Status:
COMPLETED
Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Sanofi-Synthelabo
Conditions:
Insomnia
Primary Insomnia
Eligibility:
All Genders
25-55 years
Phase:
PHASE4
Brief 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...
Detailed Description
To date, the aggressive treatment (Tx) of chronic insomnia has been evaluated in terms of whether maintenance therapy is possible. While what constitutes maintenance therapy is a matter of debate, the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00156533
Start Date
March 1 2005
End Date
February 1 2008
Last Update
November 20 2015
Active Locations (1)
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1
University of Rochester Sleep Research Laboratory
Rochester, New York, United States, 14642