An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia.

Journal Article (Journal Article)

BACKGROUND AND PURPOSE: A double-blind placebo-controlled study of eszopiclone found significant, sustained improvement in sleep and daytime function. The 6-month open-label extension phase is described herein. PATIENTS AND METHODS: Adults (21-64) with primary insomnia who reported sleep duration <6.5 h/night or sleep latency >30 min/night were included. Patient-reported endpoints included sleep and daytime function. Safety and compliance were assessed at monthly clinic visits. The final double-blind month was used as the baseline for efficacy analyses of the open-label period. RESULTS: Patients who were initially randomized to double-blind placebo and then switched to open-label eszopiclone (n=111) significantly reported the following: (1) decreased sleep latency, wake time after sleep onset, and number of awakenings; (2) increased total sleep time and sleep quality; and (3) improved ratings of daytime ability to function, alertness and sense of physical well-being compared to baseline (P5% of patients. CONCLUSIONS: The significant improvements in sleep and daytime function were evident in those switched from double-blind placebo to 6 months of open-label eszopiclone therapy and were sustained during the 6 months of open-label treatment for those receiving prior double-blind eszopiclone. During 12 months of nightly treatment, eszopiclone 3mg was well tolerated; tolerance was not observed.

Full Text

Duke Authors

Cited Authors

  • Roth, T; Walsh, JK; Krystal, A; Wessel, T; Roehrs, TA

Published Date

  • November 2005

Published In

Volume / Issue

  • 6 / 6

Start / End Page

  • 487 - 495

PubMed ID

  • 16230048

International Standard Serial Number (ISSN)

  • 1389-9457

Digital Object Identifier (DOI)

  • 10.1016/j.sleep.2005.06.004


  • eng

Conference Location

  • Netherlands