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Safety and Efficacy of Chronic Hypnotic Use

Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT01006525
Collaborator
(none)
116
Enrollment
1
Location
68
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The acknowledged drugs of choice for the pharmacological treatment of insomnia are the benzodiazepine receptor agonist hypnotics (BzRA). Studies show that at therapeutic doses, used over the short-term, the abuse liability of BzRAs is relatively low and their efficacy outweighs their minimal risks. However, an increasing number of patients use BzRAs nightly for longer periods of time than is currently indicated (i.e. 4 weeks) and, minimal data on the long-term abuse liability and efficacy of these drugs exist.

This project, using both prospective and retrospective methods, will address questions about the long-term abuse liability and efficacy of the BzRAs. The questions being raised are: What are the abuse liability and efficacy of hypnotics currently being used chronically and what is the prospective abuse liability and efficacy of hypnotics used chronically? Zolpidem is the chosen standard for this project as it is the most frequently prescribed BzRA and also arguably the BzRA with the best short-term efficacy and safety profile. The focus of the first question is clinical; it is about the long-term abuse liability and efficacy of BzRAs, specifically zolpidem, as it is currently being prescribed and about the type of patients who receive this drug. The second question addresses the issue of whether a standard BzRA can be prescribed efficaciously and safely for the long-term to patients with primary insomnia.

Study Design

Study Type:
Observational
Actual Enrollment :
116 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Abuse Liability Associated With Chronic Hypnotic Use
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Insomniacs

Primary insomniacs, ages 21-70, in good general health.

Drug: zolpidem
placebo or zolpidem (10mg)daily for one year
Other Names:
  • zolpidem (Ambien)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sleep recording measures [one year]

    Secondary Outcome Measures

    1. Urine and saliva cortical levels [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. age 21-70 yrs

    2. non-pregnant females who agree to standard birth control for 12 months and males

    3. two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep.

    4. meet DSM-IV criteria for primary insomnia

    Exclusion Criteria:

    1. any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem.

    2. chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses.

    3. current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia.

    4. a history of alcohol or substance abuse within the past two years.

    5. a prestudy positive urine drug screen

    6. consuming >14 standard (1oz) alcoholic drinks per week

    7. caffeine consumption >300 mg/day

    8. smoking during the night (11pm-7am).

    9. medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented.

    10. sleep disordered breathing (SDB) defined as >10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henry Ford Sleep and Research Center Detroit Michigan United States 48202

    Sponsors and Collaborators

    • Henry Ford Health System

    Investigators

    • Principal Investigator: Timothy A. Roehrs, Ph.D., Henry Ford Health System
    • Study Director: Surilla Randall, Ph.D., Henry Ford Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01006525
    Other Study ID Numbers:
    • R01DA017355
    First Posted:
    Nov 3, 2009
    Last Update Posted:
    Nov 6, 2011
    Last Verified:
    Nov 1, 2011
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Zolpidem

    Study Results

    No Results Posted as of Nov 6, 2011