Trial Outcomes & Findings for Safety and Efficacy of Chronic Hypnotic Use 2 (NCT NCT02456532)
NCT ID: NCT02456532
Last Updated: 2024-03-29
Results Overview
instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
total number of capsules chosen in week 1 and week 2 of the discontinuation period
Results posted on
2024-03-29
Participant Flow
Participant milestones
| Measure |
Placebo
Intervention: Six months of nightly placebo
placebo
|
Zolpidem CR
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Zolpidem CR
|
Eszopiclone
Intervention: Six months of eszopiclone 3 mg nightly use
Eszopiclone
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
16
|
|
Overall Study
COMPLETED
|
14
|
11
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Chronic Hypnotic Use 2
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Intervention: Six months of nightly placebo
placebo
|
Zolpidem CR
n=11 Participants
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Zolpidem CR
|
Eszopiclone
n=16 Participants
Intervention: Six months of eszopiclone 3 mg nightly use
Eszopiclone
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
42.5 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Count of Participants · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Count of Participants · Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Count of Participants · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Count of Participants · Black or African American
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Count of Participants · White
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Count of Participants · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Count of Participants · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Baseline PSG defined sleep efficiency
|
75.2 percent sleep per 8 hrs
STANDARD_DEVIATION 15.9 • n=5 Participants
|
75.7 percent sleep per 8 hrs
STANDARD_DEVIATION 10.5 • n=7 Participants
|
78.7 percent sleep per 8 hrs
STANDARD_DEVIATION 13.0 • n=5 Participants
|
76.7 percent sleep per 8 hrs
STANDARD_DEVIATION 13.3 • n=4 Participants
|
|
Average daytime sleep latency in min
|
11.1 minutes
STANDARD_DEVIATION 5.1 • n=5 Participants
|
11.9 minutes
STANDARD_DEVIATION 6.5 • n=7 Participants
|
11.7 minutes
STANDARD_DEVIATION 5.1 • n=5 Participants
|
11.5 minutes
STANDARD_DEVIATION 5.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: total number of capsules chosen in week 1 and week 2 of the discontinuation periodinstruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary
Outcome measures
| Measure |
Placebo
n=14 Participants
Intervention: Six months of nightly placebo
placebo
|
Zolpidem CR
n=11 Participants
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Zolpidem CR
|
Eszopiclone
n=16 Participants
Intervention: Six months of eszopiclone 3 mg nightly use
Eszopiclone
|
|---|---|---|---|
|
Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period
|
0.43 Total number capsules chosen
Standard Deviation 1.6
|
2.6 Total number capsules chosen
Standard Deviation 4.5
|
6.3 Total number capsules chosen
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: mean nightly sleep efficiency during week 1 and week 2 of the discontinuation periodcomparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period
Outcome measures
| Measure |
Placebo
n=14 Participants
Intervention: Six months of nightly placebo
placebo
|
Zolpidem CR
n=11 Participants
Intervention: Six months of zolpidem cr 12.5 mg nightly use
Zolpidem CR
|
Eszopiclone
n=16 Participants
Intervention: Six months of eszopiclone 3 mg nightly use
Eszopiclone
|
|---|---|---|---|
|
Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period
|
81.9 % sleep time/bedtime
Standard Deviation 8.1
|
84.4 % sleep time/bedtime
Standard Deviation 5.1
|
83.0 % sleep time/bedtime
Standard Deviation 4.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Zolpidem CR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eszopiclone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place