Certain commonly used sleeping pills will now contain a new boxed warning alerting patients to possible serious or life-threatening behaviors that may result from taking these drugs, the FDA says
Certain commonly used sleeping pills will now contain a new boxed warning alerting patients to possible serious or life-threatening behaviors that may result from taking these drugs, the US Food and Drug Administration announced Tuesday. The move follows several reports of rare but serious injuries and deaths resulting from sleepwalking, sleep-driving and other complex behaviors while sleeping, such as unsafe use of a stove.
Eszopiclone , zaleplon and zolpidem will require the new boxed warnings, which are the most prominent of FDA cautions, the agency said.Mark Zuckerberg says he invented a 'sleep box' to improve his wife's slumber"These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses," Acting Commissioner Dr.
All patients should be notified about possible"morning after" risks, the FDA said at the time.Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said Tuesday that the agency has monitored these drugs since they were approved: eszopiclone was approved in 2004, zaleplon in 1999 and zolpidem in 1992.
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