Original articleEszopiclone Co-Administered With Fluoxetine in Patients With Insomnia Coexisting With Major Depressive Disorder
Section snippets
Methods and Materials
This randomized, double-blind, placebo-controlled, parallel-group study was conducted at 67 sites in the United States. The study consisted of subjects with MDD and comorbid insomnia treated daily for 10 weeks with fluoxetine hydrochloride (starting dose 20 mg; dose range: 20–40 mg/day) and randomized to also receive either eszopiclone 3 mg or placebo nightly for 8 weeks, followed by a 2-week single-blind placebo run-out period. All patients gave written informed consent, the institutional
Patient Disposition
A total of 985 patients were screened for study inclusion; 545 of screened patients were randomized and received treatment, and 373 (68.4%) of the randomized patients completed the trial. The three main reasons for screen failures were: 1) patients did not complete three daily diary calls during the baseline period required for randomization, 2) patients had a positive urine drug screen, and 3) patients did not meet the minimum score for the HAM-D-17. The overall discontinuation rates and
Discussion
The present trial is the first large-scale, double-blind, randomized clinical trial of adjunctive use of an FDA-approved insomnia treatment with an SSRI for treatment of insomnia coexisting with a new episode of MDD. In this study, eszopiclone/fluoxetine co-therapy was associated with rapid, substantial, and sustained improvement on the self-reported sleep end points beginning the first night of treatment and continuing throughout the 8-week treatment period. Self-report measures of daytime
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