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Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder.
Biol Psychiatry. 2006 Jun 01; 59(11):1052-60.BP

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.

Authors+Show Affiliations

Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA 02114, USA. mfava@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16581036

Citation

Fava, Maurizio, et al. "Eszopiclone Co-administered With Fluoxetine in Patients With Insomnia Coexisting With Major Depressive Disorder." Biological Psychiatry, vol. 59, no. 11, 2006, pp. 1052-60.
Fava M, McCall WV, Krystal A, et al. Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. Biol Psychiatry. 2006;59(11):1052-60.
Fava, M., McCall, W. V., Krystal, A., Wessel, T., Rubens, R., Caron, J., Amato, D., & Roth, T. (2006). Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. Biological Psychiatry, 59(11), 1052-60.
Fava M, et al. Eszopiclone Co-administered With Fluoxetine in Patients With Insomnia Coexisting With Major Depressive Disorder. Biol Psychiatry. 2006 Jun 1;59(11):1052-60. PubMed PMID: 16581036.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. AU - Fava,Maurizio, AU - McCall,W Vaughn, AU - Krystal,Andrew, AU - Wessel,Thomas, AU - Rubens,Robert, AU - Caron,Judy, AU - Amato,David, AU - Roth,Thomas, Y1 - 2006/04/03/ PY - 2005/08/12/received PY - 2005/12/23/revised PY - 2006/01/26/accepted PY - 2006/4/4/pubmed PY - 2006/9/28/medline PY - 2006/4/4/entrez SP - 1052 EP - 60 JF - Biological psychiatry JO - Biol. Psychiatry VL - 59 IS - 11 N2 - 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. SN - 0006-3223 UR - https://www.unboundmedicine.com/medline/citation/16581036/Eszopiclone_co_administered_with_fluoxetine_in_patients_with_insomnia_coexisting_with_major_depressive_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0006-3223(06)00185-5 DB - PRIME DP - Unbound Medicine ER -