Safety and Efficacy of Chronic Hypnotic Use
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|ClinicalTrials.gov Identifier: NCT01006525|
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : November 7, 2011
|Condition or disease||Intervention/treatment|
|Primary Insomnia||Drug: zolpidem|
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.
|Study Type :||Observational|
|Actual Enrollment :||116 participants|
|Official Title:||Abuse Liability Associated With Chronic Hypnotic Use|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Primary insomniacs, ages 21-70, in good general health.
placebo or zolpidem (10mg)daily for one year
Other Name: zolpidem (Ambien)
- Sleep recording measures [ Time Frame: one year ]
- Urine and saliva cortical levels [ Time Frame: one year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|