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Is gender a drug safety issue in the era of personalized medicine?

from PharmExec

In January 2013, FDA told manufacturers to lower the dose of zolpidem, the insomnia treatment, for women, and suggested a 10 milligrams to 5 milligrams for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 milligrams to 6.25 milligrams for extended-release products (Ambien CR). That was based on evidence the drug is metabolized more slowly in women, which makes the side effect of next-day impairment more likely in women than men. more


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