Food and medical supplies are forcing some sleep medications carry the death sura & # 39; oznae warning about rare scary side effects they can cause. Side effects that has been reported to cause suras & # 39; oznyh injury or even death include sleepwalking and other complex behaviors done while the person is asleep or not fully awake, as the management and cooking.
New black-box warning strict FDA label is used to indicate a potentially life-threatening side effects, are applied to the three drugs commonly used for insomnia and are marketed under various trademarks. They Eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, among other names). In addition to prevention, people will also be told to stop or avoid the use of these drugs, if they have ever experienced these symptoms.
"We recognize that millions of Americans suffer from insomnia, and rely on these drugs to help them sleep better at night. Although these cases are rare, they are Suras & # 39; serious, and it is important that patients and health professionals know about the risk, "said Ned Sharpless, the current director, acting in the FDA, in a statement.
FDA decision, the agency said, was motivated by his recent review of 66 case reports about the strange behavior associated these drugs, including those that have been registered with the FDA itself. More than 40 reports of non-fatal, but suras & # 39; oznyh injuries associated with these drugs, the people involved, who nearly drowned, shot and nearly froze to death or lost limbs to frostbite. Twenty reports involved the death from drowning, carbon monoxide poisoning, traffic accidents with fatal outcome car, and probably suicide. There have also been sporadic reports of people killed others while under the influence of these drugs (eg, Ambien).
What made the connection between these strange behaviors and taking a nap helps the more confusing, there does not seem to be a clear picture of who is more at risk of them.
"These cases may occur after the first dose of sleeping medication or after a long period of treatment, and may also occur in patients with no history of such behavior and even at the lowest recommended dosage," Sharpless said.
This is just the latest step in the FDA more carefully monitor the use of these drugs, as even as pharmaceutical companies are trying to convince the public of their safety. In 2007 he added a similar, but less prominent warning of these drugs; in 2013, it required the drug manufacturer to reduce the recommended dose for women and advise the same for men. And more action could come down the pipeline, if necessary, in accordance with Janet Woodcock, director of the FDA Center for Combating Drug Evaluation and Research.
"We will continue to monitor and assess the risks associated with insomnia medications, and communicate with the public and to consider further actions, if needed," said Woodcock, the FDA statement.