Safety and Efficacy of Chronic Hypnotic Use 2

Phase 4

Completed

• Conditions: Chronic Insomnia
• Interventions: Drug: Zolpidem CR; Drug: placebo; Drug: Eszopiclone

• Registration Number: NCT02456532
• Lead Sponsor: Henry Ford Health System

Brief 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.

Detailed Description

Persons with DSM-V diagnosed insomnia disorder, aged 18-65 yrs, with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency will be entered to the trial. Following a screening NPSG and MSLT, participants will be randomized to zolpidem XR 12.5 mg (n=60), eszopiclone 3 mg (n=60), or placebo (n=50) nightly for 6 months. After 6 months of nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned "blinded" medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). Nightly sleep at home will be recorded by actigraphy for one week after the screening NPSG and MSLT and before treatment is initiated and actigraphy again during the two week discontinuation.

Study Timeline

• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-28
• Study Start: 2015-08-05
• Primary Completion: 2022-02-22
• Study Completion: 2022-02-22
• Results First Submitted: 2023-06-15
• Status Verified: 2023-07
• Results First Submitted QC: 2024-03-27
• Last Update Submitted: 2024-03-27
• Results First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zolpidem CR	Zolpidem CR	Intervention: Six months of zolpidem cr 12.5 mg nightly use
Placebo	placebo	Intervention: Six months of nightly placebo
Eszopiclone	Eszopiclone	Intervention: Six months of eszopiclone 3 mg nightly use

Primary Outcome Measures

Name	Time	Method
Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period	total number of capsules chosen in week 1 and week 2 of the discontinuation period	instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary

Secondary Outcome Measures

Name	Time	Method
Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period	mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period	comparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period

Trial Locations

Locations (1)

HFHS Sleep Disorders Ctr; 🇺🇸 Detroit, Michigan, United States