate Transaminase | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Blood Urea Nitrogen | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alkaline Phosphatase | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Hemoglobin | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Total Bilirubin | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatine Phosphokinase | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Platelet Count | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatinine | 4 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatine Phosphokinase | 5 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Aspartate Transaminase | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Glucose, Non-fasting or random | 4 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Hemoglobin | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Leukocyte Count | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatine Phosphokinase | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Glucose, Non-fasting or random | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Leukocyte Count | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Total Bilirubin | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Blood Urea Nitrogen | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatinine | 4 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Platelet Count | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Platelet Count | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Blood Urea Nitrogen | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alkaline Phosphatase | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alkaline Phosphatase | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatinine | 4 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Glucose, Non-fasting or random | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alanine Transaminase | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alanine Transaminase | 2 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alanine Transaminase | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Leukocyte Count | 3 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Aspartate Transaminase | 0 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Hemoglobin | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alanine Transaminase | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Total Bilirubin | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatine Phosphokinase | 4 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatine Phosphokinase | 2 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Glucose, Non-fasting or random | 2 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Creatinine | 3 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Total Bilirubin | 2 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Platelet Count | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Leukocyte Count | 5 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Blood Urea Nitrogen | 3 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Hemoglobin | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Blood Urea Nitrogen | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Leukocyte Count | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alanine Transaminase | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Glucose, Non-fasting or random | 5 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Aspartate Transaminase | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alkaline Phosphatase | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Alkaline Phosphatase | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Aspartate Transaminase | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Hemoglobin | 2 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Total Bilirubin | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatine Phosphokinase | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Alanine Transaminase | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Hemoglobin | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Blood Urea Nitrogen | 2 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Platelet Count | 1 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Leukocyte Count | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Platelet Count | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Glucose, Non-fasting or random | 3 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period D: Creatinine | 2 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Alkaline Phosphatase | 0 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period B: Creatinine | 5 participants |
| Placebo | Number of Participants With Abnormal Laboratory Analytes at Each 2-Week Treatment Endpoint | Period C: Aspartate Transaminase | 0 participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Age Group
Number of participants with AEs and SAEs. Analyses were not performed by age group (under age 65 versus over age 65) as originally planned because of insufficient number of elderly participants.
Time frame: Baseline through 8 weeks
Population: Analyses were not performed by age group because of insufficient number of elderly patients. Zero participants were analyzed.
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Insomnia Type
Number of participants with AEs and SAEs. Analyses were not performed by insomnia type (primary versus secondary) as originally planned because of insufficient number of secondary insomnia participants.
Time frame: Baseline through 8 weeks
Population: Analyses were not performed by insomnia type because of insufficient number of secondary insomnia patients. Zero participants were analyzed.
Secondary
Number of Participants With Serious Adverse Events (SAEs)
SAEs do not distinguish whether the events are treatment-emergent. A summary of SAEs is located in the Reported Adverse Event module.
Time frame: Baseline through 8 weeks
Population: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LY2624803 1 mg | Number of Participants With Serious Adverse Events (SAEs) | 1 participants |
| LY2624803 3 mg | Number of Participants With Serious Adverse Events (SAEs) | 1 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Serious Adverse Events (SAEs) | 2 participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) | 2 participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Treatment Emergent Adverse Events (TEAEs) are defined as AEs that first occurred or worsened during the treatment period. TEAEs are summarized by study period and treatment group. TEAEs do not distinguish whether the events were deemed serious. A summary of non-serious AEs is located in the Reported Adverse Event module.
Time frame: Baseline through 8 weeks
Population: All randomized Cohorts 1 and 2 participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LY2624803 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period B (n= 114, 113, 117, 117) | 28 participants |
| LY2624803 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period D (n= 91, 89, 94, 88) | 29 participants |
| LY2624803 1 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period C (n= 103, 97, 97, 98) | 26 participants |
| LY2624803 3 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period B (n= 114, 113, 117, 117) | 18 participants |
| LY2624803 3 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period D (n= 91, 89, 94, 88) | 35 participants |
| LY2624803 3 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period C (n= 103, 97, 97, 98) | 34 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period C (n= 103, 97, 97, 98) | 42 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period B (n= 114, 113, 117, 117) | 33 participants |
| Zolpidem 5 or 10 mg | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period D (n= 91, 89, 94, 88) | 34 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period B (n= 114, 113, 117, 117) | 21 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period D (n= 91, 89, 94, 88) | 25 participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAE) | Period C (n= 103, 97, 97, 98) | 22 participants |
Secondary
Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much improved) to 7 (very much worse). Data are presented as percentage of participants in each category.
Time frame: 2 weeks
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LY2624803 1 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally worse | 1.0 percentage of participants |
| LY2624803 1 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 1.0 percentage of participants |
| LY2624803 1 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 62.6 percentage of participants |
| LY2624803 1 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 11.1 percentage of participants |
| LY2624803 1 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 0 percentage of participants |
| LY2624803 1 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 0 percentage of participants |
| LY2624803 1 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 24.2 percentage of participants |
| LY2624803 3 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 2.1 percentage of participants |
| LY2624803 3 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally worse | 2.1 percentage of participants |
| LY2624803 3 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 1.0 percentage of participants |
| LY2624803 3 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 16.7 percentage of participants |
| LY2624803 3 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 31.3 percentage of participants |
| LY2624803 3 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 45.8 percentage of participants |
| LY2624803 3 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 1.0 percentage of participants |
| Zolpidem 5 or 10 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 15.8 percentage of participants |
| Zolpidem 5 or 10 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 4.2 percentage of participants |
| Zolpidem 5 or 10 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 20.0 percentage of participants |
| Zolpidem 5 or 10 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 55.8 percentage of participants |
| Zolpidem 5 or 10 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally worse | 4.2 percentage of participants |
| Zolpidem 5 or 10 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 0 percentage of participants |
| Zolpidem 5 or 10 mg | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 0 percentage of participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 3 - Minimally improved | 42.6 percentage of participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 7 - Very much worse | 0 percentage of participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 6 - Much worse | 1.1 percentage of participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 2 - Much improved | 9.6 percentage of participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 1 - Very much improved | 3.2 percentage of participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 5 - Minimally worse | 6.4 percentage of participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) in Insomnia at Week 4 (Week 2 of Period B) Endpoint | 4 - No change | 37.2 percentage of participants |
Secondary
Treatment Satisfaction as Measured by the Participant Drug Preference Question
After study Periods A, and B, participants were asked to rate their experience with the treatment they had just completed. Data are presented as percentage of participants preferring the treatment received in Period A (placebo) or treatment received in Period B.
Time frame: Baseline (Period A) and 2 weeks (Period B)
Population: All randomized Cohort 2 participants who received at least one dose of study drug, and had both baseline and endpoint values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LY2624803 1 mg | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period B Treatment | 76.8 percentage of participants |
| LY2624803 1 mg | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period A Treatment (placebo) | 23.2 percentage of participants |
| LY2624803 3 mg | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period B Treatment | 77.1 percentage of participants |
| LY2624803 3 mg | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period A Treatment (placebo) | 22.9 percentage of participants |
| Zolpidem 5 or 10 mg | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period B Treatment | 87.4 percentage of participants |
| Zolpidem 5 or 10 mg | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period A Treatment (placebo) | 12.6 percentage of participants |
| Placebo | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period A Treatment (placebo) | 35.1 percentage of participants |
| Placebo | Treatment Satisfaction as Measured by the Participant Drug Preference Question | Period B Treatment | 64.9 percentage of participants |