Long Term Treatment With Zolpidem

Official Title: “Long Term Treatment With Zolpidem: The Relative Efficacy of QHS & Intermittent Dosing and the Potential for Long Term Clinical Gains After Treatment Discontinuation.”

We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.

Intervention(s) in this Clinical Trial

• Drug: Zolpidem
  • 10 mg of Zolpidem

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • QHS dosing with placebo
• Active Comparator: QHS Zolpidem
  • QHS dosing with 10mg of zolpidem
• Experimental: Intermittant Zolpidem
  • Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
• Other: CTRL
  • Monitor only condition.

Primary Measures

• Sleep Latency
  • Time Frame: Pre-Post and Post-Discontinuation
    Safety Issue?: No

Secondary Measures

• WASO
  • Time Frame: Pre-post and post-discontinuation
    Safety Issue?: No

Inclusion Criteria:

• Ages 25 - 55
• a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
• Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic
• Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
• complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months.

Exclusion Criteria:

• Unstable medical or psychiatric illness
• Use of medication that may be "insomnogenic" or may be reduce the effectiveness of zolpidem (e.g. SSRI's, steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
• symptoms suggestive of sleep disorders other than insomnia
• polysomnographic data indicating sleep disorders other than insomnia
• Evidence of active illicit substance use or fitting criteria for ETOH abuse or dependence
• inadequate language comprehension
• pregnancy
• first-degree relatives with bipolar disorder or schizophrenia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 25 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Rochester Other

Overall Clinical Trial Officials and Contacts

Michael L Perlis, Ph.D. Principal Investigator University of Rochester  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00156533

Study ID Number: PI Initiated

ClinicalTrials.gov Identifier: NCT00156533

Health Authority: United States: Institutional Review Board

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