Safety and Efficacy of Chronic Hypnotic Use 2 (CIS2)

Henry Ford Health

Status and phase: Completed; Phase 4

Conditions: Chronic Insomnia

Treatments: Drug: Zolpidem CR; Drug: placebo; Drug: Eszopiclone

Study type: Interventional

Funder types: Other

Identifiers

NCT02456532

#9384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intervention: Six months of nightly placebo

Treatment:

Drug: placebo

Zolpidem CR

Active Comparator group

Description:

Intervention: Six months of zolpidem cr 12.5 mg nightly use

Treatment:

Drug: Zolpidem CR

Eszopiclone

Active Comparator group

Description:

Intervention: Six months of eszopiclone 3 mg nightly use

Treatment:

Drug: Eszopiclone