FDA Requires Lower Dosage for Popular Sleep Drugs

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Jan. 10, 2013 -- The FDA is requiring manufacturers of certain popular sleep medications such as Ambien and Zolpimist to cut current recommended doses in half for women. The agency says blood levels of the drugs could still be high enough the following morning to affect activities that require alertness, such as driving.

The agency is also recommending that the labeling of these medications suggest that health care professionals consider a lower dose for men.

Women appear to be more susceptible to a lingering effect because they eliminate the drug’s active ingredient, zolpidem, from their bodies more slowly than men, a statement from the FDA notes.

The action applies to zolpidem products approved for bedtime use, marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. Data show the risk of morning impairment is highest with extended-release forms of these drugs.

"Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose," the FDA statement notes. "FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription."

Specific recommendations are:

  • The dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).
  • For zolpidem and other insomnia drugs, doctors should prescribe the lowest dose that treats the patient's symptoms.
  • Inform patients that impairment from sleep drugs can be present, despite feeling fully awake.

The recommended doses of Intermezzo, a lower-dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dose for women than for men.

The FDA has prepared a list of questions and answers to provide an additional overview of this safety issue.

More information on today's announcement is available on the FDA web site.

Side effects related to the use of zolpidem-containing products may be reported to MedWatch, the FDA's safety information and adverse event reporting program, either online, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or with postage-paid FDA form 3500 to: MedWatch, 5600 Fishers Lane, Rockville, Md., 20852-9787.

Medscape Medical News



News release, FDA.

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