FDA Orders ‘Black-Box’ Warnings for Sleep Aids

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FDA Orders ‘Black-Box’ Warnings for Sleep Aids
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The FDA said it would require some popular sleep aids to contain a black-box warning for potential serious risks

The Food and Drug Administration said it would require some commonly prescribed sleep aids to carry the agency’s toughest boxed warning about serious risks following reports of at least 20 deaths.

The FDA said on Tuesday prescription insomnia pills that contain eszopiclone, zaleplon and zolpidem would have to display a black-box warning about potential risks and a contraindication that they shouldn’t be taken by patients who have experienced complications such as sleepwalking or driving while asleep.

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