Do you take prescription sleep aids? The FDA urges you to think twice

September 9th, 2019

Are you one to reach for a sleeping aid like Ambien when your sleep woes become too much? It’s not uncommon. Millions of Americans look to prescription sleep aids to get the rest they need, but there’s a dark side to this sleep-in-a-pill approach. So much so, that the FDA has recently mandated stronger warnings about incidents related to popular prescription sleep meds  

Warnings on the box 

As of April 2019, the FDA announced that certain prescription insomnia drugs will now require a warning on the box. This is considered the agency’s strongest warning. The language warns of rare but potentially life-threatening occurrences connected with taking certain sleep aids. These include sleep walking, sleep driving, and even using appliances while not fully alert. Imagine the dangers of operating a hot stove or oven while sleeping! 

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A warning on the box is considered the agency’s strongest warning.

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Why now?  

The FDA keeps a close eye on drugs in the market, reviewing their claims and any new side effects that arise from use. The agency reviewed 66 cases where those taking certain sleep aids were engaging in activities that could be dangerous or even fatal, while not fully awake. Some included accidental falls, near drowning, self-inflicted injuries, and fatal motor vehicle crashes.  

In the FDA’s press release, commissioner Ned Sharpless, M.D. noted the seriousness around this warning. 

“While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk,” said Sharpless. “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.”  

Which drugs are listed? 

The FDA requires these prescription drugs to include a warning on the box: 

  • Ambien 
  • Ambien CR 
  • Edluar 
  • Intermezzo 
  • Zolpimist

What if I’m taking these drugs now? 

SleepScore experts recommend that prescribed sleep medication should only be used for short periods of time, such as 1 or 2 days, and for no longer 2 weeks, and only when really needed, for instance in case of acute insomnia caused by a life eventNote that even for chronic insomnia, the American College of Physicians recommends Cognitive Behavioral Therapy for Insomnia (CBT-I) over hypnotics. 

Finding a pill-free alternative to healthy sleep should always be the first option. This might include behavior or lifestyle changes, finding products that are proven to be effective, or even digital cognitive behavioral therapy (CBTI) if necessary. It can be a hard-fought battle to get the sleep you need but finding safe and proven ways to sleep through the night is always the healthiest option.  

You can read more about the science of sleep and tips for improving your sleep, or check out the SleepScore App to learn about your sleep patterns, get expert advice, and start feeling your best every day.  


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