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FDA cuts sleeping pill dosages to lower car accident risk

If you have ever taken a prescription sleep aid, you are probably well aware of the lingering effects it can have on you. Namely, the drowsiness, distraction and listlessness than can last well into the morning after you take the pill. Often, this is the product of an incorrect dosage or the wrong medication altogether. But regardless of the reason, those lasting effects can have dangerous consequences, significantly raising the risk of car accidents and related harms.

In an effort to reduce the risk of auto accidents and other negative effects, the U.S. Food and Drug Administration recently released a new requirement that essentially forces drug manufacturers to cut their maximum dosages of one of the most popular sleep aids in the country. However, the dosage reduction will only apply to women, after recent studies found that they metabolize the drug much more slowly than their male counterparts.

The drug in question is zolpiderm, which is found in popular sleep aids such as Ambien, Intermezzo, Zolpomist and Edluar, as well as generic forms of those medications. Currently, the maximum dosage for zolpiderm is 10 milligrams for women, or 12.5 milligrams for extended-release formulas. Under the new regulation, those amounts will be cut to 5 and 6.25 milligrams, respectively.

The regulation was spurred by a series of driving simulations which found that the levels of zolpiderm in the systems of study participants remained high enough to interfere with driving ability as many as eight hours after taking the drug. When the dosages were cut in half, the number of participants with significant amounts of the drug in their systems decreased significantly.

It is likely that much more research will be conducted on this topic in the coming months and years, especially since the FDA is also requiring drug manufacturers to conduct their own driving simulations in the future.

Source: Associated Press, "FDA requires lower doses for sleep medications," Matthew Perrone, Jan. 10, 2013

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