WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced that commonly used sleeping pills must contain a boxed warning designed to draw attention to concerns that taking these powerful drugs could alter people’s behavior. The FDA published its ruling on Tuesday, April 30, 2019, according to FOX 61 News. The FDA ordered this change on several popular prescription drugs after reports of erratic or dangerous behavior while trying to complete complex tasks. The boxed warning is the FDA’s highest alert level designed to distinguish the information contained in the box from the other relevant information contained on medicinal packaging and marketing materials due to the heightened importance of the warning.
The FDA announced that it would require medications like Lunesta, Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist, and Sonata to include the new boxed warning on the drug packaging and marketing materials. The ruling comes after the FDA learned that people who take the drug began sleep-walking, driving while sleeping, and turning on a stove. These behaviors led to several injuries and deaths.
The FDA noted that reports of dangerous behavior were uncommon. Over the last 26 years, 46 people sustained injuries, and 20 people died after trying to person dangerous tasks while sleeping. However, the FDA determined that the problems happened with sufficient regularity to require an additional warning.
The FDA Acting Commissioner said that people who took the drug for the first time or who had taken a course of the drug for some time engaged in dangerous behavior. A person might develop a pattern of dangerous behavior even if the patient never engaged in that type of behavior previously and was taking the medication at lower doses.
The FDA warned physicians to decline to prescribe the listed medicines to anyone who evidenced similar behaviors in the past. The FDA also said that not all sleep aid drugs do not pose the same problems.
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