Makers of sleeping pill ordered to lower dose for women: FDA

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Women who take zolpidem - a very popular sleeping pill – process the drug much more slowly than men, and tend to have more traffic accidents related to the pill.

With this new finding about the drug's effect, the US Food and Drug Agency (FDA) has just ordered that zolpidem makers lower the dose for women. Doses for women will be lowered from 10 milligrams to 5 milligrams for regular products, and 12.5 milligrams to 6.25 milligrams for extended-release formulations.

Zolpidem is sold as generics and under the brand-names Ambien, Ambien CR, Edluar, Zolpimist, and Intermezzo.

The FDA recommends that manufacturers lower the dose for men as well, due to reports of driving-related problems related to the drug’s use.

The FDA did not learn why women metabolize zolpidem much more slowly than men.

Read the MeDWatch alert, including links to the Drug Safety Communication, News Release, and Q&As.