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Health Agencies Update
June 25, 2014

Warnings, Lower Dose for Sleep Drug

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Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;311(24):2473. doi:10.1001/jama.2014.7063

In its latest step to mitigate the risks of residual drowsiness associated with sleeping pills, the US Food and Drug Administration (FDA) has required the maker of the hypnotic eszopiclone to reduce the recommended starting dose.

In 2013, the FDA warned physicians that patients taking the sleeping medication zolpidem may remain too impaired to drive even after a full night’s sleep. The risk of impaired driving was greatest among women and those taking extended-release formulations, according to the agency. At that time, the agency required the drug’s makers to lower the recommended starting dose and advised physicians to initially prescribe the lowest dose necessary to induce sleep.

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