Safety and Efficacy of Chronic Hypnotic Use 2 (CIS2)

Risks for Transition From Therapeutic Hypnotic Use to Abuse

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.

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Drug: Eszopiclone; Drug: placebo; Drug: Zolpidem CR

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • HFHS Sleep Disorders Ctr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intervention: Six months of nightly placebo	Drug: placebo; six months of nightly placebo
Active Comparator: Zolpidem CR; Intervention: Six months of zolpidem cr 12.5 mg nightly use	Drug: Zolpidem CR; six months of nightly zolpidem; Other Names: Ambian CR
Active Comparator: Eszopiclone; Intervention: Six months of eszopiclone 3 mg nightly use	Drug: Eszopiclone; Other Names: Lunesta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	total number of capsules chosen in week 1 and week 2 of the discontinuation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	mean nightly sleep efficiency during week 1 and week 2 of the discontinuation period

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Timothy A Roehrs, PhD, Henry Ford Health System Sleep Disorders Ctr

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2015
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimated): May 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Eszopiclone; Zolpidem
• Other Study ID Numbers: #9384