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By Kristin J. Kelley
Taking the insomnia drug zolpidem (e.g., Ambien) at night could impair alertness the next morning — especially in women — and recommended doses should be lowered, the FDA warned on Thursday.
The warning applies to both generic and brand-name versions of zolpidem and is based on data showing the sedative-hypnotic stays in the body longer than previously thought. The risk for women is higher because they process the drug at a slower rate than men.
Among the agency's recommendations:
For immediate-release products (including Ambien, Edluar, and Zolpimist), the dose for women should be lowered from 10 mg to 5 mg.
For the extended-release product Ambien CR, the dose for women should be lowered from 12.5 mg to 6.25 mg.
For all zolpidem and other insomnia drugs, the lowest dose needed to treat symptoms should be prescribed for both men and women.
Comment
LINK(S):
FDA MedWatch safety alert (Free)
Background: Physician's First Watch coverage of zolpidem and the risk for car accidents (Free)