Thomas C. Wessel, MD, vice-president of CNS Drug Development, Sepracor Inc., Marlborough, Massachusetts, United States, presented the results of a 6-month, open-label extension study in 471 patients who had completed a 6-month, placebo-controlled study of eszopiclone.

At enrollment, patients ranged from 21 to 64 years of age, had Diagnostic and Statistical Manual -- Revision IV-defined primary insomnia, and self-reported average sleep of less than 6.5 hours per night and/or sleep latency exceeding 30 minutes for at least 1 month before entering the study.

Results show that patients who were previously treated with placebo described immediate and significant improvements in sleep and daytime function (P <.0005 versus baseline for all). Patients who previously received eszopiclone continued to improve (P <.02 for total sleep time for months 7-12). These improvements in sleep and daytime function persisted throughout the entire 6-month extension period.

At the end of the extension, 77% of 111 patients had received eszopiclone for 6 months, and 82% of 360 patients had received it for 12 months.

There were no significant adverse effects upon cessation of eszopiclone, and it was well tolerated for up to 12 months.

Dr. Wessel said that the study is the first placebo-controlled study to assess the safety and efficacy of a sleep agent over a continuous 12-month study period. The agent is the first to be approved for the long-term treatment of insomnia, he said, and its favourable effects are maintained over the long term without the development of tolerance.

According to figures from the National Sleep Foundation, an estimated 100 million adult Americans suffer from insomnia; of these, about 20 million suffer from chronic insomnia. Overall, 20 to 50% of patients surveyed from primary care clinics have insomnia symptoms. In reported population surveys, 20 to 36% had sleep complaints exceeding 1 year in duration. It is estimated that the economic costs related to insomnia total $17.5 billion per year.

The study was supported by Sepracor Inc.


[Presentation title: Twelve Months of Nightly Eszopiclone Treatment in Patients With Chronic Insomnia: Assessment of Long-Term Safety and Efficacy. Abstract P01.059]

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