Insomnia meds get boxed warning from FDA


The Food and Drug Administration will now require that certain medications prescribed for insomnia carry a boxed warning because of associated complex sleep behaviors.

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These behaviors, including sleep walking, sleep driving, and engaging in other activities while not fully awake, are more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than they are with other prescription medicines used for sleep. Although these complex sleep behaviors are rare, they are potentially very dangerous. Boxed warnings are the FDA’s most prominent warning, but the agency will also require a contraindication – its strongest warning – to avoid use in patients who’ve previously experienced these behaviors with any of these medications.

Complex sleep behaviors have been seen with these medications in patients with and without a history of them, at low doses, and even after one dose of the medication. They’ve also been observed with and without concomitant use of alcohol or other CNS depressants.

Health care professionals should advise patients about these risks, even though they are rare. Patients should contact health care professionals if they either experience a complex sleep behavior while not fully awake on one of these medicines or have performed activities they don’t remember while taking the medicine.

More information about these risks and the safety warnings can be found in the FDA’s safety announcement. Other information is also available in a press announcement from the agency.

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