Phase 4 N=41 Randomized Triple-blind Treatment

Safety and Efficacy of Chronic Hypnotic Use 2

Chronic Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT02456532 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: 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 Total number capsules chosen — p==0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: placebo (Drug); Zolpidem CR (Drug); Eszopiclone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Henry Ford Health System
Primary completion: Feb 2022

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

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.

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

View full record on ClinicalTrials.gov →

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.