New FDA Warning on Prescription Sleep Aids
Late last month, the US Food and Drug Administration strengthened its warning label requirements on several brands of prescription sleep aids for side effects involving “rare but serious” cases of complex sleep behaviors.
Complex sleep behaviors occur when someone who has taken a prescription sleep aid experiences sleepwalking or engages in some other activity like cooking, eating, or driving a car while in a sleep-like state. The subject usually has little or no memory of what they were doing once they wake up. The FDA has identified a handful of incidents in which these behaviors resulted in accidents causing serious injury or death.
The new warning, announced April 30, 2019, is required on Lunesta (eszopiclone), Sonata (zaleplon), and Ambien and Ambien CR (zolpidem, also sold under the brand names Intermezzo, Zolpimist, and Edluar).
Regulators have also added a contraindication – a warning not to take these drugs if you have experienced a complex sleep behavior from them in the past.
The new labeling requirement specifies a so-called boxed warning (large text with a black border around it) which is the agency’s most prominent warning. Previously, the FDA required a less prominent warning about the side effect in the drug’s labeling. The agency has had its eye on this problem for several years but a recent review of these incidents prompted the change.
The FDA looked at 66 cases of complex sleep behaviors that were associated with the drugs, over the 26 years since they were first approved. The cases resulted in falls, car accidents, accidental overdoses, carbon monoxide poisonings, drownings or near-drownings, burns, hypothermia, self-inflicted gunshot wounds, and apparent suicides or attempted suicides. Of the 66 cases, 20 resulted in fatalities.
Exactly what causes these behaviors and how they are related to the drugs in question is not yet known. In some cases, the behaviors happened after a long course of treatment but could also occur after the first dose. Incidents were reported in patients who had never previously experienced complex sleep behaviors. And they could happen at the lowest recommended dose.
“We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night,” said FDA Acting Commissioner Ned Sharpless, M.D. “While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk”
The FDA strongly encourages anyone taking one of these sleep aids to read through the patient medication guide that comes with their prescription and to review it with each refill in case the information is updated.
Most important: If you take one of the sleep aids listed above and experience any of the side effects described, stop taking the drug immediately and notify your doctor.
My Two Cents
I just want to finish up by adding a few comments of my own – and you should keep in mind as you read this that I’m not a doctor or scientist, so consider it a layman’s opinion.
I think the FDA made the right call. This is definitely something doctors and patients need to be mindful of. But this issue needs to be put in proper perspective. Especially since some news outlets couldn’t report the new label requirements without veering into alarmism.
Prescription sleep aids like Ambien and Lunesta aren’t always the best way to treat sleeplessness and they should never be used indiscriminately. But they are often essential in helping someone get through a bad case of insomnia. The FDA still deems these drugs to be safe as long as the proper guidelines are followed. The accidents described in the 66 cases are tragic. But they constitute a tiny percentage of the millions and millions of prescriptions dispensed over the last 26 years.
I don’t want to sound like a mouthpiece for the pharmaceutical industry. What I want is for anyone who’s taking these drugs or might take them to be spared undue worry. (People who suffer from insomnia already tend to be worriers as it is.)
The accidents from complex sleep behaviors are, as the FDA put it, serious but rare. The risk of this ought to be balanced against the very real risk of accidents and adverse health effects caused by sleep deprivation from insomnia – which are just as serious and altogether too common.