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Zolpidem Trial for Insomnia Shows Good Results

Three to seven doses a week improves sleep onset, reduces morning sleepiness

MONDAY, Jan. 7 (HealthDay News) -- A 12.5-mg dose of extended-release zolpidem administered between three and seven nights a week for up to six months improves sleep onset and maintenance while reducing morning sleepiness and improving next-day concentration, researchers report in the January edition of Sleep.

Andrew D. Krystal, M.D., of Duke University Medical Center in Durham, N.C., and colleagues conducted a double-blind, placebo-controlled study of 1,018 patients, of whom 669 were randomized to receive 12.5 mg of zolpidem while the remaining 349 were given placebo. In all, 436 patients completed the study period, including 184 patients (52.4 percent) in the placebo arm.

At the 12-week mark, 89.8 percent of the treatment group reported that zolpidem helped them sleep, versus 51.4 percent for those in the placebo group. Measures of morning sleepiness and ability to concentrate showed greater improvements at all time points for the treatment group than the placebo group. Reported side effects of zolpidem included headache, anxiety and somnolence. None of the subjects reported rebound insomnia.

"Non-nightly dosing may offer many advantages over nightly dosing, including decreased drug exposure, increased patient control over therapy and reduced medication expense," the authors write. "These findings extend those from short-term studies, supporting the safety and efficacy of long-term zolpidem, extended-release pharmacotherapy for insomnia," they conclude.

Funding was provided by Sanofi-Aventis.

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