Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Sanofi-Synthelabo
• Treatments: Zolpidem

Criteria

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 cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(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 alcohol abuse or dependence

• inadequate language comprehension

• pregnancy

• first-degree relatives with bipolar disorder or schizophrenia