NCT02456532

Safety and Efficacy of Chronic Hypnotic Use 2

Risks for Transition From Therapeutic Hypnotic Use to Abuse

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	placebo	six months of nightly placebo
DRUG	Zolpidem CR	six months of nightly zolpidem
DRUG	Eszopiclone

Timeline

• Start date: 2015-08-05
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2015-05-28
• Last updated: 2024-03-29
• Results posted: 2024-03-29

Locations

1 site across 1 country: United States