FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Calls for Boxed Warning on Some Prescription Insomnia Drugs

May 7, 2019

The FDA is requiring boxed warnings for certain prescription sedatives following reports of serious injuries and deaths linked to “complex sleep behaviors.”

The agency decided to require boxed warnings for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) after receiving reports of serious injuries and deaths caused by sleepwalking, sleep driving and activities undertaken while not fully awake, such as using a stove.

CDER Director Janet Woodcock said the agency has “closely watched the safety profile of these drugs since they were approved.” The agency’s safety monitoring recently flagged the risk of more serious injuries and deaths, so “we determined there was a need to take stronger steps to inform the public,” she said.

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