FDA Recommends Lower Doses in Ambien, Ambien CR, Edluar, and Zolpimist

By on January 11, 2013
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The Food and Drug Administration (FDA) has published a press release with new findings and recommendations for zolpidem products, which are generic sleeping aid drugs marketed under the brand names Ambien, Ambien CR, Edluar, and Zolpimist, and Intermezzo.

The FDA suggests that the bedtime amount be lessened because new information demonstrates that blood levels in a number of patients may still be high the following morning, which may impair tasks that need awareness, especially driving.

For zolpidem products, studies show the danger for next-morning impairment is greatest for patients using the extended-release versions of these drugs (Ambien CR and generics). Women seem to be most susceptible to this threat because they eradicate zolpidem from their bodies more gradually than men.

As a result of the conclusions, the FDA is mandating the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose usages.