Zaleplon, A Novel Nonbenzodiazepine Hypnotic, Effectively Treats Insomnia in Elderly Patients Without Causing Rebound Effects

Sonia Ancoli-Israel, Ph.D.; James K. Walsh, Ph.D.; Richard M. Mangano, Ph.D.; and Masamoto Fujimori, M.D., for the Zaleplon Clinical Study Group

Background: Insomnia is a very common symptom, particularly in the elderly. Thus, all hypnotic medications should be carefully evaluated in the elderly population. Zaleplon, a new nonbenzodiazepine hypnotic with a short elimination half-life (approximately 1 hour), was evaluated in the current study.

Method: This multicenter, randomized, placebo-controlled outpatient study evaluated the efficacy and safety of zaleplon, 5 and 10 mg, in elderly patients with insomnia (as defined by DSM-IV); zolpidem, 5 mg, was the active comparator. Sleep was assessed in 549 elderly patients (>= 65 years old) by using morning questionnaires completed after each of 7 baseline nights during which placebo was given, 14 nights of double-blind treatment, and 7 nights of placebo after discontinuation of active treatment.

Results: Zaleplon, 10 mg, and zolpidem, 5mg, significantly reduced sleep latency during both weeks of the study. Zaleplon, 5 mg, reduced sleep latency only during week 2. Sleep duration was increased with zolpidem, 5 mg, during weeks 1 and 2 and with zaleplon, 10 mg, during week 1. No clinically significant rebound insomnia was observed after discontinuation of treatment with zaleplon, whereas evidence of rebound effects was seen with zolpidem. There was no significant difference between either zaleplon dose and placebo in the frequency of any central nervous system adverse events.

Conclusion: Zaleplon is effective in reducing latency to sleep without evidence of undesired effects in elderly patients with insomnia.

(Primary Care Companion J Clin Psychiatry 1999;1:114-120)

Received July 12, 1999; accepted July 20, 1999. From the Department of Psychiatry, University of California, San Diego and Veterans Affairs, San Diego Healthcare System, San Diego (Dr. Ancoli-Israel); the Sleep Medicine and Research Center, St. Luke's Hospital and Department of Psychiatry, St. Louis University, St. Louis, Mo. (Dr. Walsh); and Wyeth-Ayerst Research, Radnor, Pa. (Drs. Mangano and Fujimori).

A complete list of the members of the Zaleplon Clinical Study Group who contributed to this study appears at the end of this article.

Supported by Wyeth-Ayerst Research, Radnor, Pa.

Reprint requests to: Sonia Ancoli-Israel, Ph.D., Department of Psychiatry 116A, VASDHS, 3350 La Jolla Village Dr., San Diego, CA 92161 (e-mail: sancoliisrael@ucsd.edu).