Addition Of Lunesta To Lexapro Provides Benefits, Study Finds
This article was originally published in The Pink Sheet Daily
Executive Summary
The sleep aid combined with Lexapro shows a significant improvement in sleep measures compared to Lexapro and placebo.
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Patients with insomnia and generalized anxiety disorder treated with a combination of Sepracor's Lunesta (eszopiclone) and Forest's Lexapro (escitalopram) experienced an improvement in sleep efficacy measures and GAD compared to patients treated with Lexapro alone. Sepracor released the results of a Phase IV, 595-patient trial evaluating Lunesta in patients with insomnia and coexisting GAD Dec. 5 at the American College of Neuropsychopharmacology meeting in Hollywood, Fla. In the 10-week trial, patients who met DSM-IV criteria for both insomnia and GAD were randomized to a regimen of nightly Lexapro 10 mg and Lunesta 3 mg or Lexapro 10 mg and placebo for the first eight weeks, followed by a two-week period in which patients continued on Lexapro and placebo. Patients treated with the Lunesta combination showed a statistically significant improvement in sleep onset, total sleep time, wake time after sleep onset, and number of wakenings, during each double-blind assessment week and when averaged over the eight-week treatment period, Sepracor said. The Lunesta arm also experienced reductions in the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale that were significantly greater than those seen in the placebo-Lexapro arm. According to Sepracor, approximately 10% of adults suffer from chronic insomnia, and 80% of these patients suffer coexisting psychiatric and medical illnesses. Sepracor has been looking to differentiate Lunesta in the crowded sleep market by conducting a number of studies for the treatment of insomnia associated with various conditions (1 (Also see "Lunesta’s Expanded Sales Force Will Focus On Maintenance Use" - Pink Sheet, 25 Apr, 2006.)). Separately, the company published results from a Phase IIIb/IV study evaluating Lunesta for the treatment of insomnia in perimenopausal and menopausal women in the December Journal of Obstetrics and Gynecology. The 410 patients in the study experienced statistically significant improvement on sleep measures compared with placebo. Lunesta's Phase IV program has also examined Lunesta in patients with coexisting depression and pain. The company first presented data on eszopiclone in depression patients in September 2005. Sepracor will likely face an added marketing challenge next year with the patent expiry of Sanofi-Aventis' Ambien (zolpidem) (2 (Also see "Sepracor Sees Sweet Dreams For Lunesta Despite Generic Ambien Next Year" - Pink Sheet, 27 Oct, 2006.)). - Jessica Merrill ([email protected]) |