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1 Director, Patient Assistance Program, C-Health, P.C., Lebanon, VA
2 Student, School of Pharmacy, Virginia Commonwealth University, Richmond,
VA
3 Associate Professor, Vice Chair for Education, Department of Pharmacy,
Virginia Common-wealth University
Reprints: Dr. Kirkwood, School of Pharmacy, Virginia Common-wealth University, Box 980533, Richmond, VA 23298-0533, fax 804/828-8359, ckkirkwo{at}vcu.edu
OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy data, and adverse effects of eszopiclone in the treatment of transient and chronic insomnia in adult and geriatric patients.
DATA SOURCES: A MEDLINE literature search (1966-May 2005) was conducted to retrieve articles and abstracts involving eszopiclone. The manufacturer of the drug provided a general summary of clinical data and abstracts of unpublished Phase III clinical trials.
STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were reviewed, and information deemed relevant was included for this review.
DATA SYNTHESIS: Food and Drug Administration approval of eszopiclone was based on 6 double-blind, placebo-controlled trials. Five trials published in abstract or study form were reviewed. The sixth trial was not available for evaluation. An open-label continuation trial was also reviewed. All studies showed statistically significant improvements in sleep parameters in adult and elderly patients treated for insomnia with eszopiclone.
CONCLUSIONS: The results of the 5 available double-blind, placebo-controlled studies (and 1 open-label, 6-month extension) showed that eszopiclone was safe and effective in the treatment of transient and chronic insomnia in adult and geriatric patients. Tolerance with long-term exposure (6 mo) and rebound insomnia were not observed. The results of the 6-month, open-label extension trial demonstrated that improvements in sleep parameters were sustained. Future studies comparing eszopiclone with other non benzodiazepine sedative-hypnotics (eg, zolpidem, zaleplon) are needed with cost data to clearly define the role of eszopiclone in the pharmacotherapy of chronic insomnia.
Key Words: eszopiclone, hypnotics, sedative-hypnotics, insomnia
Published Online, August 30, 2005. www.theannals.com, DOI 10.1345/aph.1G179
THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE
UNIVERSAL PROGRAM NUMBER: 407-000-05-027-H01
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