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FDA Wants Ambien Doses Decreased for Women Due to Car Accident Risk

Jan 14, 2013

The Food and Drug Administration warns that people are taking entirely too much of the sleep aid Ambien and it is resulting in an increased number of motor vehicle accidents.

Late last week, according to a New York Times report, the agency warned that women should only be taking about half as much Ambien and other sleep aid drugs that contain the Active Ingredient zolpidem. After compiling several years’ worth of complaints from people saying they felt extraordinarily drowsy the morning after they took Ambien.

That information, combined with lab tests that showed women do not absorb zolpidem as quickly as men and pertinent driving statistics, prompted regulators to issue an order to scale back prescriptions for these drugs, especially for women.

If people have too much of the drug in their body when they wake up from their sleep, it is likely to impair their functioning as they start the day. That equates to an increased risk of being injured in an automobile accident.

The Times cites an FDA Center for Drug Evaluation and Research spokesman who said, paraphrasing, “An estimated 10 percent to 15 percent of women will have a level of zolpidem in their blood that could impair driving eight hours after taking the pill, while only about 3 percent of men do.”

The amount of Ambien prescribed in the U.S. has boomed in recent years. Most of the prescriptions written are for drugs containing zolpidem, namely Ambien. Of the 60 million prescriptions written for a sleep aid in 2011, the agency said, two-thirds of the drugs contained zolpidem. The total of 60 million is a steep hike, up 20 percent, from the total written in 2006.

As stated, this warning from the FDA was prompted by years of complaints from patients taking drugs containing zolpidem. The announcement likely comes years after many physicians have already known about the effects of the drug, especially on women. The FDA said it has at least 700 reports compiled from women who associated a driving mishap with a dose of Ambien the previous night. The most incidents were reported in 2007 when the agency ordered a label change on the drug.

Other side effects of the drug include bizarre and sometimes dangerous behaviors performed in the middle of the night while fully under Ambien’s effects. In the morning, many people will have no recollection of doing these things.

Testing of the zolpidem-containing sleep aid Intermezzo and its effect on driving helped link side effects of this and other drugs with impaired driving skills.

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