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Federal Health Officials Will Ask Popular Sleeping Drug Manufacturers to Add Warning Labels to Insomnia Prescription Drugs After Investigating Cases of Dangerous, and Sometimes Deadly, Incidents Related to Insomnia Prescription Drugs drugs.
<p class = "canvas-atom-text-canvas Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Warning labels" Black box "& will be required for the original drugs, including Lunesta, Sonata and Ambien, among others, to warn patients of their possible side effects, Food and Drug Administration announced Tuesday. "data-reactid =" 11 ">" Black Box "warning labels will be needed for the original medicines including Lunesta, Sonata and Ambien, among others, to warn patients of their possible side effects, announced Tuesday the Food and Drug Administration.
"Although these incidents are rare, they are serious and it is important for patients and health professionals to be aware of the risk," Acting FDA Commissioner Ned Sharpless said in a statement. "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."
During the review of cases reported to health officials and identified in the medical literature, the FDA found 66 incidents in which injuries or even death had been observed after a patient took eszopiclone insomnia medications, zaleplon or zolpidem, walked or drove while sleeping.
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Of the 66 cases, 20 were fatal. The deaths are due to carbon monoxide poisoning, drowning, falls, hypothermia, car accidents in which the patient drove and presumed suicide, the FDA said.
The 46 non-fatal cases causing serious injury are: accidental overdose, falls, burns, near-drowning, exposure to extremely cold temperatures resulting in the loss of a limb or near death, self-injury such as injury by gunshot and alleged suicide attempts.
In addition to requiring new warning labels on these drugs, the FDA has warned patients with similar incidents not to take these medications.
The FDA has stated that, although warnings about these side effects have already been included on the labels, the new "black box" warning is intended to make them more visible.
<p class = "canvas-atom canvas-text Mb (1.0em) Mb (0) – sm Mt (0.8em) – sm" type = "text" content = "Five hours of sleep are not enough: A study warns about these myths about sleep, harming your health"data-reactid =" 19 ">Five hours of sleep are not enough: A study warns about these myths about sleep, harming your health
Eszopiclone, zaleplon and zolpidem are insomnia medications that help patients fall asleep or stay asleep more easily by slowing down brain activity, the FDA said. The agency had warned of the possible side effects for some the next morning of use.
The FDA estimated that nearly 30 million prescriptions of the three drugs were performed in the United States in 2018.
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