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Key words: Benzodiazepines - Insomnia - Polysomnography - Sleep - Temazepam - Transient insomnia
SUMMARY
Objective: To demonstrate the equivalent efficacy of temazepam 7.5 mg and temazepam 15 mg for the treatment of transient insomnia.
Research design and methods: This was a double-blind, parallel group, multicenter study. Healthy male and female subjects with previous but not current complaints of transient insomnia were enrolled. Transient insomnia was induced in the sleep laboratory by means of the 'first night' effect and by implementing a 2-h phase advance. The effects of both doses of temazepam on polysomnographic (PSG) measures of sleep were evaluated for one night. Latency to persistent sleep (LPS) and total sleep time (TST) were designated as the primary efficacy endpoints.
Results: One hundred and thirty-one subjects completed the study: 65 received the 7.5-mg dose, and 66 received the 15-mg dose. Treatment groups were well matched based on background demographics. No statistically significant differences between doses were detected for LPS, TST, or any other objective (PSG) measure of sleep. Furthermore, both doses were found to be clinically equivalent for LPS and TST based on predetermined criteria. Temazepam was well tolerated, and no significant differences between doses were found for adverse event (AE) incidence, mean score on the Digit Symbol Substitution Task, or mean scores on questions related to tolerability from the Leeds Sleep Evaluation Questionnaire.
Conclusions: The 7.5-mg and 15-mg doses of temazepam were equally effective for the treatment of transient insomnia. In keeping with current practice guidelines, initiation of treatment with temazepam for transient insomnia should begin with the lowest effective dose, i.e., 7.5 mg.
Introduction
Insomnia is a common patient complaint in many physician practices. Its prevalence has been estimated at 13-36% in adult populations1-3 and is known to increase with advancing age1. Although insomnia is not a life-threatening disorder, it negatively impacts upon physical and social function, productivity, and quality of life, and thus effective management is critical4,5. Treatment of insomnia should be individualized according to patient needs and the underlying etiology. According to current consensus, both behavioral and pharmacological approaches have merit; however, for the treatment of repeated episodes of transient insomnia due to factors outside of the patient's control, pharmacotherapy is indicated6.
For the pharmacological management of insomnia, benzodiazepine-receptor...