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Cited by 480Sleep and related disordersTreatment of Major DepressionObstructive Sleep Apnea Research

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

Fava, Maurizio, McCall, W. Vaughn, Krystal, Andrew, Wessel, Thomas, Rubens, Robert, Caron, Judy, Amato, David, Roth, Thomas·2006·Biological Psychiatry
DOI 10.1016/j.biopsych.2006.01.016
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Abstract

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.

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Crossref · 10.1016/j.biopsych.2006.01.016

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  • Both BzRAs and low-dose sedating ADs have been evaluated as adjunctive agents to other full-dose antidepressants for treatment of comorbid insomnia in patients with depression.

    “Both BzRAs and low-dose se -dating ADs have been evaluated as adjunctive agents to other full-dose antidepressants for treatment of comorbid insomnia in patients with depression. 63,64”

    From Clinical Guideline for the Evaluation and Management of Chronic Insomnia in Adults (2008) · cites this paper as [63]

  • Eszopiclone has a synergistic effect when given in combination with fluoxetine in patients with depression and insomnia.

    “There is clinical evidence for the antidepressant effects of subtype selective GABAAR compounds as eszopiclone, a positive GABAAR modulator with postulated selectivity for α2/α3GABAARs [138], has a synergistic effect when given in combination with fluoxetine in patients with depression and insomnia [139].”

    From An emerging circuit pharmacology of GABAA receptors (2018) · cites this paper as [139]

  • Co-therapy for depression and insomnia leads to better outcomes than monotherapy for depression.

    “Moreover, co-therapy for depression and insomnia leads to better outcomes than monotherapy for depression [20].”

    From The effects of exercise on sleep in unipolar depression: a systematic review and network meta-analysis (2021) · cites this paper as [20]

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Authors
Fava, M., McCall, W. V., Krystal, A., Wessel, T., Rubens, R., Caron, J., Amato, D., & Roth, T.
Affiliations
  • Wake Forest University Health Sciences (US)
  • Duke Medical Center (US)
  • Sunovion (United States) (US)
  • Henry Ford Hospital (US)
ORCID
Venue
Biological Psychiatry
Publisher
Elsevier BV
Published
2006-06
Volume
59
Issue
11
Pages
1052-1060
ISSN
0006-3223 (ISSN-L)
DOI
10.1016/j.biopsych.2006.01.016
OpenAlex
W2000979605
Cited by
480
References
35
Citations by year
2026: 11 · 2025: 14 · 2024: 10 · 2023: 11 · 2022: 8 · 2021: 21 · 2020: 6 · 2019: 16 · 2018: 23 · 2017: 16 · 2016: 26 · 2015: 29 · 2014: 29 · 2013: 37 · 2012: 37
FWCI
46.90
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Biological Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
Keywords
eszopiclone, fluoxetine, insomnia, major depressive disorder, sleep quality, sleep latency, antidepressant response, co-therapy, daytime functioning
MeSH terms
Adult, Depressive Disorder, Double-Blind Method, Drug Therapy, Combination, Female, Fluoxetine, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Middle Aged, Piperazines, Psychiatric Status Rating Scales, Self Disclosure, Severity of Illness Index, Sleep, Time Factors, Treatment Outcome, Antidepressive Agents, Second-Generation, Azabicyclo Compounds

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