Eszopiclone (trade name Estorra), was administered nightly to patients with chronic insomnia and led to significant improvement in patients' ability to fall asleep and stay asleep and in the quality of their sleep without any evidence of a loss of effect over time, the researchers said. Prior to this study, the longest large-scale, placebo-controlled study of a sleep medication for insomnia lasted five weeks.

The data further demonstrate that improvements in sleep were associated with consistent improvements in the patients' ratings of their capacity to function well during the day, said the researchers. Impairments in daytime function are one aspect of chronic insomnia, and the new study represents the first time any sleep medication has been shown to consistently improve all of the components that define insomnia, they said.

Insomnia is the perception of inadequate or poor-quality sleep that is accompanied by significant distress or impaired function. It is considered to be chronic if it occurs on most nights and lasts a month or more, according to the National Institute of Health.

"I believe that this study is a milestone for research into insomnia treatments," said Andrew Krystal, M.D., lead study author and associate professor of psychiatry and director of the Sleep Research Laboratory and Insomnia Clinic at Duke. "It greatly extends the period of time that a medication has been definitively shown to help people suffering from insomnia and it establishes that studies of longer-term drug treatment of insomnia are not only feasible but can be safely performed."

The research findings appear in the Nov. 1, 2003, issue of the journal Sleep.

The researchers randomized 788 patients aged 21 to 69 into a six-mont
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Contact: Tracey Koepke
koepk002@mc.duke.edu
919-684-4148
Duke University Medical Center
21-Oct-2003