Many Americans with insomnia rely on sleep medications to help them fall asleep and stay asleep.
But recent cases involving people being seriously injured or dying while on these drugs have raised additional concerns about the medications’ safety.
This week the Food and Drug Administration (FDA)
This is the agency’s most prominent warning for medications. It’s now required for three drugs: eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist).
“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 healthcare professionals are aware of the risk,”
The FDA issued the new requirement after conducting a safety review of 66 cases in which people died or were seriously injured while taking one of these medications.
These incidents resulted from people engaging in activities such as sleepwalking or driving while not fully awake.
Nonfatal injuries included falls, burns, loss of a limb, and other injuries due to exposure to extreme cold as well as self-inflicted gunshot wounds.
Twenty people died from carbon monoxide poisoning, hypothermia, motor vehicle collisions, or other causes.
It’s not clear why some people experienced serious side effects from the sleep medication.
“These incidents can occur after the first dose of these sleep medications 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,” said Sharpless.
In addition to the black box warning, the FDA is requiring labels on the medication packages to state that people who have experienced an episode of complex sleep behaviors after taking one of these medications should no longer use them.
The agency will continue to monitor the safety of these medications.
Healthcare professionals and patients can report side effects from these or other medications to the
Insomnia is a common sleep disorder that makes it difficult to fall asleep or stay asleep. It can also cause you to wake up too early and not be able to get back to sleep.
Recent estimates have found that between 30 and 50 percent of U.S. adults have had occasional short-term insomnia, while 5 to 10 percent have chronic insomnia.
About 4 percent of adults in the United States used a prescription sleep medication in the past month, according to the
This includes ones that are required to carry the new FDA warning — also known as “Z-drugs.”
Dr. Cathy Goldstein, a sleep neurologist at the University of Michigan Sleep Disorders Centers, says people considering or already using a Z-drug should be aware of the health risks, including the potential for abnormal sleep-related behaviors, or parasomnias.
“Although not common, the consequences can be profound if the parasomnia is associated with violent, injurious, or sexual behavior,” Goldstein told Healthline.
She recommends that people taking one of the drugs affected by the FDA announcement talk to their doctors about the risks of the medications and other options.
For those who are thinking about taking a prescription sleep medication, there are nondrug treatments that are effective, even for chronic insomnia.
“The preferred treatment for insomnia in most cases is cognitive behavioral therapy for insomnia (CBT-I). Therefore, this should always be considered,” said Goldstein.
This structured nondrug treatment helps people replace thoughts and behaviors that cause sleep problems with habits that promote healthy sleep.
Sleep medications can work over the short term, but CBT-I is a long-term solution. Some people with insomnia, though, may do best with a combination of the two.
Goldstein says if people do need a prescription sleep medication, there are ones not affected by the new FDA warning, such as doxepin (Silenor), ramelteon (Rozerem), and suvorexant (Belsomra).
The American Academy of Sleep Medicine also has a directory of certified sleep centers that specialize in treating insomnia and other sleep disorders, including with CBT.