Safety and Efficacy of Chronic Hypnotic Use 2

Henry Ford Health System41 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Insomnia

Interventions

placeboDRUG

six months of nightly placebo

Zolpidem CRDRUG

six months of nightly zolpidem

EszopicloneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

HFHS Sleep Disorders Ctr

Detroit, Michigan, United States

Outcomes

Primary Outcomes

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

instruction to stop nightly hypnotic use over a two-week discontinuation period with option to choose of 1, 2, 3 capsules, if necessary

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

Secondary Outcomes

Percent of Time Asleep Over Time in Bed During the Two-week Discontinuation Period

comparing the three treatment arms for nightly hypnotic efficacy using actigraphic determined sleep efficiency over the two week discontinuation period

Time frame: mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period

Data from ClinicalTrials.gov

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