On January 10, 2013 the U.S. Food and Drug Administration (FDA) notified the public of new information about zolpidem, a widely prescribed insomnia drug. FDA 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 focused on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.
FDA reminded the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.The FDA urges health care professionals to caution all patients (men and women) who use these zolpidem products about the risks of next-morning impairment for activities that require complete mental alertness, including driving. For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men.
The FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.
Personnel Injury Attorneys
have been very concerned about the spike in drowsy driving-related accidents.
The FDA, is now acting to ensure that people who take these meds do not retain
such high quantities of the ingredient in their bloodstream. The company
will require manufacturers of popular medications that contain zolpidem like
Ambien and Ambien CR to reduce the recommended dose.
According to the FDA, these
companies will have to cut down the recommended dose for women, by about
50%. The current dose for immediate release products is 10 mg, and that
will be cut to 5 mg. In the case of extended release drugs, the dose will
be reduced from 12.5 mg to 6.25 mg.
The FDA has not made any
specifications in the case of men, but has said that manufacturers need to make
similar cuts to the dose while establishing recommended doses for males
also. The Food and Drug Administration is also requiring that these
manufacturers make very clear the numerous side effects of using these
medications in their product warning labels.
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