Safety of zaleplon in the treatment of insomnia

To evaluate the safety of zaleplon, a quick-acting, rapidly eliminated nonbenzodiazepine (non-BZD) hypnotic, as described in clinical investigations of adult and/or elderly subjects.

Published and presented studies evaluating zaleplon, a novel non-BZD, were identified via MEDLINE (1995-July 2001), Current Contents (ISI database), bibliographic reviews, and consultation with sleep specialists who also identified published abstracts containing data not yet published in peer-reviewed journals.

Transient and chronic insomnia are common problems that should be clinically evaluated and appropriately treated. BZDs have been a primary pharmacotherapy for treating insomnia, despite their disadvantages. Newer hypnotics, characterized by increased receptor-binding specificity and favorable pharmacokinetics, provide potentially better alternatives to BZDs. Assessments included residual sedation, psychomotor impairment, or cognitive dysfunction during treatment, as well as the occurrence of rebound insomnia and withdrawal effects after discontinuation of therapy.

Zolpidem, the first non-BZD hypnotic, appears to have short- and long-term safety profiles similar to those of the BZD triazolam. Zaleplon, a newer non-BZD sleep medication, has a quick onset of action and undergoes rapid elimination, which results in a better safety profile than previously available agents. Additionally, rebound insomnia and other withdrawal effects have not been demonstrated with zaleplon, and the drug is well tolerated in both young and elderly patients. These characteristics may be clinically advantageous for patients who should not receive BZDs.