Insomnia
Conditions
Keywords
insomnia, chronic, primary
Brief summary
To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.
Detailed description
A double-blind, randomized, placebo controlled, parallel group study of eszopiclone in elderly subjects with primary chronic insomnia. The study will involve up to 9 visits and subject participation will be approximately 18 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Interventions
DRUGEszopiclone
2 mg tablet once per day in the evening
DRUGPlacebo
Tablet one per day in the evening.
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.
Exclusion criteria
* Subject has recent history of known clinically significant abnormal laboratory findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. | Baseline (week 0), Day 1 (post first dose)-12 weeks | The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Weeks 0, 3, 6, 9, 12, 14, 16 | The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value. |
| Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Weeks 0, 3, 6, 9, 12, 14, 16 | The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period. | Baseline (week 0), Day 1 (post first dose) - Week12 | Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value. |
| Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Baseline (week 0), Weeks 3,6,9,12,14,16 | Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Weeks 0,3,6,9,12,14,16 | Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period. | Baseline (week 0), Day 1 (post first dose) -week 12 | Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value. |
| Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Baseline (week 0), weeks 3,6,9,12,14,16 | Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period. | Baseline (week 0), Day 1 (post first dose) - Week12 | The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Baseline (week 0), Weeks 3,6,9,12,14,16 | The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - Week12 | Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Baseline (week 0), Weeks 3,6,9,12,14,16 | Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | weeks 0,3,6,9,12,14,16 | Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period. | Baseline (week 0), Day 1 (post first dose) - week 12 | Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Baseline (week 0), Weeks 3,6,9,12,14,16 | Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-reported Depth of Sleep at Various Study Time Points | weeks 0,3,6,9,12,14,16 | Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Baseline (week 0), Weeks 3,6,9,12,14,16 | Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-reported Daytime Alertness at Various Study Time Points. | Weeks 0,3,6,9,12,14,16 | Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Baseline (week 0), Weeks 3,6,9,12,14,16 | Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-reported Ability to Function at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period. | Baseliine (week 0), Day 1 (post first dose) - week 12 | Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Baseline (week 0), Weeks 3,6,9,12,14,16 | Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-reported Ability to Concentrate at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Baseline (week 0), Weeks 3,6,9,12,14,16 | Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-reported Physical Well-Being at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose)- week 12 | Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Baseline (week 0), Weeks 3,6,9,12,14,16 | Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Weeks 0,3,6,9,12,14,16 | The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Baseline (week 0), Weeks 3,6,9,12,14,16 | Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-Reported Total Nap Time at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Baseline (week 0), Weeks 3,6,9,12,14,16 | Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value. |
| Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value. |
| Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Baseline (week 0), Weeks 1,4,7,12,13,15 | Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value. |
| Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Weeks 0,1,4,7,12,13,15 | Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values). |
| Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value. |
| Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Baseline (week 0), Weeks 1,4,7,12,13,15 | Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value. |
| Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Weeks 0,1,4,7,12,13,15 | Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader. |
| Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value. |
| Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Baseline (week 0), Weeks 1,4,7,12,13,15 | Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value. |
| Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | weeks 0,1,4,7,12,13,15 | Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values). |
| Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value. |
| Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Baseline (week 0), Weeks 1,4,7,12,13,15 | Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value. |
| Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Weeks 0,1,4,7,12,13,15 | Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values). |
| Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value. |
| Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Baseline (week 0), Weeks 1,4,7,12,13,15 | Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value. |
| Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 0,1,4,7,12,13,15 | The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values). |
| Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value. |
| Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Baseline (week 0), Weeks 1,4,7,12,13,15 | Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value. |
| Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 0,1,4,7,12,13,15 | The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values). |
| Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period. | Baseline (week 0), Day 1 (post first dose) - week 12 | Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value. |
| Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Baseline (week 0), Weeks 1,4,7,12,13,15 | Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value. |
| Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 0,1,4,7,12,13,15 | The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values). |
| Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period | Baseline (week 0), Day 1 (post first dose) - week 12 | Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value. |
| Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Baseline (week 0), Weeks 3,6,9,12,14,16 | Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value. |
| Mean Insomnia Severity Index Total Scores at Various Study Time Points | Weeks 0,3,6,9,12,14,16 | The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values). |
| Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale | Baseline (week 0), Weeks 6, 12, 16 | Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value. |
| Mean Physical Component Summary of the Short Form-36 Scale Scores. | Weeks 0,6,12,16 | This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16). |
| Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores | Baseline (week 0), Weeks 6,12,16 | Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value. |
| Mean Mental Component Summary of the Short Form-36 Scale Scores | Weeks 0,6,12,16 | This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16). |
| Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Baseline (week 0), Weeks 6,12,14,16 | Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value. |
| Mean Sheehan Disability Total Scores | Weeks 0,6,12,14,16 | Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16). |
Countries
United States
Participant flow
Pre-assignment details
823 participants were screened. Two participants in each arm completed all assessments for the double blind period but discontinued before starting the follow up period (withdrew consent; did not take any single blind medication in follow up period).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablets | 194 |
| Eszopiclone Eszopiclone 2 mg tablets | 194 |
| Total | 388 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double Blind Period | Adverse Event | 9 | 14 |
| Double Blind Period | Didnt Meet Entry/Randomization Criteria | 4 | 5 |
| Double Blind Period | Lack of Efficacy | 20 | 11 |
| Double Blind Period | Other | 3 | 3 |
| Double Blind Period | Protocol Violation | 1 | 1 |
| Double Blind Period | Withdrawal by Subject | 9 | 13 |
| Follow up:2 Week Placebo, 2 Week no Drug | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Eszopiclone | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 194 Participants | 194 Participants | 388 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 71.6 years STANDARD_DEVIATION 5 | 72.4 years STANDARD_DEVIATION 5.2 | 72.0 years STANDARD_DEVIATION 5.1 |
| Body Mass Index (BMI) | 28.25 Kilograms/Meters squared STANDARD_DEVIATION 4.9 | 27.28 Kilograms/Meters squared STANDARD_DEVIATION 4.98 | 27.76 Kilograms/Meters squared STANDARD_DEVIATION 4.96 |
| Height | 164.70 Centimeters STANDARD_DEVIATION 10.04 | 165.90 Centimeters STANDARD_DEVIATION 9.83 | 165.30 Centimeters STANDARD_DEVIATION 9.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 178 Participants | 181 Participants | 359 Participants |
| Region of Enrollment United States | 194 participants | 194 participants | 388 participants |
| Sex: Female, Male Female | 124 Participants | 119 Participants | 243 Participants |
| Sex: Female, Male Male | 70 Participants | 75 Participants | 145 Participants |
| Weight | 76.98 kilograms STANDARD_DEVIATION 16.72 | 75.44 kilograms STANDARD_DEVIATION 17.07 | 76.21 kilograms STANDARD_DEVIATION 16.89 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 61 / — | 86 / — |
| serious Total, serious adverse events | 2 / — | 4 / — |
Outcome results
Primary
Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period.
The difference between the total sleep time at baseline and the average total sleep time over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose)-12 weeks
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. | 33.18 minutes | Standard Deviation 50.02 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. | 63.24 minutes | Standard Deviation 52.76 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points
Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 6 (n=180,181) | -3.35 units on a scale | Standard Deviation 4.89 |
| Placebo | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 3 (n=179,181) | -2.74 units on a scale | Standard Deviation 4.51 |
| Placebo | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 14 (n=181,182) | -3.93 units on a scale | Standard Deviation 5.25 |
| Placebo | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 9 (n=180,182) | -3.55 units on a scale | Standard Deviation 5.1 |
| Placebo | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 16 (n=181,182) | -2.96 units on a scale | Standard Deviation 5.16 |
| Placebo | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 12 (n=180,182) | -4.05 units on a scale | Standard Deviation 5.15 |
| Eszopiclone | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 16 (n=181,182) | -2.96 units on a scale | Standard Deviation 5.24 |
| Eszopiclone | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 3 (n=179,181) | -4.94 units on a scale | Standard Deviation 5.38 |
| Eszopiclone | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 6 (n=180,181) | -5.67 units on a scale | Standard Deviation 5.88 |
| Eszopiclone | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 9 (n=180,182) | -5.89 units on a scale | Standard Deviation 5.88 |
| Eszopiclone | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 12 (n=180,182) | -6.18 units on a scale | Standard Deviation 5.96 |
| Eszopiclone | Mean Change From Baseline in Insomnia Severity Index Total Score at Various Study Time Points | Week 14 (n=181,182) | -4.06 units on a scale | Standard Deviation 5.88 |
Secondary
Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period
Change from baseline in the Insomnia Severity Index Total Score which ranges from 0-28. Lower scores represent better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period | -3.42 units on a scale | Standard Deviation 4.38 |
| Eszopiclone | Mean Change From Baseline in Insomnia Severity Index Total Score Averaged Over the 12 Week Double Blind Study Period | -5.67 units on a scale | Standard Deviation 5.26 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores
Mental component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50. Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
Time frame: Baseline (week 0), Weeks 6,12,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores | Week 6 (n=164,165) | -0.44 units on a scale | Standard Deviation 7.45 |
| Placebo | Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores | Week 12 (n=165,166) | -0.94 units on a scale | Standard Deviation 8 |
| Placebo | Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores | Week 16 (n=166,166) | -1.22 units on a scale | Standard Deviation 8.94 |
| Eszopiclone | Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores | Week 6 (n=164,165) | 0.96 units on a scale | Standard Deviation 8.59 |
| Eszopiclone | Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores | Week 12 (n=165,166) | 0.83 units on a scale | Standard Deviation 8.54 |
| Eszopiclone | Mean Change From Baseline in Mental Component Summary of the Short Form-36 Scale Scores | Week 16 (n=166,166) | 0.20 units on a scale | Standard Deviation 7.46 |
Secondary
Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | 0.87 number of awakenings | Standard Deviation 3.65 |
| Eszopiclone | Mean Change From Baseline in Number of Awakenings Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | -0.18 number of awakenings | Standard Deviation 4.28 |
p-value: 0.2643ANCOVA
Secondary
Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Change from baseline in the number of naps per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | 1.61 number of naps | Standard Deviation 9.06 |
| Eszopiclone | Mean Change From Baseline in Number of Naps Per Week Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | -2.67 number of naps | Standard Deviation 12.61 |
p-value: 0.0765ANCOVA
Secondary
Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale
Physical component summary of Short Form-36 Scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better than/worse than the general US population. Higher scores represent better outcomes. Change is calculated as time point value minus baseline value.
Time frame: Baseline (week 0), Weeks 6, 12, 16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale | Week 6 (n=164,165) | 1.01 units on a scale | Standard Deviation 7.73 |
| Placebo | Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale | Week 12 (n=165,166) | 1.38 units on a scale | Standard Deviation 7.6 |
| Placebo | Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale | Week 16 (n=166,166) | 0.69 units on a scale | Standard Deviation 7.99 |
| Eszopiclone | Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale | Week 6 (n=164,165) | 1.00 units on a scale | Standard Deviation 7.28 |
| Eszopiclone | Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale | Week 12 (n=165,166) | 1.01 units on a scale | Standard Deviation 7.14 |
| Eszopiclone | Mean Change From Baseline in Physical Component Summary of the Short Form-36 Scale | Week 16 (n=166,166) | 0.39 units on a scale | Standard Deviation 6.78 |
Secondary
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points
Sleep latency is a measurement of the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 1 (n=60,58) | 9.06 minutes | Standard Deviation 74.76 |
| Placebo | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 4 (n=61,61) | -2.16 minutes | Standard Deviation 44.61 |
| Placebo | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 7 (n=62,61) | 0.12 minutes | Standard Deviation 52.95 |
| Placebo | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 12 (n=62,61) | -3.92 minutes | Standard Deviation 36.22 |
| Placebo | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 13 (n=62,61) | -0.69 minutes | Standard Deviation 59.32 |
| Placebo | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 15 (n=62,61) | -3.66 minutes | Standard Deviation 39.21 |
| Eszopiclone | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 13 (n=62,61) | 16.13 minutes | Standard Deviation 66.04 |
| Eszopiclone | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 1 (n=60,58) | -0.25 minutes | Standard Deviation 18.92 |
| Eszopiclone | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 12 (n=62,61) | 9.34 minutes | Standard Deviation 57.32 |
| Eszopiclone | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 4 (n=61,61) | -1.48 minutes | Standard Deviation 27.74 |
| Eszopiclone | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 15 (n=62,61) | 6.44 minutes | Standard Deviation 36.59 |
| Eszopiclone | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy at Various Study Time Points | Week 7 (n=62,61) | -1.62 minutes | Standard Deviation 26.28 |
Secondary
Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period
Sleep latency is the time it takes to fall asleep. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | 0.00 minutes | Standard Deviation 40.75 |
| Eszopiclone | Mean Change From Baseline in Sleep Latency Measured Using Actigraphy Averaged Over the 12 Week Double Blind Study Period | 1.47 minutes | Standard Deviation 26.76 |
p-value: 0.78ANCOVA
Secondary
Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points.
Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 3 (n=189,191) | 0.32 units on a scale | Standard Deviation 0.89 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 6 (n=189,192) | 0.43 units on a scale | Standard Deviation 1.29 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 9 (n=189,192) | 0.60 units on a scale | Standard Deviation 1.53 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 12 (n=189,192) | 0.66 units on a scale | Standard Deviation 1.71 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 14 (n=189,192) | 0.72 units on a scale | Standard Deviation 1.81 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 16 (n=189,192) | 0.66 units on a scale | Standard Deviation 1.89 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 14 (n=189,192) | 1.00 units on a scale | Standard Deviation 1.87 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 3 (n=189,191) | 0.73 units on a scale | Standard Deviation 0.96 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 12 (n=189,192) | 1.14 units on a scale | Standard Deviation 1.57 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 6 (n=189,192) | 0.93 units on a scale | Standard Deviation 1.24 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 16 (n=189,192) | 0.93 units on a scale | Standard Deviation 1.93 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Concentrate at Various Study Time Points. | Week 9 (n=189,192) | 1.03 units on a scale | Standard Deviation 1.48 |
Secondary
Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period.
Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseliine (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period. | 0.50 units on a scale | Standard Deviation 1.3 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Concentrate Averaged Over the 12 Week Double Blind Study Period. | 0.96 units on a scale | Standard Deviation 1.25 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points
Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 3 (n=189,191) | 0.36 units on a scale | Standard Deviation 0.88 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 6 (n=189,192) | 0.46 units on a scale | Standard Deviation 1.25 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 9 (n=189,192) | 0.62 units on a scale | Standard Deviation 1.54 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 12 (n=189,192) | 0.69 units on a scale | Standard Deviation 1.68 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 14 (n=189,192) | 0.75 units on a scale | Standard Deviation 1.81 |
| Placebo | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 16 (n=189,192) | 0.69 units on a scale | Standard Deviation 1.87 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 14 (n=189,192) | 0.96 units on a scale | Standard Deviation 1.87 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 3 (n=189,191) | 0.69 units on a scale | Standard Deviation 0.98 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 12 (n=189,192) | 1.08 units on a scale | Standard Deviation 1.6 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 6 (n=189,192) | 0.87 units on a scale | Standard Deviation 1.27 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 16 (n=189,192) | 0.87 units on a scale | Standard Deviation 1.96 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Ability to Function at Various Study Time Points | Week 9 (n=189,192) | 0.98 units on a scale | Standard Deviation 1.5 |
Secondary
Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period
Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period | 0.53 units on a scale | Standard Deviation 1.29 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Ability to Function Averaged Over the 12 Week Double Blind Period | 0.91 units on a scale | Standard Deviation 1.28 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points
Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 3 (n=110,92) | -0.39 number of naps | Standard Deviation 2.04 |
| Placebo | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 6 (n=110,93) | -0.80 number of naps | Standard Deviation 2.49 |
| Placebo | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 9 (n=110, 93) | -0.96 number of naps | Standard Deviation 2.67 |
| Placebo | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 12 (n=110, 93) | -0.96 number of naps | Standard Deviation 2.88 |
| Placebo | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 14 (n=110,93) | -0.71 number of naps | Standard Deviation 2.93 |
| Placebo | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 16 (n=110,93) | -0.92 number of naps | Standard Deviation 2.79 |
| Eszopiclone | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 14 (n=110,93) | -1.00 number of naps | Standard Deviation 2.31 |
| Eszopiclone | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 3 (n=110,92) | -1.15 number of naps | Standard Deviation 2.02 |
| Eszopiclone | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 12 (n=110, 93) | -1.18 number of naps | Standard Deviation 2.58 |
| Eszopiclone | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 6 (n=110,93) | -1.26 number of naps | Standard Deviation 2.21 |
| Eszopiclone | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 16 (n=110,93) | -1.29 number of naps | Standard Deviation 2.49 |
| Eszopiclone | Mean Change From Baseline In Subject-Reported Counts of Number of Naps Per Week at Various Study Time Points | Week 9 (n=110, 93) | -1.33 number of naps | Standard Deviation 2.51 |
Secondary
Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period
Change from baseline in the number of naps per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose)- week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period | -0.78 number of naps | Standard Deviation 2.3 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Counts of Number of Naps Per Week Averaged Over the 12 Week Double Blind Study Period | -1.23 number of naps | Standard Deviation 2.11 |
p-value: 0.1175ANCOVA
Secondary
Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points
Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 3 (n=189,191) | 0.39 units on a scale | Standard Deviation 0.9 |
| Placebo | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 6 (n=189,192) | 0.55 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 9 (n=189,192) | 0.72 units on a scale | Standard Deviation 1.53 |
| Placebo | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 12 (n=189,192) | 0.78 units on a scale | Standard Deviation 1.72 |
| Placebo | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 14 (n=189,192) | 0.85 units on a scale | Standard Deviation 1.81 |
| Placebo | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 16 (n=189,192) | 0.78 units on a scale | Standard Deviation 1.89 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 14 (n=189,192) | 1.05 units on a scale | Standard Deviation 1.92 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 3 (n=189,191) | 0.76 units on a scale | Standard Deviation 1.03 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 12 (n=189,192) | 1.21 units on a scale | Standard Deviation 1.64 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 6 (n=189,192) | 0.99 units on a scale | Standard Deviation 1.29 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 16 (n=189,192) | 0.97 units on a scale | Standard Deviation 2 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Daytime Alertness at Various Study Time Points | Week 9 (n=189,192) | 1.10 units on a scale | Standard Deviation 1.54 |
Secondary
Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points
Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 3 (n=188, 190) | 0.40 units on a scale | Standard Deviation 0.97 |
| Placebo | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 6 (n=189, 191) | 0.62 units on a scale | Standard Deviation 1.29 |
| Placebo | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 9 (n=189, 191) | 0.82 units on a scale | Standard Deviation 1.54 |
| Placebo | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 12 (n=189, 191) | 0.93 units on a scale | Standard Deviation 1.74 |
| Placebo | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 14 (n=189,191) | 1.00 units on a scale | Standard Deviation 1.88 |
| Placebo | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 16 (n=189,191) | 0.88 units on a scale | Standard Deviation 1.96 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 14 (n=189,191) | 1.23 units on a scale | Standard Deviation 2.08 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 3 (n=188, 190) | 1.07 units on a scale | Standard Deviation 1.16 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 12 (n=189, 191) | 1.49 units on a scale | Standard Deviation 1.73 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 6 (n=189, 191) | 1.30 units on a scale | Standard Deviation 1.44 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 16 (n=189,191) | 1.15 units on a scale | Standard Deviation 2.05 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Depth of Sleep at Various Study Time Points | Week 9 (n=189, 191) | 1.46 units on a scale | Standard Deviation 1.63 |
Secondary
Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period.
Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period. | 0.69 units on a scale | Standard Deviation 1.33 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Depth of Sleep for the Average Reported During the Double-blind Period. | 1.33 units on a scale | Standard Deviation 1.43 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period.
The number of awakenings is the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - Week12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period. | -0.27 number of awakenings | Standard Deviation 0.72 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Number of Awakenings Averaged Over the 12 Week Double Blind Study Period. | -0.56 number of awakenings | Standard Deviation 0.79 |
p-value: 0.0005ANCOVA
Secondary
Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points.
Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 3 (n=189,191) | 0.35 units on a scale | Standard Deviation 0.88 |
| Placebo | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 6 (n=189,192) | 0.46 units on a scale | Standard Deviation 1.26 |
| Placebo | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 9 (n=189,192) | 0.61 units on a scale | Standard Deviation 1.52 |
| Placebo | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 12 (n=189,192) | 0.65 units on a scale | Standard Deviation 1.71 |
| Placebo | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 14 (n=189,192) | 0.72 units on a scale | Standard Deviation 1.82 |
| Placebo | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 16 (n=189,192) | 0.64 units on a scale | Standard Deviation 1.9 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 14 (n=189,192) | 0.89 units on a scale | Standard Deviation 1.92 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 3 (n=189,191) | 0.68 units on a scale | Standard Deviation 0.99 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 12 (n=189,192) | 1.02 units on a scale | Standard Deviation 1.62 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 6 (n=189,192) | 0.84 units on a scale | Standard Deviation 1.27 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 16 (n=189,192) | 0.80 units on a scale | Standard Deviation 1.97 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Physical Well-being at Various Study Time Points. | Week 9 (n=189,192) | 0.93 units on a scale | Standard Deviation 1.51 |
Secondary
Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period
Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period | 0.52 units on a scale | Standard Deviation 1.28 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Physical Well-Being Averaged Over the 12 Week Double Blind Study Period | 0.87 units on a scale | Standard Deviation 1.29 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points.
Sleep quality was rated by subjects on a scale from 0-10, with higher scores representing better quality sleep. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 3 (n=188,190) | 0.37 units on a scale | Standard Deviation 0.98 |
| Placebo | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 6 (n=189,191) | 0.62 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 9 (n=189,191) | 0.81 units on a scale | Standard Deviation 1.58 |
| Placebo | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 12 (n=189,191) | 0.92 units on a scale | Standard Deviation 1.77 |
| Placebo | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 14 (n=189,191) | 1.02 units on a scale | Standard Deviation 1.88 |
| Placebo | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 16 (n=189, 191) | 0.88 units on a scale | Standard Deviation 1.96 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 14 (n=189,191) | 1.26 units on a scale | Standard Deviation 2.07 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 3 (n=188,190) | 1.12 units on a scale | Standard Deviation 1.18 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 12 (n=189,191) | 1.57 units on a scale | Standard Deviation 1.73 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 6 (n=189,191) | 1.35 units on a scale | Standard Deviation 1.43 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 16 (n=189, 191) | 1.22 units on a scale | Standard Deviation 2.06 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Quality of Sleep at Various Study Time Points. | Week 9 (n=189,191) | 1.52 units on a scale | Standard Deviation 1.62 |
Secondary
Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period
Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - Week12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period | 0.68 units on a scale | Standard Deviation 1.35 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Quality of Sleep Averaged Over the 12 Week Double Blind Study Period | 1.39 units on a scale | Standard Deviation 1.43 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points
Sleep latency answers the question: How long did it take you to fall asleep last night? The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 6 (n=191,191) | -19.69 minutes | Standard Deviation 52.08 |
| Placebo | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 12 (n=191,191) | -23.54 minutes | Standard Deviation 54.14 |
| Placebo | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 3 (n=191,190) | -13.34 minutes | Standard Deviation 41.97 |
| Placebo | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 14 (n=191,191) | -25.08 minutes | Standard Deviation 58.99 |
| Placebo | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 9 (n=191,191) | -23.02 minutes | Standard Deviation 50.75 |
| Placebo | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 16 (n=191,191) | -24.61 minutes | Standard Deviation 55.22 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 9 (n=191,191) | -24.21 minutes | Standard Deviation 52.62 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 3 (n=191,190) | -21.89 minutes | Standard Deviation 44.38 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 6 (n=191,191) | -24.13 minutes | Standard Deviation 49.2 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 16 (n=191,191) | -18.73 minutes | Standard Deviation 51.67 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 12 (n=191,191) | -28.35 minutes | Standard Deviation 49.72 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Sleep Latency at Various Study Time Points | Week 14 (n=191,191) | -17.00 minutes | Standard Deviation 55.55 |
Secondary
Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period.
Sleep latency answers how long it takes to fall asleep. The difference between the sleep latency at baseline and the average sleep latency over the double blind period(average of post-dose values from weeks 3,6,9,12) reported by the participant. The change is calculated as the average over the double blind period minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - Week12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period. | -19.92 minutes | Standard Deviation 46.99 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Sleep Latency (SL) Averaged Over the 12 Week Double Blind Period. | -24.62 minutes | Standard Deviation 46.32 |
p-value: 0.0014ANCOVA
Secondary
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period
Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period | -2.44 percentage of total asleep time | Standard Deviation 8.29 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week as a Percent of Total Asleep Time Averaged Over the 12 Week Double Blind Study Period | -2.98 percentage of total asleep time | Standard Deviation 5.53 |
p-value: 0.1182ANCOVA
Secondary
Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points.
Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 3 (n=110,92) | -21.66 minutes | Standard Deviation 116.53 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 6 (n=110,93) | -40.02 minutes | Standard Deviation 140.47 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 9 (n=110,93) | -40.25 minutes | Standard Deviation 146.42 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 12 (n=110,93) | -42.15 minutes | Standard Deviation 136.85 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 14 (n=110,93) | -27.28 minutes | Standard Deviation 142.36 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 16 (n=110,93) | -38.14 minutes | Standard Deviation 137.69 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 14 (n=110,93) | -44.48 minutes | Standard Deviation 165.67 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 3 (n=110,92) | -59.06 minutes | Standard Deviation 158 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 12 (n=110,93) | -58.22 minutes | Standard Deviation 163.87 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 6 (n=110,93) | -65.99 minutes | Standard Deviation 163.12 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 16 (n=110,93) | -49.15 minutes | Standard Deviation 202.13 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Per Week at Various Study Time Points. | Week 9 (n=110,93) | -56.59 minutes | Standard Deviation 184.47 |
Secondary
Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Change from baseline in the total time spent napping per week stated as a percentage of the total time asleep for subjects who napped during the baseline period. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 3 (n=110,92) | -1.78 percentage of total asleep time | Standard Deviation 7 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 6 (n=110,93) | -2.52 percentage of total asleep time | Standard Deviation 9.09 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 9 (n=110,93) | -2.72 percentage of total asleep time | Standard Deviation 9.26 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 12 (n=110,93) | -2.76 percentage of total asleep time | Standard Deviation 8.98 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 14 (n=110,93) | -2.31 percentage of total asleep time | Standard Deviation 9.22 |
| Placebo | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 16 (n=110,93) | -2.55 percentage of total asleep time | Standard Deviation 8.62 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 14 (n=110,93) | -2.14 percentage of total asleep time | Standard Deviation 5.82 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 3 (n=110,92) | -2.77 percentage of total asleep time | Standard Deviation 5.57 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 12 (n=110,93) | -3.04 percentage of total asleep time | Standard Deviation 5.82 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 6 (n=110,93) | -3.16 percentage of total asleep time | Standard Deviation 5.8 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 16 (n=110,93) | -2.38 percentage of total asleep time | Standard Deviation 6.72 |
| Eszopiclone | Mean Change From Baseline in Subject-Reported Total Nap Time Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 9 (n=110,93) | -2.94 percentage of total asleep time | Standard Deviation 6.24 |
Secondary
Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points.
The difference between the total sleep time at baseline and at different time points in the double-blind period (weeks 3,6,9,12), the single-blind follow-up (week 14) and the non-drug treatment follow-up (week 16). The change is calculated as the time point value minus the baseline value.
Time frame: Weeks 0, 3, 6, 9, 12, 14, 16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Change calculated as the post-dose measure minus the baseline measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 3 (n=191,190) | 20.65 minutes | Standard Deviation 42.34 |
| Placebo | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 6 (n=191,191) | 32.47 minutes | Standard Deviation 53.31 |
| Placebo | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 9 (n=191,191) | 38.73 minutes | Standard Deviation 57.73 |
| Placebo | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 12 (n=191,191) | 40.86 minutes | Standard Deviation 60.74 |
| Placebo | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 14 (n=191,191) | 42.78 minutes | Standard Deviation 66.52 |
| Placebo | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 16 (n=191,191) | 37.43 minutes | Standard Deviation 67.68 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 14 (n=191,191) | 50.12 minutes | Standard Deviation 68.25 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 3 (n=191,190) | 51.02 minutes | Standard Deviation 46.43 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 12 (n=191,191) | 70.97 minutes | Standard Deviation 62.18 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 6 (n=191,191) | 61.91 minutes | Standard Deviation 54.15 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 16 (n=191,191) | 47.17 minutes | Standard Deviation 63.68 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Total Sleep Time at Various Study Time Points. | Week 9 (n=191,191) | 69.00 minutes | Standard Deviation 61.58 |
Secondary
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points.
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 3 (n=188,190) | -8.55 minutes | Standard Deviation 35.8 |
| Placebo | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 6 (n=189,191) | -13.46 minutes | Standard Deviation 39.01 |
| Placebo | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 9 (n=189,191) | -17.67 minutes | Standard Deviation 44.13 |
| Placebo | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 12 (n=189,191) | -19.13 minutes | Standard Deviation 43.39 |
| Placebo | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 14 (n=189,191) | -22.72 minutes | Standard Deviation 45 |
| Placebo | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 16 (n=189,191) | -20.18 minutes | Standard Deviation 48.06 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 14 (n=189,191) | -32.27 minutes | Standard Deviation 47.55 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 3 (n=188,190) | -29.26 minutes | Standard Deviation 37.68 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 12 (n=189,191) | -39.61 minutes | Standard Deviation 46.48 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 6 (n=189,191) | -36.57 minutes | Standard Deviation 43.11 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 16 (n=189,191) | -31.13 minutes | Standard Deviation 51.35 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points. | Week 9 (n=189,191) | -40.32 minutes | Standard Deviation 45.12 |
Secondary
Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period.
Wake time after sleep onset (WASO) is the time spent awake from sleep onset to final awakening. The difference between WASO at baseline and the average WASO over the double blind period(average of post-dose values from weeks 3,6,9,12). The change is calculated as the average over the double blind period minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) -week 12
Population: Intent to treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last observation carried forward (LOCF). Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period. | -14.75 minutes | Standard Deviation 38.45 |
| Eszopiclone | Mean Change From Baseline in Subject-reported Wake Time After Sleep Onset (WASO) Averaged Over the 12 Week Double-blind Study Period. | -36.40 minutes | Standard Deviation 41.29 |
p-value: <0.0001ANCOVA
Secondary
Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points.
Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 1 (n=59,58) | 0.76 number of awakenings | Standard Deviation 3.09 |
| Placebo | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 4 (n=61,61) | 0.79 number of awakenings | Standard Deviation 4.62 |
| Placebo | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 7 (n=62,61) | 0.88 number of awakenings | Standard Deviation 4.73 |
| Placebo | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 12 (n=62,61) | 0.95 number of awakenings | Standard Deviation 4.6 |
| Placebo | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 13 (n=62,61) | 1.10 number of awakenings | Standard Deviation 4.69 |
| Placebo | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 15 (n=62,61) | 1.36 number of awakenings | Standard Deviation 4.35 |
| Eszopiclone | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 13 (n=62,61) | 0.01 number of awakenings | Standard Deviation 4.93 |
| Eszopiclone | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 1 (n=59,58) | -0.54 number of awakenings | Standard Deviation 4.19 |
| Eszopiclone | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 12 (n=62,61) | -0.10 number of awakenings | Standard Deviation 4.93 |
| Eszopiclone | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 4 (n=61,61) | 0.04 number of awakenings | Standard Deviation 5.22 |
| Eszopiclone | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 15 (n=62,61) | -0.13 number of awakenings | Standard Deviation 5.02 |
| Eszopiclone | Mean Change From Baseline in the Number of Awakenings Measured Using Actigraphy at Various Study Time Points. | Week 7 (n=62,61) | -0.21 number of awakenings | Standard Deviation 5.05 |
Secondary
Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
Change from baseline in the number of naps per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 1.33 number of naps | Standard Deviation 9.15 |
| Placebo | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 7 (n=58,58) | 1.68 number of naps | Standard Deviation 10.63 |
| Placebo | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 4 (n=57,58) | 1.02 number of naps | Standard Deviation 11.73 |
| Placebo | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 12 (n=58,58) | 1.86 number of naps | Standard Deviation 9.83 |
| Placebo | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 13 (n=58,58) | 2.73 number of naps | Standard Deviation 10.54 |
| Placebo | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 15 (n=58,58) | 3.41 number of naps | Standard Deviation 11.22 |
| Eszopiclone | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 13 (n=58,58) | -4.58 number of naps | Standard Deviation 13.69 |
| Eszopiclone | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 12 (n=58,58) | -3.47 number of naps | Standard Deviation 15.15 |
| Eszopiclone | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 1 (n=57,55) | -0.62 number of naps | Standard Deviation 12.92 |
| Eszopiclone | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 15 (n=58,58) | -0.64 number of naps | Standard Deviation 12.16 |
| Eszopiclone | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 4 (n=57,58) | -3.43 number of naps | Standard Deviation 13.36 |
| Eszopiclone | Mean Change From Baseline in the Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 7 (n=58,58) | -2.83 number of naps | Standard Deviation 16.76 |
Secondary
Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points.
The number of awakenings refers to the number of times a subject wakes up between the initial onset of sleep and the final awakening. The change is calculated as value during double-blind phase(weeks 3,6,9,12), or the single-blind follow-up(week 14), or the non-drug treatment follow-up(week 16) minus the baseline value.
Time frame: Baseline (week 0), Weeks 3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 3 (n=188,190) | -0.16 number of awakenings | Standard Deviation 0.63 |
| Placebo | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 6 (n=189,191) | -0.24 number of awakenings | Standard Deviation 0.77 |
| Placebo | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 9 (n=189,191) | -0.33 number of awakenings | Standard Deviation 0.81 |
| Placebo | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 12 (n=189,191) | -0.35 number of awakenings | Standard Deviation 0.83 |
| Placebo | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 14 (n=189,191) | -0.38 number of awakenings | Standard Deviation 0.85 |
| Placebo | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 16 (n=189,191) | -0.35 number of awakenings | Standard Deviation 0.87 |
| Eszopiclone | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 14 (n=189,191) | -0.46 number of awakenings | Standard Deviation 0.96 |
| Eszopiclone | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 3 (n=188,190) | -0.46 number of awakenings | Standard Deviation 0.7 |
| Eszopiclone | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 12 (n=189,191) | -0.65 number of awakenings | Standard Deviation 0.9 |
| Eszopiclone | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 6 (n=189,191) | -0.56 number of awakenings | Standard Deviation 0.83 |
| Eszopiclone | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 16 (n=189,191) | -0.44 number of awakenings | Standard Deviation 0.97 |
| Eszopiclone | Mean Change From Baseline in the Number of Subject-reported Awakenings at Various Study Time Points. | Week 9 (n=189,191) | -0.57 number of awakenings | Standard Deviation 0.88 |
Secondary
Mean Change From Baseline in the Sheehan Disability Scale Total Score.
Sheehan Disability Scale Total Score (range 0-30)measures subject's level of disability & includes: work/school, social life, family life/home responsibilities, days lost &days underproductive; higher scores represent higher degree of disability/impairment. Change is calculated as time point value minus baseline value.
Time frame: Baseline (week 0), Weeks 6,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 6 (n=164,165) | -2.60 units on a scale | Standard Deviation 7.63 |
| Placebo | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 12 (n=165,166) | -3.73 units on a scale | Standard Deviation 7.59 |
| Placebo | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 14 (n=166,166) | -3.11 units on a scale | Standard Deviation 7.88 |
| Placebo | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 16 (n=166,166) | -3.33 units on a scale | Standard Deviation 8.09 |
| Eszopiclone | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 16 (n=166,166) | -2.47 units on a scale | Standard Deviation 7.14 |
| Eszopiclone | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 6 (n=164,165) | -4.05 units on a scale | Standard Deviation 7.42 |
| Eszopiclone | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 14 (n=166,166) | -3.52 units on a scale | Standard Deviation 7.15 |
| Eszopiclone | Mean Change From Baseline in the Sheehan Disability Scale Total Score. | Week 12 (n=165,166) | -4.48 units on a scale | Standard Deviation 7.72 |
Secondary
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points
Change from baseline in total time spent napping per week as a percent of total time asleep for subjects who napped during the baseline period. Change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 1.38 percentage of total asleep time | Standard Deviation 13.89 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 4 (n=57,58) | -0.56 percentage of total asleep time | Standard Deviation 8.64 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 7 (n=58,58) | 0.18 percentage of total asleep time | Standard Deviation 9.21 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 12 (n=58,58) | 0.46 percentage of total asleep time | Standard Deviation 7.76 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 13 (n=58,58) | 0.94 percentage of total asleep time | Standard Deviation 7.96 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 15 (n=58,58) | 0.95 percentage of total asleep time | Standard Deviation 8.11 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 13 (n=58,58) | -2.63 percentage of total asleep time | Standard Deviation 8.98 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 1 (n=57,55) | -0.17 percentage of total asleep time | Standard Deviation 7.95 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 12 (n=58,58) | -2.70 percentage of total asleep time | Standard Deviation 9.24 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 4 (n=57,58) | -2.14 percentage of total asleep time | Standard Deviation 9.54 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 15 (n=58,58) | -0.04 percentage of total asleep time | Standard Deviation 7.41 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time as Measured by Actigraphy at Various Study Time Points | Week 7 (n=58,58) | -1.75 percentage of total asleep time | Standard Deviation 11.22 |
Secondary
Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period.
Change from baseline in the total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period. | 0.45 percentage of total asleep time | Standard Deviation 7.84 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week as a Percentage of Total Asleep Time Measured by Actigraphy and Averaged Over the 12 Week Double Blind Study Period. | -1.75 percentage of total asleep time | Standard Deviation 8.46 |
p-value: 0.0634ANCOVA
Secondary
Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points
Change from baseline in the total nap time per week for subjects who napped during the baseline period. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 12 (n=58,58) | 38.86 minutes | Standard Deviation 229.45 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 2.37 minutes | Standard Deviation 184.85 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 13 (n=58,58) | 64.84 minutes | Standard Deviation 275.99 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 7 (n=58,58) | 23.03 minutes | Standard Deviation 220.2 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 15 (n=58,58) | 61.28 minutes | Standard Deviation 235.24 |
| Placebo | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 4 (n=57,58) | 6.37 minutes | Standard Deviation 252.54 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 15 (n=58,58) | -1.99 minutes | Standard Deviation 240.85 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 4 (n=57,58) | -56.87 minutes | Standard Deviation 336.01 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 7 (n=58,58) | -31.85 minutes | Standard Deviation 428.85 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 12 (n=58,58) | -73.67 minutes | Standard Deviation 338.69 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 13 (n=58,58) | -87.50 minutes | Standard Deviation 291.01 |
| Eszopiclone | Mean Change From Baseline in Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 6.56 minutes | Standard Deviation 285.45 |
Secondary
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points
Change from baseline in total sleep time for the subset population who wore an actigraph wrist monitor. The actigraph monitors rest and activity cycles; the resultant data had sleep parameters calculated by a Central Reader. The change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 1 (n=60,58) | 3.72 minutes | Standard Deviation 54.09 |
| Placebo | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 4 (n=61,61) | 17.21 minutes | Standard Deviation 39.97 |
| Placebo | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 7 (n=62,61) | 15.72 minutes | Standard Deviation 57.85 |
| Placebo | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 12 (n=62,61) | 18.93 minutes | Standard Deviation 44.73 |
| Placebo | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 13 (n=62,61) | 15.36 minutes | Standard Deviation 51.72 |
| Placebo | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 15 (n=62,61) | 13.82 minutes | Standard Deviation 43.48 |
| Eszopiclone | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 13 (n=62,61) | -0.60 minutes | Standard Deviation 56.17 |
| Eszopiclone | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 1 (n=60,58) | 14.97 minutes | Standard Deviation 36.91 |
| Eszopiclone | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 12 (n=62,61) | 18.08 minutes | Standard Deviation 52.57 |
| Eszopiclone | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 4 (n=61,61) | 16.89 minutes | Standard Deviation 41 |
| Eszopiclone | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 15 (n=62,61) | 4.06 minutes | Standard Deviation 47.6 |
| Eszopiclone | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 7 (n=62,61) | 22.12 minutes | Standard Deviation 41.02 |
Secondary
Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
Participants who wore an actigraph wrist monitor, which monitors rest and activity cycles are included; the resultant data had total sleep time calculated by a Central Reader. The change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | 14.40 minutes | Standard Deviation 38.14 |
| Eszopiclone | Mean Change From Baseline in Total Sleep Time Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | 17.96 minutes | Standard Deviation 34.71 |
p-value: 0.301ANCOVA
Secondary
Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Participants who wore an actigraph wrist monitor to record rest and activity cycles are included; a Central Reader calculated sleep parameters. The change is calculated as time point value minus the baseline value.
Time frame: Baseline (week 0), Weeks 1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 1 (n=59,58) | 3.17 minutes | Standard Deviation 16.23 |
| Placebo | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 4 (n=61,61) | 4.67 minutes | Standard Deviation 23.36 |
| Placebo | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 7 (n=62,61) | 6.57 minutes | Standard Deviation 30.27 |
| Placebo | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 12 (n=62,61) | 3.24 minutes | Standard Deviation 17.9 |
| Placebo | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 13 (n=62,61) | 4.98 minutes | Standard Deviation 22.35 |
| Placebo | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 15 (n=62,61) | 7.74 minutes | Standard Deviation 25.7 |
| Eszopiclone | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 13 (n=62,61) | 0.68 minutes | Standard Deviation 23.79 |
| Eszopiclone | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 1 (n=59,58) | -6.59 minutes | Standard Deviation 23.78 |
| Eszopiclone | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 12 (n=62,61) | -2.54 minutes | Standard Deviation 24.42 |
| Eszopiclone | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 4 (n=61,61) | -3.88 minutes | Standard Deviation 26.95 |
| Eszopiclone | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 15 (n=62,61) | -0.27 minutes | Standard Deviation 24.1 |
| Eszopiclone | Mean Change From Baseline in Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 7 (n=62,61) | -4.19 minutes | Standard Deviation 25.25 |
Secondary
Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Change is calculated as average over double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | 4.50 minutes | Standard Deviation 19.54 |
| Eszopiclone | Mean Change From Baseline in Wake Time After Sleep Onset (WASO) Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | -4.24 minutes | Standard Deviation 22.91 |
p-value: 0.0803ANCOVA
Secondary
Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period
Change from baseline in the total nap time per week for subjects who napped during the baseline period. Change is calculated as the average over the double blind period (average of post-dose values from weeks 1,4,7,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.Actigraphy population N=72,69.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | 21.26 minutes | Standard Deviation 196.66 |
| Eszopiclone | Mean Change From Baseline Total Nap Time Per Week Measured by Actigraphy Averaged Over the 12 Week Double Blind Study Period | -40.91 minutes | Standard Deviation 307.98 |
p-value: 0.2967ANCOVA
Secondary
Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period
Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period | 0.61 units on a scale | Standard Deviation 1.3 |
| Eszopiclone | Mean Change in Subject-reported Daytime Alertness Averaged Over the 12 Week Double Blind Study Period | 1.02 units on a scale | Standard Deviation 1.31 |
p-value: <0.0001ANCOVA
Secondary
Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period
Change from baseline in the total time (minutes) spent napping per week for subjects who napped during the baseline period. The change is calculated as the average over the double blind period (average of post-dose values from weeks 3,6,9,12) minus the baseline value.
Time frame: Baseline (week 0), Day 1 (post first dose) - week 12
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward. Number of participants in each arm 194, 194.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period | -36.02 minutes | Standard Deviation 125.59 |
| Eszopiclone | Mean Change in Subject-Reported Total Nap Time Per Week Averaged Over the 12 Week Double Blind Study Period | -60.06 minutes | Standard Deviation 156.49 |
p-value: 0.0717ANCOVA
Secondary
Mean Insomnia Severity Index Total Scores at Various Study Time Points
The Insomnia Severity Index Total Score ranges from 0-28. Lower scores represent better sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 0 (n=192,190) | 16.34 units on a scale | Standard Deviation 4.18 |
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 3 (n=180,183) | 13.52 units on a scale | Standard Deviation 5.11 |
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 6 (n=181,184) | 12.87 units on a scale | Standard Deviation 5.26 |
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 9 (n=181,185) | 12.66 units on a scale | Standard Deviation 5.58 |
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 12 (n=181,185) | 12.16 units on a scale | Standard Deviation 5.51 |
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=181,185) | 12.80 units on a scale | Standard Deviation 4.87 |
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 14 (n=182,185) | 12.30 units on a scale | Standard Deviation 5.68 |
| Placebo | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 16 (n=182,185) | 13.28 units on a scale | Standard Deviation 5.39 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 16 (n=182,185) | 13.05 units on a scale | Standard Deviation 5.49 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 0 (n=192,190) | 16.12 units on a scale | Standard Deviation 4.81 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 12 (n=181,185) | 9.84 units on a scale | Standard Deviation 5.63 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 3 (n=180,183) | 11.09 units on a scale | Standard Deviation 5.48 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 14 (n=182,185) | 11.94 units on a scale | Standard Deviation 5.56 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 6 (n=181,184) | 10.40 units on a scale | Standard Deviation 5.87 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=181,185) | 10.36 units on a scale | Standard Deviation 5.16 |
| Eszopiclone | Mean Insomnia Severity Index Total Scores at Various Study Time Points | Week 9 (n=181,185) | 10.12 units on a scale | Standard Deviation 5.77 |
Secondary
Mean Mental Component Summary of the Short Form-36 Scale Scores
This scale measures subject's perception of their physical health, where normal mean for general US population is 50. Scores above/below 50 represent better/worse than general US population. Change calculated: time point value minus baseline value. Mean values: baseline(week0), double-blind phase(weeks 6,12)& non-drug treatment follow-up(week 16).
Time frame: Weeks 0,6,12,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 0 (n=192,190) | 49.69 units on a scale | Standard Deviation 9.33 |
| Placebo | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 6 (n=165,168) | 49.49 units on a scale | Standard Deviation 10.03 |
| Placebo | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 12 (n=166,169) | 48.98 units on a scale | Standard Deviation 10.19 |
| Placebo | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 16 (n=167,169) | 48.68 units on a scale | Standard Deviation 10.61 |
| Eszopiclone | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 16 (n=167,169) | 49.23 units on a scale | Standard Deviation 9.92 |
| Eszopiclone | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 0 (n=192,190) | 49.29 units on a scale | Standard Deviation 10.04 |
| Eszopiclone | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 12 (n=166,169) | 49.86 units on a scale | Standard Deviation 9.09 |
| Eszopiclone | Mean Mental Component Summary of the Short Form-36 Scale Scores | Week 6 (n=165,168) | 49.96 units on a scale | Standard Deviation 10.03 |
Secondary
Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points
Number of awakenings refers to the number of times a subject awakens between first sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Time frame: Weeks 0,1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 0 (n=64,61) | 21.49 number of awakenings | Standard Deviation 7.53 |
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 1 (n=63,64) | 22.42 number of awakenings | Standard Deviation 7.17 |
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 4 (n=67,67) | 22.28 number of awakenings | Standard Deviation 7.3 |
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 7 (n=68,67) | 22.52 number of awakenings | Standard Deviation 7.93 |
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 12 (n=68,67) | 22.36 number of awakenings | Standard Deviation 7.76 |
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=68,67) | 22.40 number of awakenings | Standard Deviation 7.15 |
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 13 (n=68,67) | 22.55 number of awakenings | Standard Deviation 7.57 |
| Placebo | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 15 (n=68,67) | 22.87 number of awakenings | Standard Deviation 7.71 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 15 (n=68,67) | 22.38 number of awakenings | Standard Deviation 5.99 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 0 (n=64,61) | 22.84 number of awakenings | Standard Deviation 6.94 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 12 (n=68,67) | 22.37 number of awakenings | Standard Deviation 6.25 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 1 (n=63,64) | 21.86 number of awakenings | Standard Deviation 5.96 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 13 (n=68,67) | 22.48 number of awakenings | Standard Deviation 7.3 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 4 (n=67,67) | 22.51 number of awakenings | Standard Deviation 6.16 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=68,67) | 22.27 number of awakenings | Standard Deviation 5.66 |
| Eszopiclone | Mean Number of Awakenings Measured Using Actigraphy at Various Study Time Points | Week 7 (n=68,67) | 22.19 number of awakenings | Standard Deviation 6.08 |
Secondary
Mean Number of Awakenings (Subject-reported) at Various Study Time Points
Number of awakenings is number of times a subject wakes up between initial onset of sleep and final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 0 (n=190,191) | 1.95 number of awakenings | Standard Deviation 1 |
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 3 (n=190,192) | 1.78 number of awakenings | Standard Deviation 0.91 |
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 6 (n=192,193) | 1.72 number of awakenings | Standard Deviation 0.93 |
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 9 (n=192,193) | 1.62 number of awakenings | Standard Deviation 0.94 |
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 12 (n=192,193) | 1.61 number of awakenings | Standard Deviation 0.94 |
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192,193) | 1.68 number of awakenings | Standard Deviation 0.9 |
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 14 (n=192,193) | 1.58 number of awakenings | Standard Deviation 0.99 |
| Placebo | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 16 (n=192,193) | 1.61 number of awakenings | Standard Deviation 0.97 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 16 (n=192,193) | 1.66 number of awakenings | Standard Deviation 1.11 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 0 (n=190,191) | 2.10 number of awakenings | Standard Deviation 1.1 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 12 (n=192,193) | 1.46 number of awakenings | Standard Deviation 1.03 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 3 (n=190,192) | 1.66 number of awakenings | Standard Deviation 0.96 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 14 (n=192,193) | 1.65 number of awakenings | Standard Deviation 1.15 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 6 (n=192,193) | 1.55 number of awakenings | Standard Deviation 1 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192,193) | 1.55 number of awakenings | Standard Deviation 0.97 |
| Eszopiclone | Mean Number of Awakenings (Subject-reported) at Various Study Time Points | Week 9 (n=192,193) | 1.54 number of awakenings | Standard Deviation 1.01 |
Secondary
Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points
The number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Time frame: Week 0,1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 0 (n=62,58) | 20.52 number of naps | Standard Deviation 15.63 |
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 20.94 number of naps | Standard Deviation 14.99 |
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 4 (n=57,58) | 20.63 number of naps | Standard Deviation 15.38 |
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 7 (n=58,58) | 21.07 number of naps | Standard Deviation 14.93 |
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 12 (n=58,58) | 21.25 number of naps | Standard Deviation 14.29 |
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=58,58) | 21.01 number of naps | Standard Deviation 13.9 |
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 13 (n=58,58) | 22.12 number of naps | Standard Deviation 15.97 |
| Placebo | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 15 (n=58,58) | 22.80 number of naps | Standard Deviation 15.03 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 15 (n=58,58) | 21.69 number of naps | Standard Deviation 14.45 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 0 (n=62,58) | 22.33 number of naps | Standard Deviation 15.42 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 12 (n=58,58) | 18.86 number of naps | Standard Deviation 15.18 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 21.69 number of naps | Standard Deviation 15.38 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 13 (n=58,58) | 17.75 number of naps | Standard Deviation 12.66 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 4 (n=57,58) | 18.90 number of naps | Standard Deviation 13.85 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=58,58) | 19.66 number of naps | Standard Deviation 12.91 |
| Eszopiclone | Mean Number of Naps Per Week Measured Using Actigraphy at Various Study Time Points | Week 7 (n=58,58) | 19.50 number of naps | Standard Deviation 15.18 |
Secondary
Mean Physical Component Summary of the Short Form-36 Scale Scores.
This scale measures subject's perception of their physical health, where the normal mean for general US population is 50.Scores above/below 50 represent better/worse than general US population. Change calculated as time point value minus baseline value: baseline(week0), double-blind (weeks 6,12)and non-drug treatment follow-up(week16).
Time frame: Weeks 0,6,12,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 0 (n=192,190) | 43.99 units on a scale | Standard Deviation 10.67 |
| Placebo | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 6 (n=165,168) | 45.06 units on a scale | Standard Deviation 10.98 |
| Placebo | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 12 (n=166,169) | 45.38 units on a scale | Standard Deviation 10.57 |
| Placebo | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 16 (n=167,169) | 44.70 units on a scale | Standard Deviation 10.98 |
| Eszopiclone | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 16 (n=167,169) | 45.51 units on a scale | Standard Deviation 9.8 |
| Eszopiclone | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 0 (n=192,190) | 45.39 units on a scale | Standard Deviation 9.78 |
| Eszopiclone | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 12 (n=166,169) | 46.12 units on a scale | Standard Deviation 9.42 |
| Eszopiclone | Mean Physical Component Summary of the Short Form-36 Scale Scores. | Week 6 (n=165,168) | 46.08 units on a scale | Standard Deviation 10 |
Secondary
Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points
Quality of sleep was rated by participants on a scale of 0-10, with higher scores representing better quality sleep. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 0 (n=190,191) | 4.84 units on a scale | Standard Deviation 1.83 |
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 3 (n=190,190) | 5.22 units on a scale | Standard Deviation 1.62 |
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 6 (n=192,193) | 5.48 units on a scale | Standard Deviation 1.56 |
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 9 (n=192,193) | 5.67 units on a scale | Standard Deviation 1.57 |
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 12 (n=192,193) | 5.78 units on a scale | Standard Deviation 1.58 |
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192, 193) | 5.54 units on a scale | Standard Deviation 1.5 |
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 14 (n=192,193) | 5.88 units on a scale | Standard Deviation 1.6 |
| Placebo | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 16 (n=192,193) | 5.73 units on a scale | Standard Deviation 1.65 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 16 (n=192,193) | 5.88 units on a scale | Standard Deviation 1.75 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 0 (n=190,191) | 4.68 units on a scale | Standard Deviation 1.94 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 12 (n=192,193) | 6.22 units on a scale | Standard Deviation 1.7 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 3 (n=190,190) | 5.77 units on a scale | Standard Deviation 1.82 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 14 (n=192,193) | 5.91 units on a scale | Standard Deviation 1.76 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 6 (n=192,193) | 6.01 units on a scale | Standard Deviation 1.77 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192, 193) | 6.04 units on a scale | Standard Deviation 1.68 |
| Eszopiclone | Mean Ratings of Subject-reported Quality of Sleep at Various Study Time Points | Week 9 (n=192,193) | 6.17 units on a scale | Standard Deviation 1.71 |
Secondary
Mean Sheehan Disability Total Scores
Sheehan Disability Scale Total Score (range 0-30) measures subject's level of disability; includes work/school, social life, family life/home responsibilities, days lost, days underproductive; higher scores represent higher degree of disability/impairment. Mean values reported: baseline, double-blind(weeks 6,12)& follow-up(weeks 14,16).
Time frame: Weeks 0,6,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Sheehan Disability Total Scores | Week 0 (n=192,190) | 11.38 units on a scale | Standard Deviation 7.8 |
| Placebo | Mean Sheehan Disability Total Scores | Week 12 (n=166,169) | 7.70 units on a scale | Standard Deviation 6.48 |
| Placebo | Mean Sheehan Disability Total Scores | Week 16 (n=167,169) | 8.12 units on a scale | Standard Deviation 7.1 |
| Placebo | Mean Sheehan Disability Total Scores | Week 14 (n=166,166) | 8.37 units on a scale | Standard Deviation 7.21 |
| Placebo | Mean Sheehan Disability Total Scores | Week 6 (n=165,168) | 8.87 units on a scale | Standard Deviation 6.82 |
| Eszopiclone | Mean Sheehan Disability Total Scores | Week 16 (n=167,169) | 9.06 units on a scale | Standard Deviation 7.71 |
| Eszopiclone | Mean Sheehan Disability Total Scores | Week 0 (n=192,190) | 11.13 units on a scale | Standard Deviation 7.63 |
| Eszopiclone | Mean Sheehan Disability Total Scores | Week 6 (n=165,168) | 7.52 units on a scale | Standard Deviation 6.81 |
| Eszopiclone | Mean Sheehan Disability Total Scores | Week 12 (n=166,169) | 7.08 units on a scale | Standard Deviation 6.85 |
| Eszopiclone | Mean Sheehan Disability Total Scores | Week 14 (n=166,166) | 8.03 units on a scale | Standard Deviation 7.1 |
Secondary
Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points.
Sleep latency:measurement of time to fall asleep. Values are for subset who wore an actigraph wrist monitor which monitors rest and activity cycles; sleep parameters calculated by Central Reader.
Time frame: Weeks 0,1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. Mean values reported:baseline(week0), double-blind (weeks 1,4,7,12), single-blind follow-up(week13), non-drug treatment follow-up(week15) \& average for double-blind (average of weeks 1,4,7,12 values). Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 12 (n=68,67) | 27.89 minutes | Standard Deviation 38.78 |
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 0 (n=64,61) | 31.34 minutes | Standard Deviation 65.06 |
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Weeks 1,4,7,12 (double blind average)(n=68,67) | 31.20 minutes | Standard Deviation 36.89 |
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 4 (n=67,67) | 28.55 minutes | Standard Deviation 35.46 |
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 13 (n=68,67) | 30.40 minutes | Standard Deviation 41.05 |
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 7 (n=68,67) | 31.06 minutes | Standard Deviation 42.82 |
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 15 (n=68,67) | 28.80 minutes | Standard Deviation 37.75 |
| Placebo | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 1 (n=64,64) | 37.74 minutes | Standard Deviation 78.14 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 15 (n=68,67) | 34.35 minutes | Standard Deviation 40.34 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 0 (n=64,61) | 23.89 minutes | Standard Deviation 24.5 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 1 (n=64,64) | 26.72 minutes | Standard Deviation 36.56 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 7 (n=68,67) | 26.89 minutes | Standard Deviation 33.34 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 12 (n=68,67) | 36.93 minutes | Standard Deviation 57.69 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Weeks 1,4,7,12 (double blind average)(n=68,67) | 29.22 minutes | Standard Deviation 35.92 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 13 (n=68,67) | 43.06 minutes | Standard Deviation 64.37 |
| Eszopiclone | Mean Sleep Latency Values Measured Using Actigraphy at Various Study Time Points. | Week 4 (n=67,67) | 26.62 minutes | Standard Deviation 43.36 |
Secondary
Mean Subject-reported Ability to Concentrate at Various Study Time Points
Ability to concentrate was rated by study participants on a scale of 0-10, with higher scores representing better concentration. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 0 (n=192,193) | 5.66 units on a scale | Standard Deviation 2.08 |
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 3 (n=190,191) | 5.99 units on a scale | Standard Deviation 1.78 |
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 6 (n=190,192) | 6.10 units on a scale | Standard Deviation 1.62 |
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 9 (n=190,192) | 6.27 units on a scale | Standard Deviation 1.54 |
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 12 (n=190,192) | 6.33 units on a scale | Standard Deviation 1.52 |
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=190,192) | 6.17 units on a scale | Standard Deviation 1.54 |
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 14 (n=190,192) | 6.39 units on a scale | Standard Deviation 1.53 |
| Placebo | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 16 (n=190,192) | 6.33 units on a scale | Standard Deviation 1.61 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 16 (n=190,192) | 6.56 units on a scale | Standard Deviation 1.59 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 0 (n=192,193) | 5.63 units on a scale | Standard Deviation 2.15 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 12 (n=190,192) | 6.77 units on a scale | Standard Deviation 1.57 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 3 (n=190,191) | 6.37 units on a scale | Standard Deviation 1.8 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 14 (n=190,192) | 6.64 units on a scale | Standard Deviation 1.58 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 6 (n=190,192) | 6.57 units on a scale | Standard Deviation 1.69 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=190,192) | 6.60 units on a scale | Standard Deviation 1.6 |
| Eszopiclone | Mean Subject-reported Ability to Concentrate at Various Study Time Points | Week 9 (n=190,192) | 6.67 units on a scale | Standard Deviation 1.58 |
Secondary
Mean Subject-reported Ability to Function at Various Study Time Points
Ability to function was rated by study participants on a scale of 0-10, with higher scores representing better ability to function. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16) & average for double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Week 0 (n=192,193) | 5.62 units on a scale | Standard Deviation 2.07 |
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Week 3 (n=190,191) | 5.98 units on a scale | Standard Deviation 1.79 |
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Week 6 (n=190,192) | 6.09 units on a scale | Standard Deviation 1.61 |
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Week 9 (n=190,192) | 6.24 units on a scale | Standard Deviation 1.56 |
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Week 12 (n=190,192) | 6.32 units on a scale | Standard Deviation 1.54 |
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=190,192) | 6.16 units on a scale | Standard Deviation 1.55 |
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Week 14 (n=190,192) | 6.38 units on a scale | Standard Deviation 1.54 |
| Placebo | Mean Subject-reported Ability to Function at Various Study Time Points | Week 16 (n=190,192) | 6.31 units on a scale | Standard Deviation 1.62 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Week 16 (n=190,192) | 6.57 units on a scale | Standard Deviation 1.57 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Week 0 (n=192,193) | 5.69 units on a scale | Standard Deviation 2.14 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Week 12 (n=190,192) | 6.79 units on a scale | Standard Deviation 1.55 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Week 3 (n=190,191) | 6.38 units on a scale | Standard Deviation 1.79 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Week 14 (n=190,192) | 6.66 units on a scale | Standard Deviation 1.57 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Week 6 (n=190,192) | 6.57 units on a scale | Standard Deviation 1.68 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=190,192) | 6.61 units on a scale | Standard Deviation 1.59 |
| Eszopiclone | Mean Subject-reported Ability to Function at Various Study Time Points | Week 9 (n=190,192) | 6.69 units on a scale | Standard Deviation 1.57 |
Secondary
Mean Subject-reported Daytime Alertness at Various Study Time Points.
Daytime alertness was rated by study participants on a scale of 0-10, with higher scores representing better alertness. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 0 (n=192,193) | 5.34 units on a scale | Standard Deviation 1.97 |
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 3 (n=190,191) | 5.74 units on a scale | Standard Deviation 1.72 |
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 6 (n=190,192) | 5.89 units on a scale | Standard Deviation 1.57 |
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 9 (n=190,192) | 6.06 units on a scale | Standard Deviation 1.51 |
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 12 (n=190,192) | 6.13 units on a scale | Standard Deviation 1.51 |
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=190,192) | 5.95 units on a scale | Standard Deviation 1.5 |
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 14 (n=190,192) | 6.19 units on a scale | Standard Deviation 1.52 |
| Placebo | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 16 (n=190,192) | 6.13 units on a scale | Standard Deviation 1.59 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 16 (n=190,192) | 6.39 units on a scale | Standard Deviation 1.6 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 0 (n=192,193) | 5.42 units on a scale | Standard Deviation 2.11 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 12 (n=190,192) | 6.64 units on a scale | Standard Deviation 1.58 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 3 (n=190,191) | 6.18 units on a scale | Standard Deviation 1.78 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 14 (n=190,192) | 6.47 units on a scale | Standard Deviation 1.63 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 6 (n=190,192) | 6.41 units on a scale | Standard Deviation 1.68 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=190,192) | 6.44 units on a scale | Standard Deviation 1.59 |
| Eszopiclone | Mean Subject-reported Daytime Alertness at Various Study Time Points. | Week 9 (n=190,192) | 6.52 units on a scale | Standard Deviation 1.59 |
Secondary
Mean Subject-reported Depth of Sleep at Various Study Time Points
Depth of sleep was reported by study participants using a scale from 0-10, with higher scores representing better sleep. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 0 (n=190,191) | 4.87 units on a scale | Standard Deviation 1.88 |
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 3 (n=190,192) | 5.29 units on a scale | Standard Deviation 1.62 |
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 6 (n=192,193) | 5.51 units on a scale | Standard Deviation 1.58 |
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 9 (n=192,193) | 5.71 units on a scale | Standard Deviation 1.58 |
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 12 (n=192, 193) | 5.82 units on a scale | Standard Deviation 1.59 |
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192,193) | 5.58 units on a scale | Standard Deviation 1.52 |
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 14 (n=192,193) | 5.89 units on a scale | Standard Deviation 1.63 |
| Placebo | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 16 (n=192,193) | 5.76 units on a scale | Standard Deviation 1.69 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 16 (n=192,193) | 5.84 units on a scale | Standard Deviation 1.76 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 0 (n=190,191) | 4.72 units on a scale | Standard Deviation 1.9 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 12 (n=192, 193) | 6.18 units on a scale | Standard Deviation 1.7 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 3 (n=190,192) | 5.76 units on a scale | Standard Deviation 1.78 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 14 (n=192,193) | 5.92 units on a scale | Standard Deviation 1.78 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 6 (n=192,193) | 6.00 units on a scale | Standard Deviation 1.75 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192,193) | 6.02 units on a scale | Standard Deviation 1.68 |
| Eszopiclone | Mean Subject-reported Depth of Sleep at Various Study Time Points | Week 9 (n=192,193) | 6.15 units on a scale | Standard Deviation 1.73 |
Secondary
Mean Subject-Reported Number of Naps Each Week at Various Study Time Points.
The mean number of naps per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 3 (n=110,92) | 3.67 number of naps | Standard Deviation 4.67 |
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 0 (n=111,94) | 4.03 number of naps | Standard Deviation 4.41 |
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 6 (n=110,93) | 3.26 number of naps | Standard Deviation 4.25 |
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 9 (n=110,93) | 3.10 number of naps | Standard Deviation 4.57 |
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 12 (n=110,93) | 3.10 number of naps | Standard Deviation 5.05 |
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=110,93) | 3.28 number of naps | Standard Deviation 4.51 |
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 14 (n=110,93) | 3.35 number of naps | Standard Deviation 5.32 |
| Placebo | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 16 (n=110,93) | 3.14 number of naps | Standard Deviation 4.63 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 9 (n=110,93) | 2.57 number of naps | Standard Deviation 2.63 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 16 (n=110,93) | 2.61 number of naps | Standard Deviation 3.15 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=110,93) | 2.66 number of naps | Standard Deviation 2.74 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 0 (n=111,94) | 3.88 number of naps | Standard Deviation 3.55 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 3 (n=110,92) | 2.76 number of naps | Standard Deviation 2.96 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 12 (n=110,93) | 2.71 number of naps | Standard Deviation 3.06 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 6 (n=110,93) | 2.64 number of naps | Standard Deviation 3 |
| Eszopiclone | Mean Subject-Reported Number of Naps Each Week at Various Study Time Points. | Week 14 (n=110,93) | 2.90 number of naps | Standard Deviation 3.12 |
Secondary
Mean Subject-reported Physical Well-Being at Various Study Time Points
Physical well-being was rated by study participants on a scale of 0-10, with higher scores representing better well-being. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 3 (n=190,191) | 5.80 units on a scale | Standard Deviation 1.74 |
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 12 (n=190,192) | 6.11 units on a scale | Standard Deviation 1.52 |
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 6 (n=190,192) | 5.92 units on a scale | Standard Deviation 1.57 |
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=190,192) | 5.97 units on a scale | Standard Deviation 1.51 |
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 9 (n=190,192) | 6.06 units on a scale | Standard Deviation 1.53 |
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 14 (n=190,192) | 6.18 units on a scale | Standard Deviation 1.53 |
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 16 (n=190,192) | 6.09 units on a scale | Standard Deviation 1.61 |
| Placebo | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 0 (n=192,193) | 5.45 units on a scale | Standard Deviation 1.98 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 16 (n=190,192) | 6.43 units on a scale | Standard Deviation 1.56 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 0 (n=192,193) | 5.62 units on a scale | Standard Deviation 2.14 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 3 (n=190,191) | 6.30 units on a scale | Standard Deviation 1.77 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 6 (n=190,192) | 6.46 units on a scale | Standard Deviation 1.65 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 14 (n=190,192) | 6.51 units on a scale | Standard Deviation 1.56 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 9 (n=190,192) | 6.56 units on a scale | Standard Deviation 1.56 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Week 12 (n=190,192) | 6.65 units on a scale | Standard Deviation 1.53 |
| Eszopiclone | Mean Subject-reported Physical Well-Being at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=190,192) | 6.49 units on a scale | Standard Deviation 1.56 |
Secondary
Mean Subject-reported Sleep Latency Reported at Various Study Time Points.
Sleep latency answers the question: How long did it take you to fall asleep last night? Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 0 (n=192,191) | 82.17 minutes | Standard Deviation 74.08 |
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 3 (n=192,192) | 68.80 minutes | Standard Deviation 64.51 |
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 6 (n=192,193) | 62.57 minutes | Standard Deviation 60.06 |
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 9 (n=192,193) | 59.23 minutes | Standard Deviation 52.05 |
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 12 (n=192,193) | 58.69 minutes | Standard Deviation 51.84 |
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=192,193) | 62.32 minutes | Standard Deviation 54.82 |
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 14 (n=192,193) | 57.23 minutes | Standard Deviation 49.94 |
| Placebo | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 16 (n=192,193) | 57.62 minutes | Standard Deviation 51.99 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 16 (n=192,193) | 57.17 minutes | Standard Deviation 45.4 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 0 (n=192,191) | 75.68 minutes | Standard Deviation 56.63 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 12 (n=192,193) | 47.66 minutes | Standard Deviation 39.7 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 3 (n=192,192) | 54.69 minutes | Standard Deviation 46.16 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 14 (n=192,193) | 58.89 minutes | Standard Deviation 45.89 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 6 (n=192,193) | 52.11 minutes | Standard Deviation 48.66 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=192,193) | 51.51 minutes | Standard Deviation 43.87 |
| Eszopiclone | Mean Subject-reported Sleep Latency Reported at Various Study Time Points. | Week 9 (n=192,193) | 51.75 minutes | Standard Deviation 51.79 |
Secondary
Mean Subject-Reported Total Nap Time at Various Study Time Points
The total time (minutes) spent napping per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 0 (n=111,94) | 189.31 minutes | Standard Deviation 262.08 |
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 12 (n=110,93) | 148.75 minutes | Standard Deviation 256.87 |
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 6 (n=110,93) | 150.88 minutes | Standard Deviation 226.9 |
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 3 (n=110,92) | 169.24 minutes | Standard Deviation 253.66 |
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 14 (n=110,93) | 163.61 minutes | Standard Deviation 274.13 |
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 9 (n=110,93) | 150.65 minutes | Standard Deviation 234.11 |
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 16 (n=110,93) | 152.76 minutes | Standard Deviation 246.5 |
| Placebo | Mean Subject-Reported Total Nap Time at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=110,93) | 154.88 minutes | Standard Deviation 237.82 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 16 (n=110,93) | 123.83 minutes | Standard Deviation 173.58 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 0 (n=111,94) | 171.62 minutes | Standard Deviation 237.75 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 3 (n=110,92) | 114.43 minutes | Standard Deviation 151.26 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 6 (n=110,93) | 106.99 minutes | Standard Deviation 133.85 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 9 (n=110,93) | 116.39 minutes | Standard Deviation 156.42 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 12 (n=110,93) | 114.76 minutes | Standard Deviation 149.73 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=110,93) | 112.92 minutes | Standard Deviation 135.34 |
| Eszopiclone | Mean Subject-Reported Total Nap Time at Various Study Time Points | Week 14 (n=110,93) | 128.50 minutes | Standard Deviation 173.51 |
Secondary
Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points
Total time spent napping per week stated as a percentage of total time asleep for subjects who napped during baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week14), non-drug treatment follow-up(week 16), & average for double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment and who napped at baseline are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 0 (n=111,94) | 9.05 percentage of total asleep time | Standard Deviation 13.89 |
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 3 (n=110,92) | 7.35 percentage of total asleep time | Standard Deviation 11.94 |
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 6 (n=110,93) | 6.61 percentage of total asleep time | Standard Deviation 11.73 |
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 9 (n=110,93) | 6.41 percentage of total asleep time | Standard Deviation 11.04 |
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 12 (n=110,93) | 6.37 percentage of total asleep time | Standard Deviation 11.77 |
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=110,93) | 6.68 percentage of total asleep time | Standard Deviation 11.37 |
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 14 (n=110,93) | 6.82 percentage of total asleep time | Standard Deviation 11.17 |
| Placebo | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 16 (n=110,93) | 6.57 percentage of total asleep time | Standard Deviation 11 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 16 (n=110,93) | 4.69 percentage of total asleep time | Standard Deviation 6.27 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 0 (n=111,94) | 7.02 percentage of total asleep time | Standard Deviation 8.34 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 12 (n=110,93) | 4.04 percentage of total asleep time | Standard Deviation 5 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 3 (n=110,92) | 4.33 percentage of total asleep time | Standard Deviation 5.53 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 14 (n=110,93) | 4.93 percentage of total asleep time | Standard Deviation 6.19 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 6 (n=110,93) | 3.91 percentage of total asleep time | Standard Deviation 4.83 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=110,93) | 4.09 percentage of total asleep time | Standard Deviation 4.75 |
| Eszopiclone | Mean Subject-Reported Total Nap Time Per Week Stated as a Percentage of the Total Asleep Time at Various Study Time Points | Week 9 (n=110,93) | 4.13 percentage of total asleep time | Standard Deviation 5.15 |
Secondary
Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points.
The mean total minutes asleep each night at different time points: baseline(week 0), double-blind phase(weeks 3,6,9,12), the single-blind follow-up(week 14),the non-drug treatment follow-up(week 16), and the double-blind average(average of weeks 3,6,9,12 values).
Time frame: Weeks 0, 3, 6, 9, 12, 14, 16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 12 (n=192,193) | 334.69 minutes | Standard Deviation 69.91 |
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 0 (n=192,191) | 294.03 minutes | Standard Deviation 63.3 |
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=192,193) | 326.98 minutes | Standard Deviation 62.88 |
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 6 (n=192,193) | 326.25 minutes | Standard Deviation 65.41 |
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 14 (n=192,193) | 336.55 minutes | Standard Deviation 71.13 |
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 3 (n=192,192) | 314.53 minutes | Standard Deviation 63.52 |
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 16 (n=192,193) | 331.29 minutes | Standard Deviation 72.53 |
| Placebo | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 9 (n=192,193) | 332.47 minutes | Standard Deviation 65.25 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 16 (n=192,193) | 344.20 minutes | Standard Deviation 74.91 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 0 (n=192,191) | 297.86 minutes | Standard Deviation 56.14 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 3 (n=192,192) | 347.37 minutes | Standard Deviation 57.17 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 6 (n=192,193) | 358.72 minutes | Standard Deviation 61.47 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 12 (n=192,193) | 367.75 minutes | Standard Deviation 66.08 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Weeks 3,6,9,12 (double blind average)(n=192,193) | 360.08 minutes | Standard Deviation 59.4 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 14 (n=192,193) | 347.12 minutes | Standard Deviation 72.97 |
| Eszopiclone | Mean Subject-reported Total Sleep Time in Minutes at Various Study Time Points. | Week 9 (n=192,193) | 365.80 minutes | Standard Deviation 64.97 |
Secondary
Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points
Wake time after sleep onset is the time spent awake from sleep onset to final awakening. Mean values are reported at baseline(week 0), double-blind phase(weeks 3,6,9,12), single-blind follow-up(week 14), non-drug treatment follow-up(week 16), and the average for the entire double-blind phase(average of weeks 3,6,9,12 values).
Time frame: Weeks 0,3,6,9,12,14,16
Population: Intention to Treat (ITT) population; Only subjects in the ITT population with at least one post-dose assessment are included. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 0 (n=190,191) | 90.86 minutes | Standard Deviation 51.77 |
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 3 (n=190,192) | 83.17 minutes | Standard Deviation 49.63 |
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 6 (n=192,193) | 77.86 minutes | Standard Deviation 48.82 |
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 9 (n=192,193) | 73.33 minutes | Standard Deviation 49.71 |
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 12 (n=192,193) | 72.02 minutes | Standard Deviation 50.44 |
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192,193) | 76.59 minutes | Standard Deviation 47.52 |
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 14 (n=192,193) | 68.39 minutes | Standard Deviation 51.87 |
| Placebo | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 16 (n=192,193) | 71.27 minutes | Standard Deviation 54.61 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 16 (n=192,193) | 61.84 minutes | Standard Deviation 48.93 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 0 (n=190,191) | 92.66 minutes | Standard Deviation 58.11 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 12 (n=192,193) | 53.45 minutes | Standard Deviation 44.23 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 3 (n=190,192) | 64.33 minutes | Standard Deviation 45.97 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 14 (n=192,193) | 60.71 minutes | Standard Deviation 47.07 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 6 (n=192,193) | 56.49 minutes | Standard Deviation 44.25 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Weeks 3,6,9,12 (double blind average)(n=192,193) | 56.68 minutes | Standard Deviation 42.4 |
| Eszopiclone | Mean Subject-reported Wake Time After Sleep Onset (WASO) at Various Study Time Points | Week 9 (n=192,193) | 52.75 minutes | Standard Deviation 42.51 |
Secondary
Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points
The total time spent napping per week as a percent of the total time asleep for subjects who napped during the baseline period. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).
Time frame: Week 0,1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 0 (n=62,58) | 15.12 percentage of total asleep time | Standard Deviation 15.32 |
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 16.29 percentage of total asleep time | Standard Deviation 17.55 |
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 4 (n=57,58) | 14.35 percentage of total asleep time | Standard Deviation 13.63 |
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 7 (n=58,58) | 14.90 percentage of total asleep time | Standard Deviation 12.97 |
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 12 (n=58,58) | 15.18 percentage of total asleep time | Standard Deviation 13.23 |
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=58,58) | 15.16 percentage of total asleep time | Standard Deviation 12.87 |
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 13 (n=58,58) | 15.66 percentage of total asleep time | Standard Deviation 13.84 |
| Placebo | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 15 (n=58,58) | 15.66 percentage of total asleep time | Standard Deviation 12.42 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 15 (n=58,58) | 14.01 percentage of total asleep time | Standard Deviation 8.85 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 0 (n=62,58) | 14.05 percentage of total asleep time | Standard Deviation 9.41 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 12 (n=58,58) | 11.36 percentage of total asleep time | Standard Deviation 9.14 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 1 (n=57,55) | 13.89 percentage of total asleep time | Standard Deviation 10.19 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 13 (n=58,58) | 11.43 percentage of total asleep time | Standard Deviation 8.28 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 4 (n=57,58) | 11.92 percentage of total asleep time | Standard Deviation 9.24 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=58,58) | 12.30 percentage of total asleep time | Standard Deviation 8.64 |
| Eszopiclone | Mean Total Nap Time Per Week as a Percentage of Total Asleep Time Measured Using Actigraphy at Various Study Time Points | Week 7 (n=58,58) | 12.30 percentage of total asleep time | Standard Deviation 10.35 |
Secondary
Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points.
The total nap time per week for subjects who napped during the baseline period. Mean values are reported at baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15), and the average for the double-blind phase(average of weeks 1,4,7,12 values).
Time frame: Week 0,1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 0 (n=62,58) | 418.49 minutes | Standard Deviation 368.31 |
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 1 (n=57,55) | 399.19 minutes | Standard Deviation 298.18 |
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 4 (n=57,58) | 403.18 minutes | Standard Deviation 328.59 |
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 7 (n=58,58) | 414.68 minutes | Standard Deviation 315.2 |
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 12 (n=58,58) | 430.50 minutes | Standard Deviation 313.11 |
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Weeks 1,4,7,12 (double blind average)(n=58,58) | 412.91 minutes | Standard Deviation 292.66 |
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 13 (n=58,58) | 456.48 minutes | Standard Deviation 352.1 |
| Placebo | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 15 (n=58,58) | 452.93 minutes | Standard Deviation 310.68 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 15 (n=58,58) | 436.03 minutes | Standard Deviation 297.32 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 0 (n=62,58) | 438.02 minutes | Standard Deviation 325.66 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 12 (n=58,58) | 364.34 minutes | Standard Deviation 313.03 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 1 (n=57,55) | 445.84 minutes | Standard Deviation 358.33 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 13 (n=58,58) | 350.52 minutes | Standard Deviation 262.61 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 4 (n=57,58) | 381.15 minutes | Standard Deviation 335.03 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Weeks 1,4,7,12 (double blind average)(n=58,58) | 397.11 minutes | Standard Deviation 305.65 |
| Eszopiclone | Mean Total Nap Time Per Week Measured by Actigraphy at Various Study Time Points. | Week 7 (n=58,58) | 406.16 minutes | Standard Deviation 387.87 |
Secondary
Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points
Total sleep time for subset who wore actigraph wrist monitor which monitors rest and activity cycles, sleep parameters calculated by Central Reader. Mean values reported:baseline(week0), double-blind(weeks1,4,7,12), single-blind follow-up(week13), non-drug follow-up(week15) & average for double-blind(average of weeks1,4,7,12 values).
Time frame: Weeks 0,1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 0 (n=64,61) | 351.06 minutes | Standard Deviation 86.05 |
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 1 (n=64,64) | 354.11 minutes | Standard Deviation 94.76 |
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 4 (n=67,67) | 366.69 minutes | Standard Deviation 78.34 |
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 7 (n=68,67) | 368.58 minutes | Standard Deviation 86.48 |
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 12 (n=68,67) | 368.70 minutes | Standard Deviation 83.39 |
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=68,67) | 365.13 minutes | Standard Deviation 79.31 |
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 13 (n=68,67) | 366.47 minutes | Standard Deviation 81.33 |
| Placebo | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 15 (n=68,67) | 365.73 minutes | Standard Deviation 74.47 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 15 (n=68,67) | 369.23 minutes | Standard Deviation 64.82 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 0 (n=64,61) | 367.95 minutes | Standard Deviation 60.86 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 12 (n=68,67) | 382.04 minutes | Standard Deviation 69.98 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 1 (n=64,64) | 381.52 minutes | Standard Deviation 73.83 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 13 (n=68,67) | 364.87 minutes | Standard Deviation 74.16 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 4 (n=67,67) | 382.39 minutes | Standard Deviation 69.41 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=68,67) | 383.30 minutes | Standard Deviation 63.78 |
| Eszopiclone | Mean Total Sleep Time Measured by Actigraphy at Various Study Time Points | Week 7 (n=68,67) | 386.96 minutes | Standard Deviation 63.89 |
Secondary
Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points
Wake time after sleep onset is time spent awake from sleep onset to final awakening. Mean values reported: baseline(week 0), double-blind phase(weeks 1,4,7,12), single-blind follow-up(week 13), non-drug treatment follow-up(week 15) & average for double-blind phase(average of weeks 1,4,7,12 values).
Time frame: weeks 0,1,4,7,12,13,15
Population: The subset population wore an actigraph wrist monitor device every day between Weeks -1 and 16. A total of 17 weeks of actigraphy data was collected but only 7 weeks (Weeks 0,1,4,7,12,13,15) of actigraphy data was overread by a Central Reader and had sleep parameters calculated. Last Observation Carried Forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 0 (n=64,61) | 60.27 minutes | Standard Deviation 29.51 |
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 1 (n=63,64) | 63.53 minutes | Standard Deviation 31.09 |
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 4 (n=67,67) | 64.16 minutes | Standard Deviation 32.11 |
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 7 (n=68,67) | 65.81 minutes | Standard Deviation 35.11 |
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 12 (n=68,67) | 62.41 minutes | Standard Deviation 30.09 |
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=68,67) | 63.69 minutes | Standard Deviation 29.9 |
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 13 (n=68,67) | 64.09 minutes | Standard Deviation 31.39 |
| Placebo | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 15 (n=68,67) | 67.07 minutes | Standard Deviation 37.4 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 15 (n=68,67) | 62.27 minutes | Standard Deviation 25.77 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 0 (n=64,61) | 63.75 minutes | Standard Deviation 29.11 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 12 (n=68,67) | 60.22 minutes | Standard Deviation 23.1 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 1 (n=63,64) | 55.39 minutes | Standard Deviation 22.11 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 13 (n=68,67) | 63.01 minutes | Standard Deviation 27.84 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 4 (n=67,67) | 58.86 minutes | Standard Deviation 24.51 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Weeks 1,4,7,12 (double blind average)(n=68,67) | 58.21 minutes | Standard Deviation 20.76 |
| Eszopiclone | Mean Values for Wake Time After Sleep Onset Measured Using Actigraphy at Various Study Time Points | Week 7 (n=68,67) | 58.09 minutes | Standard Deviation 22.41 |