Many Americans with insomnia depend on sleep medications to simply help them drift off and stay asleep.
But recent cases involving people being seriously injured or dying while on these drugs have raised additional concerns in regards to the medications’safety.
This week the Food and Drug Administration (FDA) announced that several prescription sleep medications are in possession of to carry a “black box” warning alerting consumers of the potential for serious or life-threatening side effects.
Here is the agency’s most prominent warning for medications. It’s now needed for three drugs: eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist).
“We notice that an incredible number of Americans suffer from insomnia and depend on these drugs to simply help them sleep better at night. While these incidents are rare, they are serious and it’s critical that patients and healthcare professionals are alert to the chance,” Dr. Ned Sharpless, the FDA’s acting commissioner, said in a statement. Rare but serious risks
The FDA issued the newest requirement after conducting a security overview of 66 cases in which people died or were seriously injured while taking one of these medications.
These incidents resulted from people participating in activities such as for example sleepwalking or driving whilst not fully awake.
Nonfatal injuries included falls, burns, loss in a limb, and other injuries because of exposure to extreme cold in addition to self-inflicted gunshot wounds.
Twenty people died from carbon monoxide poisoning, hypothermia, motor vehicle collisions, and other causes.
It’s unclear why some people experienced serious negative 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 cheapest recommended doses,” said Sharpless.
In addition to the black box warning, the FDA is requiring labels on the medication packages to convey that people who have experienced an episode of complex sleep behaviors after taking one of these medications should no more use them.
The agency will continue steadily to monitor the safety of these medications.
Healthcare professionals and patients can report negative effects from these and other medications to the FDA’s MedWatch program. Using medications for sleep
Insomnia is a common sleep disorder that makes it difficult to drift off or stay asleep. It can also cause you to get up too early and not manage to return to sleep.
Recent estimates are finding that between 30 and 50 percent of U.S. adults experienced 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, in accordance with the Centers for Disease Control and Prevention.
Including ones that are required to carry the newest 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 employing a Z-drug should know about the health problems, including the potential for abnormal sleep-related behaviors, or parasomnias.
“But not common, the results may be profound if the parasomnia is related to violent, injurious, or sexual behavior,” Goldstein told Healthline.
She recommends that folks taking one of many drugs afflicted with the FDA announcement talk to their doctors in regards to the risks of the medications and other options. Sleeping better without drugs
For people who are thinking about going for a prescription sleep medication, you will find 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 will always be considered,” said Goldstein.