Sleeping Pills Get Black Box Warning

Millions of Americans suffer from sleep disorders or insomnia — and many in that shuteye-deprived cohort rely on sleeping pills to help them fall and stay asleep. Unfortunately, sleeping pills can have many side effects, ranging from constipation and headaches to sleepwalking and daytime drowsiness.

On Tuesday, the FDA took a strong stance against some of the more severe of these side-effect risks by mandating a boxed warning — the most prominent cautionary labeling — be added to the prescribing information and the patient Medication Guides for eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist).

The FDA was compelled to make this update after several reports of rare but serious injuries and deaths occurring from a variety of so-called “complex sleep behaviors,” like sleepwalking, sleep driving or using a stove, following the use of these medicines.

“We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night. While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk. 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,” said FDA Acting Commissioner Ned Sharpless, MD, in a press release. “Today’s action is an important step in our ongoing effort to call more attention to these critical safety issues and serves as an example of our ongoing commitment to ensuring that patients and health care professionals have the information they need to make informed treatment decisions.”

‘Complex Sleep Behaviors’ Can Occur After Only One Dose

The FDA is also requiring a Contraindication, its strongest warning, against continued use in patients who have previously exhibited a “complex sleep behavior” with these prescription sleeping pills. Healthcare providers should cease prescribing eszopiclone, zaleplon and zolpidem to such patients and individuals taking these drugs who have engaged in any of these behaviors should cease their use immediately.

You can read the recent safety announcement in full here and the press release here.

If you or someone you know suffers from such side effects from these medications, you can report serious problems to the FDA through the FDA’s MedWatch program.

Meanwhile, increasing evidence points to the use of psychotherapy, not sleeping pills, as the best remedy for insomnia. In fact, studies have found that cognitive behavioral therapy (CBT), in particular, is the best treatment approach for insomnia. Other natural remedies to bring on slumber include darkening your sleeping environment, limiting your caffeine consumption after noon, not consuming alcohol before bed and switching off electronics.

You’re not curled up in bed reading this on your tablet, right?


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