Phase 4
Completed N=41
Safety and Efficacy of Chronic Hypnotic Use 2
Source: ClinicalTrials.gov NCT02456532 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period — 0.43; 2.6; 6.3 Total number capsules chosen — p==0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This proposal will assess risks for transition from therapeutic hypnotic use to abuse in people with insomnia. The investigators will study a hypothesized at-risk sub-population, insomniacs with hyperarousal, and compare two hypnotics, a drug with mood effects, eszopiclone, versus one without mood effects, zolpidem.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period |
0.43; 2.6; 6.3 | =0.05 |
| SECONDARY Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period |
81.9; 84.4; 83.0 | =0.643 |
Eligibility Criteria
Inclusion Criteria
- DSM-5 diagnosis of insomnia
Exclusion Criteria
- acute or unstable medical disease,
- current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
Data sourced from ClinicalTrials.gov (NCT02456532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.