FDA Requires Stronger Warnings for Common Insomnia Medications

On Tuesday, the Food and Drug Administration (FDA) announced that several prescription sleep aids must now include aboxed warning—the FDA’s strongest safety warning—following reports of sleepwalking and other rare sleep behaviors that have led to serious injuries and deaths.Sleep aids containing eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) must carry the boxed warning as well as another warning against the use of the medications by patients with a history of sleepwalking or other rare sleep behaviors like sleep driving.This is not the first time that the FDA has issued a safety alert regarding these medications. In 2013 and 2014, the FDA warned of next-morning impairment associated with zolpidem and eszopiclone."We have closely watched the safety profile of these drugs since they were approved," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "When our ongoing safety monitoring recently reflected the risk of more serious injuries and deaths from patients on these medications who experienced complex sleep behaviors, we determined there was a need to take stronger steps to inform the public."The FDA reviewed 66 reports of serious injuries and deaths that occurred while patients were sleepwalking, sleep driving, or engaging in other activities (such as using a stove) while not fully awake, and most had no memory of the incident. The 46 ...
Source: Psychiatr News - Category: Psychiatry Tags: Ambien Ambien CR and Zolpimist boxed warning Edluar eszopiclone FDA insomnia Intermezzo lunesta sleepwalking Sonata zaleplon zolpidem Source Type: research

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Source: Theranostics - Category: Molecular Biology Authors: Tags: Research Paper Source Type: research
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Source: Theranostics - Category: Molecular Biology Authors: Tags: Research Paper Source Type: research
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