Use of sleep aid safe, effective for up to 6 months

NEW YORK (Reuters Health) - The sleeping aid Ambien (also called zolpidem) taken 3 to 7 nights per week is safe and effective for at least 6 months in people who suffer from chronic insomnia, according to research published in the medical journal Sleep.

Insomnia -- the most commonly reported sleep disorder -- is characterized by trouble falling asleep, staying asleep or waking up too early. About 30 percent of adults have symptoms of insomnia.

Many chronic insomnia patients take sedative-hypnotics for up to 5 years, Dr. Andrew D. Krystal from Duke University Medical Center in Durham, North Carolina, and colleagues note in their report, but Ambien and other medications have rarely been studied over extended periods.

They examined the efficacy and safety of Ambien extended-release 12.5 mg versus placebo, taken for 3 to 7 nights per week for 24 weeks, in more than 1000 adults with chronic insomnia who exhibited difficulties both falling asleep and staying asleep.

As early as 4 weeks, patients taking Ambien reported significantly greater improvement in their sleep habits relative to patients taking placebo, the investigators report, and this difference persisted throughout the entire study.

Moreover, there was no evidence of rebound insomnia when the drug was halted. At the 12-week end point, roughly 90 percent of Ambien patients reported that the medication helped them sleep, compared with 51 percent of placebo patients.

"These findings extend those from short-term studies, supporting the safety and efficacy of long-term zolpidem extended-release pharmacotherapy for insomnia," the investigators conclude.

SOURCE: Sleep, January 1, 2008.