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Evaluation of eszopiclone discontinuation after cotherapy with fluoxetine for insomnia with coexisting depression.
J Clin Sleep Med. 2007 Feb 15; 3(1):48-55.JC

Abstract

BACKGROUND

Insomnia and major depressive disorder (MDD) may coexist. This study evaluated hypnotic discontinuation effects following an 8-week placebo-controlled study of eszopiclone/fluoxetine cotherapy in patients with insomnia and comorbid MDD.

METHODS

Patients meeting DSM-IV criteria for MDD and insomnia received fluoxetine each morning for 8 weeks and were randomized to concomitant treatment with nightly eszopiclone 3 mg (cotherapy) or placebo (monotherapy). Thereafter, patients received 2 weeks of continued fluoxetine plus single-blind placebo.

RESULTS

Incidence rates of central nervous system (CNS) and potentially CNS-related adverse events (AEs) during the run-out period were similar between treatment groups (8.8% with monotherapy vs 9.8% with cotherapy), and there was no evidence of benzodiazepine withdrawal AEs. Physician-assessed Clinical Global Impression improvements in depressive symptoms were maintained after eszopiclone discontinuation. Improvements in 17-item Hamilton-Depression Rating Scale (HAMD-17) scores with cotherapy versus monotherapy seen at Week 8 (p = .0004) were maintained at Week 10 (p < .0001) and significantly higher depression response and remission rates were observed after cotherapy at Week 10 (p < .02). Patients discontinued from eszopiclone maintained improvements in SL (sleep latency), WASO (wake after sleep onset), and TST (total sleep time) during the 2 weeks following discontinuation (p < .05).

CONCLUSIONS

In this study, eszopiclone discontinuation did not result in significant CNS or benzodiazepine withdrawal AEs, rebound insomnia, or rebound depression; and improvements in sleep and depressive symptoms were maintained.

Authors+Show Affiliations

Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. krystal@phy.duke.eduNo 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

17557453

Citation

Krystal, Andrew, et al. "Evaluation of Eszopiclone Discontinuation After Cotherapy With Fluoxetine for Insomnia With Coexisting Depression." Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine, vol. 3, no. 1, 2007, pp. 48-55.
Krystal A, Fava M, Rubens R, et al. Evaluation of eszopiclone discontinuation after cotherapy with fluoxetine for insomnia with coexisting depression. J Clin Sleep Med. 2007;3(1):48-55.
Krystal, A., Fava, M., Rubens, R., Wessel, T., Caron, J., Wilson, P., Roth, T., & McCall, W. V. (2007). Evaluation of eszopiclone discontinuation after cotherapy with fluoxetine for insomnia with coexisting depression. Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine, 3(1), 48-55.
Krystal A, et al. Evaluation of Eszopiclone Discontinuation After Cotherapy With Fluoxetine for Insomnia With Coexisting Depression. J Clin Sleep Med. 2007 Feb 15;3(1):48-55. PubMed PMID: 17557453.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of eszopiclone discontinuation after cotherapy with fluoxetine for insomnia with coexisting depression. AU - Krystal,Andrew, AU - Fava,Maurizio, AU - Rubens,Robert, AU - Wessel,Thomas, AU - Caron,Judy, AU - Wilson,Phebe, AU - Roth,Thomas, AU - McCall,W Vaughn, PY - 2007/6/15/pubmed PY - 2007/7/25/medline PY - 2007/6/15/entrez SP - 48 EP - 55 JF - Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine JO - J Clin Sleep Med VL - 3 IS - 1 N2 - BACKGROUND: Insomnia and major depressive disorder (MDD) may coexist. This study evaluated hypnotic discontinuation effects following an 8-week placebo-controlled study of eszopiclone/fluoxetine cotherapy in patients with insomnia and comorbid MDD. METHODS: Patients meeting DSM-IV criteria for MDD and insomnia received fluoxetine each morning for 8 weeks and were randomized to concomitant treatment with nightly eszopiclone 3 mg (cotherapy) or placebo (monotherapy). Thereafter, patients received 2 weeks of continued fluoxetine plus single-blind placebo. RESULTS: Incidence rates of central nervous system (CNS) and potentially CNS-related adverse events (AEs) during the run-out period were similar between treatment groups (8.8% with monotherapy vs 9.8% with cotherapy), and there was no evidence of benzodiazepine withdrawal AEs. Physician-assessed Clinical Global Impression improvements in depressive symptoms were maintained after eszopiclone discontinuation. Improvements in 17-item Hamilton-Depression Rating Scale (HAMD-17) scores with cotherapy versus monotherapy seen at Week 8 (p = .0004) were maintained at Week 10 (p < .0001) and significantly higher depression response and remission rates were observed after cotherapy at Week 10 (p < .02). Patients discontinued from eszopiclone maintained improvements in SL (sleep latency), WASO (wake after sleep onset), and TST (total sleep time) during the 2 weeks following discontinuation (p < .05). CONCLUSIONS: In this study, eszopiclone discontinuation did not result in significant CNS or benzodiazepine withdrawal AEs, rebound insomnia, or rebound depression; and improvements in sleep and depressive symptoms were maintained. SN - 1550-9389 UR - https://www.unboundmedicine.com/medline/citation/17557453/Evaluation_of_eszopiclone_discontinuation_after_cotherapy_with_fluoxetine_for_insomnia_with_coexisting_depression_ L2 - http://www.diseaseinfosearch.org/result/2199 DB - PRIME DP - Unbound Medicine ER -