EFFICACY AND TOLERABILITY OF 14-DAY ADMINISTRATION OF ZALEPLON 5MG AND 10MG FOR THE TREATMENT OF PRIMARY INSOMNIA

Objective: The efficacy and tolerability of zaleplon 5mg and 10mg, a s elective benzodiazepine subtype A receptor agonist, was evaluated duri ng 14-day administration in a double-blind, placebo-controlled design, with triazolam included as an active comparator. Patients and Methods : Polysomnographic data, subjective reports, performance measures, and clinical assessments were made for 132 primary insomniacs, aged 18 to 60 years, during three baseline, 14 drug, and two discontinuation nig hts.Results: Polysomnographic data indicated that both doses of zalepl on shortened latency to persistent sleep relative to placebo, during e arly drug administration. By the end of the administration period the difference was no longer statistically significant, principally due to improvement in the placebo group. No effect on total sleep time or me asures of awakenings was seen with either zaleplon dose. Triazolam inc reased total sleep time and reduced latency to persistent sleep compar ed with placebo on early drug nights, but not at the end of the 2-week administration. In general, subjective data were consistent with poly somnography findings. Clinical evaluations indicated that zaleplon was well tolerated and without residual effects or discontinuation effect s. Adverse effects were infrequent, mild and no more common with zalep lon than with placebo.Conclusion: At the doses evaluated, zaleplon app eared to have hypnotic properties consistent with its pharmacokinetic profile, and a low likelihood of undesired effects.