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Zaleplon shortens subjective sleep latency and improves subjective sleep quality in elderly patients with insomnia. The Zaleplon Clinical Investigator Study Group.

Abstract
Insomnia is a frequent complaint in the elderly population. Hypnotic agents, including benzodiazepines, with longer pharmacological half-lives have been associated with side effects, including residual sedation, memory impairment, and discontinuation effects. Zaleplon is a short-acting (elimination half-life of 1 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 (> or =65 years) outpatients 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 10-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.
AuthorsJ Hedner, R Yaeche, G Emilien, I Farr, E Salinas
JournalInternational journal of geriatric psychiatry (Int J Geriatr Psychiatry) Vol. 15 Issue 8 Pg. 704-12 (Aug 2000) ISSN: 0885-6230 [Print] ENGLAND
PMID10960882 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright 2000 John Wiley & Sons, Ltd.
Chemical References
  • Acetamides
  • Hypnotics and Sedatives
  • Pyrimidines
  • zaleplon
Topics
  • Acetamides (administration & dosage, adverse effects, therapeutic use)
  • Aged
  • Aged, 80 and over
  • Analysis of Variance
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Hypnotics and Sedatives (administration & dosage, adverse effects, therapeutic use)
  • Male
  • Pyrimidines (administration & dosage, adverse effects, therapeutic use)
  • Sleep (drug effects)
  • Sleep Initiation and Maintenance Disorders (drug therapy)
  • Treatment Outcome

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