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Safety and Efficacy of Chronic Hypnotic Use 2 — CIS2  

Chronic Insomnia Clinical Trial

Official title:
Risks for Transition From Therapeutic Hypnotic Use to Abuse

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02456532
Study type Interventional
Source Henry Ford Health System
Contact
Status Completed
Phase Phase 4
Start date August 5, 2015
Completion date February 22, 2022
View Details
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