Intended for healthcare professionals


FDA issues black box warnings on common insomnia drugs

BMJ 2019; 365 doi: (Published 10 May 2019) Cite this as: BMJ 2019;365:l2165
  1. Owen Dyer
  1. Montreal, Canada

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 …

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