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The Food and Drug Administration has found 66 examples of patients taking drugs and engaging in dangerous activities such as sleepwalking or driving with difficult sleep, 20 deaths related to carbon monoxide poisoning, drowning, fatal falls. , hypothermia and car accidents and apparent suicide.
There have been 46 reports of serious non-fatal injuries, including overdoses, burns, limb loss due to extreme cold, and self-inflicted bullet wounds.
"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 in a statement. Acting FDA Commissioner, NDA Sharpless. "Although these incidents are rare, they are serious and it is important for patients and health professionals to be aware of the risks."
The drugs, which are available as generic, low-cost versions of branded products, will now come with what's known as a boxed warning – the most severe type of warning message from the FDA. In addition to the warning to all patients, the FDA said that people should not take the medication if they had already had episodes of abnormal sleep behavior after taking them.
These cases illustrate how serious, previously unknown, adverse effects may appear on drugs marketed for years and used by millions of people. The FDA monitors side effects through a voluntary reporting system, investigating cases when possible problems arise.
The new warnings apply to Lunesta, which belongs to Sumitomo Dainippon Pharma Co. and is sold under the generic name of Eszopiclone; Pfizer Sonata Inc., also sold as zaleplon; and Ambien and Ambien CR from Sanofi, known as zolpidem. The warning also applies to drugs Edluar, Intermezzo and Zolpimist.
Sumitomo Dainippon, Pfizer and Sanofi did not immediately respond to phone calls and emails requesting comments.
This article was written by Michelle Fay Cortez, a Washington Post reporter.
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