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Hypnotics like Ambien get a new FDA warning of potentially deadly side effects



Image: Tim Boyle (Getty Images)

The Food and Drug Administration is forcing certain sleep medications to become lethal drugs too carry serious warning of the rare, terrifying side effects that they can cause. The side effects that reportedly caused serious injury and even death include sleepwalking and other complicated behaviors that are not fully awakened during sleep, such as driving and cooking.

The New Black Box Warning – The Most Strict Label Used By The FDA is designed to demonstrate potentially life-threatening side effects – applies to three drugs commonly used to combat sleep disorders and marketed under different brand names. They are Eszopiclon (Lunesta), Zaleplon (Sonata) and Zolpidem (Ambien et al.). In addition to the warning, people are also told to stop or avoid taking these medications if they have ever experienced these symptoms.

"We know that millions of Americans suffer from insomnia and need these medications to sleep better at night. Although rare, these events are serious and it is important that patients and health professionals are aware of the risk, "said Ned Sharpless, the current acting director of the FDA, in a statement.

The FDA's decision The agency said it was motivated by its recent review of 66 case reports of strange behaviors associated with these drugs, including some that were directly reported to the FDA, with more than 40 non-fatal but severe reports Injuries associated with these drugs have involved people who have almost drowned, shot themselves, and nearly froze or lost a frozen body.There were twenty reports of deaths from drowning, carbon monoxide poisoning, fatal car accidents, and possibly suicide Reports of cases where people were killed while under the influence of these drugs (especially Ambien).

What has created the connection between these strange behaviors and the use of sleeping pills is all the more puzzling, as it does not seem to have a clear pattern of who is most at risk.

"These events may occur after the first dose of these sleep medications or after a prolonged course of treatment, and may occur in patients without a history of these behaviors and even in patients, the lowest recommended doses," Sharpless noted.

This is just the latest step by the FDA to monitor the use of these drugs more closely, just as the drug companies have tried to reassure public safety. In 2007, she added a similar but less prominent warning to these drugs. In 2013, drug manufacturers had to lower the recommended dose for women and make the same recommendation for men. According to Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, further action could be taken.

"We will continue to monitor and evaluate these risks associated with insomnia medicines and communicate with the public, or consider further action as appropriate," Woodcock said in an FDA statement.


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