Safety and Efficacy of Chronic Hypnotic Use
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Abuse Liability Associated With Chronic Hypnotic Use|
- Sleep recording measures [ Time Frame: one year ] [ Designated as safety issue: No ]
- Urine and saliva cortical levels [ Time Frame: one year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
urine and saliva
|Study Start Date:||December 2005|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Primary insomniacs, ages 21-70, in good general health.
placebo or zolpidem (10mg)daily for one year
Other Name: zolpidem (Ambien)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006525
|United States, Michigan|
|Henry Ford Sleep and Research Center|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Timothy A. Roehrs, Ph.D.||Henry Ford Health System|
|Study Director:||Surilla Randall, Ph.D.||Henry Ford Health System|