Ambien (Photo : Wikimedia Commons)
The Food and Drug Administration has issued a new ruling advising doctors to prescribe Ambien in smaller doses. The new rules also affect other sleeping medications containing the drug zolpidem.
"The new recommendation applies to drugs containing the active ingredient zolpidem, by far the most widely used sleep aid," writes Sabrina Tavernise in the New York Times. Zolpidem is used in Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien.
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"An estimated 10 percent to 15 percent of women will have a level of zolpidem in their blood that could impair driving eight hours after taking the pill, while only about 3 percent of men do, said Dr. Robert Temple, an official in the agency's Center for Drug Evaluation and Research."
"Using lower doses means less of the drug will remain in the blood in the morning hours, and will reduce the risk that people who use it will be impaired while driving."
The move to restrict doses of zolpidem comes after years of anecdotal evidence showing people who take it are more prone to odd sleepwalking events, nighttime sleeping and even sexual encounters that they have no memory of.
Clinical studies of the side effects have finally been completed, prompting the change.
"As a result, the FDA is ordering companies to cut the dose for women from 10 milligrams to 5 milligrams for immediate-release products - which include Ambien, Edluar and Zolpimist - and from 12.5 milligrams to 6.25 milligrams for the extended-release product Ambien CR," said Rob Stein on NPR News.
"In addition, the FDA ordered companies to change the labeling on the drug for men, recommending doctors consider prescribing the same lower doses for them."
Patients who take any drug containing zolpidem are encouraged to talk to their doctor about any extended sleepiness they experience.
While the new guidelines don't cover sleeping pills with other active ingredients, like Lunesta and Sonata, the FDA is beginning reviews of those drugs as well.