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FDA Requires Lower Recommended Doses For Zolpidem-Containing Sleep Drugs

 January 10, 2013 10:56 AM


(By Balachander) The U.S. Food and Drug Administration (FDA) has recommended lower doses for certain sleep drugs containing zolpidem, a sedative-hypnotic (sleep) medicine that is used in adults to treat insomnia.

The FDA said it is requiring the manufacturers of certain zolpidem-containing products to revise their dosing recommendations because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness.

Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Since women eliminate zolpidem from their bodies more slowly than men, the FDA said it has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men.

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Zolpidem products approved for bedtime use are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

The FDA has informed the manufacturers that the recommended 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 men, the labeling should recommend that health care professionals consider prescribing the lower doses 5 mg for immediate-release products and 6.25 mg for extended-release products.

The FDA said data from clinical trials and driving simulation studies allowed it to better characterize the risk of driving impairment caused by specific blood levels of zolpidem and to recognize the increased risk of driving-impairing blood levels of zolpidem in women.

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This led FDA to require the manufacturers of certain zolpidem-containing products to revise the dosing recommendations, it said.

The U.S. health regulator said it is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.

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