FDA Approves Lower-Dose Zolpidem (Ambien) Labels

NBC Nightly News reported that the Food and Drug Administration is recommending patients take a “lower dosage” of zolpidem and warning that the levels of the drug in the bloodstream “can stay high enough to impair concentration and alertness and care should be taken in all activities, including driving.”

According to Reuters, the FDA announced that it has approved labeling changes for anti-insomnia medications containing zolpidem. Noting the drugs can impair patients’ next-day mental alertness, the FDA said it approved labels that reflect lower dosing recommendations for Sanofi SA’s Ambien, Ambien CR and Meda AB’s Edluar. The initial recommended dosages on the new labels are 5 mg for women and 5 mg or 10 mg for men for immediate-release medications containing zolpidem; and 6.25 mg for women and 6.25 or 12.5 mg for men for extended-release zolpidem-based treatments, the FDA said in the announcement. MedPage Today also covers the story.

From the American Association for Justice news release.

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