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Zolpidem becomes first drug prescribed differently for women.

In 2013, the U.S. Food and Drug Administration (F.D.A.) notified the public of new information about zolpidem, a widely prescribed medication for insomnia. The agency recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement focuses on zolpidem products approved for use at bedtime. The products are marketed as generic medications and under the brand names Ambien[R], Ambien CR[R], Edluar[R], and Zolpimist[R].

Drowsiness is already listed as a common side effect in the labeling of all insomnia drugs, along with warnings that patients may still feel drowsy the day after they take these products. Patients can experience impairment of mental alertness the morning after use even if they feel fully awake.

The risk of next-morning impairment is highest with the extended-release forms of these drugs (Ambien CR[R] and generic brands). Women-appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men do.

Because the use of lower doses results in lower morning blood levels, the F.D.A. is requiring the manufacturers of these agents to lower the recommended doses. The recommended dose for women should be lowered from 10 mg. to 5 mg. for immediate-release products (Ambien[R], Edluar[R], and Zolpimist[R]) and from 12.5 mg. to 6.25 mg. for extended-release products (Ambien CR[R]). For men, health care professionals should consider prescribing the lower doses--5 mg. for immediate-release products and 6.25 mg. for extended-release products.

The recommended doses of Intermezzo[R], a lower-dose zolpidem product approved for middle-of-the-night awakenings, has not changed. When Intemezzo[R] was appoved in November 2011, the label already recommended a lower dosage for women.

The F.D.A. is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including those available without a prescription. To decrease the potential risk of impairment with all insomnia drugs, the lowest effective dose should be prescribed.

(Source: F.D.A., January 13, 2013.)

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Publication:Nutrition Health Review
Geographic Code:1USA
Date:Jun 22, 2012
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