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  1. Drug Safety and Availability

FDA Drug Safety Communication: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR

This update is in follow-up to the FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist) issued on 1/10/2013.

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Safety Announcement

[5-14-2013] The U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. FDA has approved these changes because of the known risk of next-morning impairment with these drugs.

FDA is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR)―either 6.25 mg or 12.5 mg―should not drive or engage in other activities that require complete mental alertness the day after taking the drug because zolpidem levels can remain high enough the next day to impair these activities. This new recommendation has been added to the Warnings and Precautions section of the physician label and to the patient Medication Guide for zolpidem extended-release (Ambien CR).

Also included in the updated label are the dosing recommendations previously stated in FDA’s January 2013 Drug Safety Communication: The recommended initial dose of certain immediate-release zolpidem products (Ambien and Edluar) is 5 mg for women and either 5 mg or 10 mg for men. The recommended initial dose of zolpidem extended-release (Ambien CR) is 6.25 mg for women and either 6.25 or 12.5 mg for men. If the lower doses (5 mg for immediate-release, 6.25 mg for extended-release) are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release. However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness.

Health care professionals and patients can access the latest drug labels below.

Ambien
Ambien CR
Edluar

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