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

Publication ,  Journal Article
Roth, T; Walsh, JK; Krystal, A; Wessel, T; Roehrs, TA
Published in: Sleep Med
November 2005

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 (P

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Published In

Sleep Med

DOI

ISSN

1389-9457

Publication Date

November 2005

Volume

6

Issue

6

Start / End Page

487 / 495

Location

Netherlands

Related Subject Headings

  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Piperazines
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Hypnotics and Sedatives
  • Humans
  • Follow-Up Studies
  • Female
 

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Roth, T., Walsh, J. K., Krystal, A., Wessel, T., & Roehrs, T. A. (2005). An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med, 6(6), 487–495. https://doi.org/10.1016/j.sleep.2005.06.004
Roth, Thomas, James K. Walsh, Andrew Krystal, Thomas Wessel, and Timothy A. Roehrs. “An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia.Sleep Med 6, no. 6 (November 2005): 487–95. https://doi.org/10.1016/j.sleep.2005.06.004.
Roth T, Walsh JK, Krystal A, Wessel T, Roehrs TA. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med. 2005 Nov;6(6):487–95.
Roth, Thomas, et al. “An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia.Sleep Med, vol. 6, no. 6, Nov. 2005, pp. 487–95. Pubmed, doi:10.1016/j.sleep.2005.06.004.
Roth T, Walsh JK, Krystal A, Wessel T, Roehrs TA. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med. 2005 Nov;6(6):487–495.
Journal cover image

Published In

Sleep Med

DOI

ISSN

1389-9457

Publication Date

November 2005

Volume

6

Issue

6

Start / End Page

487 / 495

Location

Netherlands

Related Subject Headings

  • Treatment Outcome
  • Sleep Initiation and Maintenance Disorders
  • Piperazines
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Hypnotics and Sedatives
  • Humans
  • Follow-Up Studies
  • Female