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Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder.

Publication ,  Journal Article
Fava, M; McCall, WV; Krystal, A; Wessel, T; Rubens, R; Caron, J; Amato, D; Roth, T
Published in: Biol Psychiatry
June 1, 2006

BACKGROUND: Insomnia and major depressive disorder (MDD) can coexist. This study evaluated the effect of adding eszopiclone to fluoxetine. METHODS: Patients who met DSM-IV criteria for both MDD and insomnia (n = 545) received morning fluoxetine and were randomized to nightly eszopiclone 3 mg (ESZ+FLX) or placebo (PBO+FLX) for 8 weeks. Subjective sleep and daytime function were assessed weekly. Depression was assessed with the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and the Clinical Global Impression Improvement (CGI-I) and Severity items (CGI-S). RESULTS: Patients in the ESZ+FLX group had significantly decreased sleep latency, wake time after sleep onset (WASO), increased total sleep time (TST), sleep quality, and depth of sleep at all double-blind time points (all p < .05). Eszopiclone co-therapy also resulted in: significantly greater changes in HAM-D-17 scores at Week 4 (p = .01) with progressive improvement at Week 8 (p = .002); significantly improved CGI-I and CGI-S scores at all time points beyond Week 1 (p < .05); and significantly more responders (59% vs. 48%; p = .009) and remitters (42% vs. 33%; p = .03) at Week 8. Treatment was well tolerated, with similar adverse event and dropout rates. CONCLUSIONS: In this study, eszopiclone/fluoxetine co-therapy was relatively well tolerated and associated with rapid, substantial, and sustained sleep improvement, a faster onset of antidepressant response on the basis of CGI, and a greater magnitude of the antidepressant effect.

Duke Scholars

Published In

Biol Psychiatry

DOI

ISSN

0006-3223

Publication Date

June 1, 2006

Volume

59

Issue

11

Start / End Page

1052 / 1060

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Sleep Initiation and Maintenance Disorders
  • Sleep
  • Severity of Illness Index
  • Self Disclosure
  • Psychiatry
  • Psychiatric Status Rating Scales
  • Piperazines
  • Middle Aged
 

Citation

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Fava, M., McCall, W. V., Krystal, A., Wessel, T., Rubens, R., Caron, J., … Roth, T. (2006). Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. Biol Psychiatry, 59(11), 1052–1060. https://doi.org/10.1016/j.biopsych.2006.01.016
Journal cover image

Published In

Biol Psychiatry

DOI

ISSN

0006-3223

Publication Date

June 1, 2006

Volume

59

Issue

11

Start / End Page

1052 / 1060

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Sleep Initiation and Maintenance Disorders
  • Sleep
  • Severity of Illness Index
  • Self Disclosure
  • Psychiatry
  • Psychiatric Status Rating Scales
  • Piperazines
  • Middle Aged