FDA Puts ‘Boxed Warning’ on Ambien, Other Sleep Medications

The FDA has labeled Ambien and other sleep medications with a “black box” warning, which is the strongest listed by the agency.

In a news release on April 30, the agency warned of “sleepwalking, sleep driving, and engaging in other activities while not fully awake,” which have resulted in deaths and injuries.

The behaviors are associated with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.

“As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient medication guides for these medicines,” the agency wrote. Fox News noted that it looks like a “black box.”

“We are also requiring a contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem,” the health agency wrote.

The FDA looked into data spanning 26 years, finding 66 examines of complex sleep behaviors associated with the medications.

Some consumers performed actions that led to lost limbs, extreme cold, and hypothermia. Meanwhile, the FDA said there were instances of drowning, car crashes, carbon-monoxide poisoning, and suicide attempts.

The agency stated that some patients who took the medications don’t remember the incidents that led to their injuries.

FDA Acting Commissioner Dr. Ned Sharpless said that patients who rely on medication for insomnia should be aware of the potential risks.

“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,” Sharpless stated.

He said it’s not clear how the medications trigger complex sleep behaviors that led to harm.

Sharpless said officials noted that millions of Americans have insomnia and rely on such medications “to help them sleep better at night,” adding that “these incidents are rare” but “they are serious and it’s important that patients and health care professionals are aware of the risk.”

He noted that the move on April 30 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.”

Elaborating further, Dr. Nancy Foldvary-Schaefer of the Sleep Disorders Center at Cleveland Clinic said that patients “wake up for some reason during sleep and they exhibit behaviors we would perform while awake, like walking, eating, potentially even driving,” CBS News reported.

She noted that it’s not clear why they experience the symptoms.

“It may be that some people are genetically prone anyway to these kinds of disorders and the medication can become an additional trigger,” Foldvary-Schaefer said.

According to USA Today, the FDA estimated that about 30 million Americans were taking sleep medications in 2018.

RXList says Ambien contains “zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class.”

Recommended dosage “is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg,” says RXList.