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FDA Lowers Recommended Dose for Insomnia Drug Zolpidem — Physician’s First Watch

Medical News |
January 11, 2013

FDA Lowers Recommended Dose for Insomnia Drug Zolpidem

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.

Reader Comments (2)

MP Steinberg

Yours and the FDA's commentary on this do not mention the signs and symptoms of the people presenting with this problem. It would be helpful to know that important clinical information.

Competing interests: None declared

Kristin Kelley

According to the SAMHSA report (cited here: http://firstwatch.jwatch.org/cgi/content/full/2013/503/1), adverse reactions included sleepwalking and "sleep driving," behavioral changes (e.g., bizarre behavior and agitation), dizziness, and hallucinations.

Competing interests: Article author

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