Primary Insomnia Clinical Trial
Official title:
Abuse Liability Associated With 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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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