FDA Suggests Lower Dosage for Women Taking Sleep Aids

On behalf of Brown & Crouppen, P.C. posted in Motor Vehicle Accident on Saturday, January 12, 2013

Sleep aid medicine has been available for years and doctors have recognized that sometimes the effects of the medication lasts longer than overnight. This week, the Food and Drug Administration (FDA) announced that women should take half the recommended dosage. Tests have confirmed what doctors have long known, that the medicine can leave people drowsy in the morning.

The FDA recommendation applies to drugs containing the active ingredient zolpidem. After years of complaints, the FDA reviewed studies involving trials of the drug Intermezzo, which had been approved in 2011. The agency found that a concentration of zolpidem in patients’ bloodstream greater than 50 nanograms per milliliter increased the risk of car accidents.

The New York Times notes these drugs, sold as Ambien CR, Edluar, Zolpimist, and Intermezzo, have become popular as Americans need more help to sleep well at night. In addition, of course, helped by well-funded marketing campaigns, the use of sleep drugs has increased 20 percent from 2006 to 2011. The Times notes that 60 million prescriptions have been written for these drugs and 40 million were for products containing zolpidem.

The drugs have been known to have aftereffects for some time, and many within the medical community have wondered why the FDA has been so slow to act. The agency reported having received 700 complaints related to the drug.

Women metabolize the drug more slowly and 10 to 15 percent still have enough in their system the next morning to qualify as impaired, increasing the risk of accidents or injuries from activities such as driving.

Source: The New York Times, “Drug Agency Recommends Lower Doses of Sleep Aids for Women,” Sabrina Tavernise, January 10, 2013

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