FDA Issues Orders Drugmakers To Decrease Sleeping Pill Dosages

FDA Issues Orders Drugmakers To Decrease Sleeping Pill Dosages

January 11th, 2013 // 1:45 pm @


The FDA is requiring drugmakers that sell sleeping pills that contain the zolpidem active ingredient – a list that includes Ambien – to lower current recommended doses by half. Why? New data show that zolpidem blood levels in some patients may be high enough the morning after usage to impair activities that require alertness.

This, of course, includes driving. In fact, the labeling change is based on findings in driving simulation and laboratory studies. In some individuals, these showed zolpidem blood levels can increase the risk of a car accident the morning after use (here is the data summary). So maybe there will be fewer accidents during morning commmutes, say, a year from now.

And since women eliminate zolpidem from their bodies more slowly than men, the FDA told drugmakers the recommended dose should be lowered for women and labeling should recommend that health care professionals consider a lower dose for men, too. And the FDA says data show the risk for impairment is highest for patients taking extended-release forms.

Specifically, the FDA has informed the various drugmakers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release pills, which would be Ambien, Edluar, and Zolpimist, and from 12.5 mg to 6.25 mg for extended-release products, which is Ambien CR.

“To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient’s insomnia,” Ellis Unger, who heads the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, says in a statement.

This is not the first time that the FDA has ordered labeling changes to sleeping pills, of course. In 2007, for instance, the agency issued a warning after prolonged controversy over side effects such as sleepgiving, which involves getting behind the wheel while still sound asleep and driving away.

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