CompletedPhase 4

Safety and Efficacy of Chronic Hypnotic Use 2

United States41 participantsStarted 2015-08-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Total Number of Capsules Taken During Discontinuation From Either Active Drug vs Placebo Over a Two Week Period

Timeframe: total number of capsules chosen in week 1 and week 2 of the discontinuation period

Trial details

NCT IDNCT02456532

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-22

Results submitted2023-06-15

View on ClinicalTrials.gov More Chronic Insomnia trials