Some of the most popular sleeping pills on the market are getting new, prominent warning labels after the Food and Drug Administration reviewed dozens of cases that reported dangerous, even fatal consequences of taking the prescription drugs.
The makers of Ambien, Lunesta and Sonata will now be required to feature a prominent "black box" style warning on the box that will warn consumers about the possible side effects, the FDA announced on Tuesday.
The FDA said people taking prescription sleeping pills have complained about exhibiting behaviors they normally do while awake, such as sleep-walking, sleep-eating, and even sleep-driving.
"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," acting FDA commissioner Dr. Ned Sharpless said in a statement. "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."
The three drugs affected by the warning - zolpidem, eszopiclone and zaleplon - should not be given to anyone who has experienced "complex sleep behavior" in the past, the FDA added.
While side effects from sleeping pills are rare, health experts say they can lead to serious or life-threatening consequences. The FDA issued the warning after they conducted a safety review of 66 cases in which patients reported doing things that resulted in a serious injury after taking the medication. Some cases involved falls, burns, near-drownings, car crashes, some even lost limbs after exposure to cold temperatures.
Of the 66 cases the FDA reviewed, 20 people died. The deaths were caused by carbon monoxide poisoning, drowning, falls, hypothermia and an apparent suicide.
"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," Dr. Sharpless said.
All three medications - eszopiclone, zaleplon, and zolpidem are insomnia medications that slow brain activity and help patients fall asleep easier. Nearly 30 million prescriptions for the three drugs were issued in 2018.
"We have closely watched the safety profile of these drugs since they were approved. When our ongoing safety monitoring recently reflected the risk of more serious injuries and deaths from patients on these medications who experienced complex sleep behaviors, we determined there was a need to take stronger steps to inform the public," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "We’ll continue to monitor and evaluate these risks associated with insomnia medications and communicate with the public or consider further actions, as appropriate."
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