FDA strengthens warning about the dangers of sleeping pills

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The Eszopiclone (Lunesta), Zaleplon (Sonata) and Zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist) will require the new boxed warnings, which are the most important warnings from the FDA, said the # 39; agency.

"These incidents may occur after the first dose of these sleeping pills or after a longer period of treatment, and may occur in patients with no history of these behaviors and even at the lowest recommended doses," said the Acting Commissioner. , Dr. Ned Sharpless. declaration.

The agency also said that doctors should not prescribe these drugs to patients who have already suffered such a disease. episodes after taking these medications.

Millions of Americans use sleeping pills, according to a report from US Centers for Disease Control and Prevention: About 4% of adults have been using prescription sleeping pills over the last month. More adult women (5%) use prescription sleeping pills than adult men (3.1%), while white adults (4.7%) are more likely to use pills than blacks ( 2.5%).

All sleep aids do not pose these risks, the FDA noted.

The labels of sleeping pills containing eszopiclone, zaleplon or zolpidem already include a warning, the agency added. Together, the new framed warning and new rule prohibiting prescribing at-risk patients are intended to emphasize existing caveats while suggesting that the risk of injury and death is serious.

The FDA has reported 66 reports of patients in the last 26 years who had taken either eszopiclone, zaleplon or zolpidem and had subsequently sustained serious injury or death while they were not treated. were not fully awake.

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Of the 46 non-fatal injuries, there were accidental overdoses, falls, burns, near-drowning, exposure to extremes of temperature leading to limb loss, self-inflicted bullet wounds, and suicide attempts. . Twenty deaths are due to carbon monoxide poisoning, drowning, falls, hypothermia, road accidents and suicides.

"Patients do not usually remember these events," says an FDA drug safety brief. "The underlying mechanisms by which these insomnia medications cause complex sleep behaviors are not completely understood."

Pfizer, Sonata's drug manufacturer; Sandoz, manufacturer of Ambien; and Sunovion, maker of Lunesta, did not respond to requests for comment.

In 2013, the FDA asked manufacturers of sleeping pills containing the active ingredient zolpidem to reduce the recommended doses. At that time, researchers had found high blood levels of zolpidem in some patients the day after taking doses that affected their cognitive skills, including their ability to drive.

The FDA then stated that lower doses of zolpidem would reduce blood levels the next day. The agency also noted that the recommended doses should be lower for women because they do not treat zolpidem from their system as quickly as men, although doctors may also consider lowering the doses for men . And patients using extended-release forms of these pills run a higher risk of impairment the next morning, according to the agency.

All patients should be informed of possible risks "overnight," said the FDA at the time.

Dr. Janet Woodcock, director of the FDA's Center for Evaluation and Drug Research, said Tuesday that the agency has been monitoring these drugs since their approval: eszopiclone was approved in 2004, zaleplon in 1999 and zolpidem in 1992. "We will continue to monitor and evaluate the risks associated with insomnia medications and communicate with the public or consider new measures as appropriate," she said.

Val Willingham from CNN contributed to this report.

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