Insomnia Is a frequent complaint In the elderly population. Hypnotic agents, including benzodiazepines, with longer pharmacological halt-lives have been associated with side effects, including residual sedation, memory impairment, and discontinuation effects. Zaleplon is a short-acting (elimination hall-life of hour), non-benzodiazepine hypnotic that acts on the benzodiazepine type 1 site of the gamma-aminobutyric acid type A (GABA(A)) receptor complex. The pharmacology and pharmacokinetics of zaleplon suggest a safety profile that is improved over other hypnotics. The objective of this placebo-controlled study was to evaluate the efficacy and safety of zaleplon (5 and 10 mg) in elderly (greater than or equal to 65 years.) out patients with primary Insomnia. This was a multicenter, double blind, randomised, placebo-controlled 2-week outpatient study. Postsleep questionnaires were used to record subjective sleep variables: sleep latency, sleep duration. number of awakenings. and sleep quality. Zaleplon significantly reduced subjective sleep Latency during both weeks of the study with both 5- and 10-mg doses. Subjective sleep quality was improved for significantly more patients treated with zaleplon 10 mg than those treated with placebo during both weeks of treatment. There was a weak indication of rebound insomnia after discontinuation of treatment with the IO-mg dose, but no significant difference In common treatment-emergent adverse events across treatment groups. Zaleplon is an effective and safe hypnotic for the treatment of insomnia in the elderly. Copyright (C) 2000 John Wiley & Sons, Ltd.