[ad_1]
(CBS News) – Millions of Americans suffer from insomniaand many of them depend on sleeping medications to spend the night. Federal health officials have warned of possible side effects for years and have so far issued their strongest warning.
The FDA has ordered that several popular types of prescription sleeping pills, including Ambien, Lunesta and Sonata, are now accompanied by a prominent "black box" warning. Patient labels and guides will warn consumers of the possibility of dangerous side effects.
"They wake up for some reason during to sleep and they demonstrate behaviors that we could adopt upon waking, such as walking, eating, possibly driving, "Dr. Nancy Foldvary-Schaefer of the Cleveland Clinic's Sleep Disorders Center told CBS News.
Black box warnings are the most important warning of the FDA. The FDA has stated that the three medications involved in the warning – zolpidem, eszopiclone and zaleplon – should not be administered to people who have ever had a "complex sleep behavior", such as as sleepwalking.
It is not clear why some people experience more troubling side effects than others.
"Some people may be genetically predisposed to these types of disorders and the drugs may become an additional trigger," said Foldvary-Schaefer.
Doctors say that if the side effects of sleeping pills are rare, they can lead to serious or even fatal injuries.
The FDA has issued the new requirement after a safety review involving 66 cases in which patients have engaged in activities that result in serious injury or death, such as sleepwalking or driving while they are not involved. were not fully awake. According to the FDA, some people have suffered falls, burns, near drowning, car accidents or lost limbs after exposure to extremely cold temperatures. Of these cases, 20 people died.
"These incidents may occur after the first dose of these sleeping pills or after a longer period of treatment, and may occur in patients with no history of these behaviors and even at the lowest recommended doses," said the acting commissioner of the FDA, Ned Sharpless, MD. in a report.
Foldvary-Schaefer says the government's warning is an important reminder that drugs should not be the only tool to fight insomnia.
"Ten to fifteen percent of American adults suffer from a chronic insomnia disorder and have often been treated with these drugs as first-line treatment," said Foldvary-Schaefer. "Other treatments, not drugs but behavioral therapies, work as well, if not better, in the long run."
These therapies include relaxation techniques and a better sleep environment.
[ad_2]
Source link