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...
Date First Received: September 7, 2005
Last Updated: April 21, 2008
Verified by: University of Rochester, February 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2005
Overall Status: Completed
Estimated Enrollment: 44
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: February 2008
Intervention(s) in this Clinical Trial
- Drug: zolpidem
Outcome Measures for this Clinical Trial
Primary Measures
- Bi-weekly measures during 12 week follow-up for sleep diary measures of sleep latency, wake after sleep onset time, and total sleep time.
- Bi-weekly measures during baseline and treatment for sleep diary measures of sleep latency, wake after sleep onset time, and total sleep time.
Secondary Measures
- weekly insomnia ratings
- weekly sleepiness/fatigue ratings
- weekly mood ratings
- weekly medical symptoms checklist
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: University of Rochester
Overall Clinical Trial Officials and Contacts
Michael L Perlis, Ph.D. Principal Investigator University of Rochester
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
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
Clinical Trials Authorship and Review
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