FDA Issues Sleeping Pill Warning - Consumer Justice Foundation

FDA Issues Sleeping Pill Warning

Written by Faith Anderson on January 14, 2013
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Women Metabolize Zolpidem More Slowly Than Men

Federal regulators are requiring drug manufacturers to cut the dose of the sleeping pills in half for women, who process the medication more slowly than men. Doses will be lowered from 10 milligrams to 5 milligrams for regular sleeping pills, and from 12.5 milligrams to 6.25 milligrams for extended-release products. The FDA has also recommended that makers of sleeping pills apply these lower doses to men, but is not making the changes a requirement. The adjusted doses apply to all insomnia treatments containing the drug zolpidem, which is known as the most widely used sleeping aid in the United States. Zolpidem is sold in generic forms and under brand names Ambien, Zolpimist and Edluar as well. The FDA requirement does not affect other popular sleeping pills like Lunesta and Sonata, which contain different active ingredients.

Sleeping Pills May Cause Dangerous Drowsiness

“All sleep drugs have the potential to cause [drowsiness], so health professionals should prescribe – and patients should take – the lowest dose that is capable of preventing insomnia,” said Dr. Ellis Unger, a director of the FDA’s Office of Drug Evaluation. Unger also noted that the FDA will establish requirements for developers of sleep medications to conduct driving simulation studies in the future. Over the years, the FDA has received more than 700 reports of driving-related problems associated with zolpidem. This FDA action however, comes on the heels of several high-profile driving accidents that have been blamed on Ambien throughout the past year, including a September accident involving Tom Brokaw and a July accident involving Kerry Kennedy.

Contact an Experienced Attorney for Help

These FDA requirements were issued after recent driving simulation studies indicated that, in some patients, drug levels remained high enough to cause problems with driving. The studies examined a newer form of zolpidem called Intermezzo, and showed that 33% of women and 25% of men taking extended-release zolpidem had enough of the medication in their system to interfere with driving as much as eight hours later. When the dose was cut in half, however, only 15% of women and 5% of men had those same drug levels. Although the FDA was unable to determine why women metabolize zolpidem-containing sleeping pills so much more slowly than men, they did find that the difference cannot be accounted for by typical factors like weight and size. If you have experienced an injury or side effect that you believe to be associated with a sleeping medication, our consumer advocates at the Consumer Justice Foundation can help you contact an attorney with experience litigating product liability cases.

Posted Under: FDA - Food and Drug Administration
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