Paper
FDA issues black box warnings on common insomnia drugs
Published May 10, 2019 · O. Dyer
BMJ
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Abstract
The US Food and Drug Administration (FDA) is giving black box warnings—its strongest—to the common sleep drugs eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist). It said that it had found 66 examples of patients who took one of these nonbenzodiazepine hypnotics for insomnia and suffered serious injury or death from an activity they performed unconsciously. The “complex sleep behaviours” exhibited by patients included turning on ovens, driving cars, and shooting themselves with guns. The FDA has reports of 46 serious injuries from causes as varied as …
The FDA has issued black box warnings for common insomnia drugs eszopiclone, zaleplon, and zolpidem, citing 66 cases of patients who suffered serious injury or death due to unconsciously performing complex sleep behaviors, such as turning on ovens, driving cars, and shooting themselves with
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