CLEVELAND, Ohio — The Cleveland Clinic published a discussion recently concerning the possible side effects of taking prescription sleep medication. The U.S. Food and Drug Administration announced a short time ago that powerful sleep aids must have Black Box warnings on the drugs’ packaging to draw healthcare professionals’ and patients’ attention to the dangerous side effects that taking these drugs might have on someone.
The FDA added the Black Box warning to several insomnia medications because of severe side effects that people have endured while taking the sleep aids. As a result, the FDA now requires Eszopiclone (brand name Lunesta), Zaleplon (brand name Sonata), and Zolpidem (brand names Ambien, Ambien CR, Edluar, Intermezzo, and ZolpiMist) to include the FDA’s Black Box warning on its labels.
The FDA determined that these medicines can cause “complex sleep behaviors” that include sleepwalking, among other potentially life-threatening behaviors. The FDA analyzed numerous reports of people using the stove in their home, trying to drive a car, trying to swim, and other actions which are innocuous generally but can endanger someone’s life if they attempt to perform these tasks while not fully awake. The reports of this behavior led the FDA to conclude that people must be warned about the possible problems associated with insomnia medication.
The FDA said that these side effects are rare, but they can occur at any time and are not limited to a person just starting the therapy. Consequently, patients must learn the side effects of sleep pills so they can watch for behaviors that might place them in danger. Patients might reach a juncture where taking sleep aids are no longer viable because the patient engaged in complex sleep behavior. Experts say that anyone who experiences complex sleep behavior must cease the therapy immediately, even if the event only occurred once.
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