NEW YORK (Reuters Health) - Ambien CR, the extended-release formulation of 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.
Dr. Andrew D. Krystal from Duke University Medical Center in Durham, North Carolina, and colleagues examined the efficacy and safety of extended-release Ambien CR (12.5 milligrams) versus placebo, taken for 3 to 7 nights per week for 24 weeks, in more than 1000 adults with chronic insomnia who had difficulties both falling asleep and staying asleep.
As early as 4 weeks, patients taking Ambien CR reported significantly greater improvement in their sleep habits compared to patients taking placebo, the investigators report, and this difference persisted throughout the entire study.
At the 12-week point, roughly 90 percent of Ambien CR patients reported that the medication helped them sleep, compared with 51 percent of placebo patients.
Moreover, there was no evidence of so-called "rebound" insomnia when the drug was halted.
"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.
