Silver Spring, Md., April 30, – The US Food and Drug Administration (FDA) announced today that the agency is seeking a new alert – the agency's most visible threat – for certain prescription drugs for maximum cleaning to better ensure patients and their caregivers the information they need when considering the use of these drugs. The box warning is expressed in a number of reports of rare but serious injuries and deaths resulting from complex sleep behaviors after taking these drugs. These complex sleep behaviors may include walking on the edge of sleep, driving sleep, and engaging in other activities, while not fully awake, such as using the oven safely. The new warnings will be required for eszopiclone (Lunesta), zeppelon (sonata) and zolpidem (Ambien, Ambien CR, Adelvar, Intermezzo, and Zolpimist).
"We recognize that millions of Americans are insomniacs and rely on these drugs to help them sleep better at night, while these cases are rare, serious and important that patients and health professionals are aware of the risk, occurring after the first dose of these sleeping drugs or after a long period of Treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended dose, "said FDA Acting Commissioner Ned Sharpless"Today's action is an important step in our ongoing effort to draw more attention to these critical safety issues and serves as an example of our ongoing commitment to ensuring that patients and healthcare professionals have the information they need to make informed treatment decisions."
In addition to the packaged warning, the agency requires the addition of a label against not using these drugs in patients who have experienced an episode of complex sleep behaviors after taking them. The relationship between these drugs and complex sleep behaviors has been included in the label, which has been updated constantly to indicate additional safety issues as identified. The warning and objections are intended to make the warning more prominent and reflect the risk of serious injury and death.
In the drug safety media released today, the FDA provides recommendations for health professionals and patients, as well as a summary of the data that led to these warnings.
"We have been closely monitoring the safety profile of these drugs since our approval, and our ongoing safety monitoring recently reflects the risk of more serious injuries and deaths from patients on these drugs who have experienced complex sleep behaviors. We have determined that strong measures need to be taken to inform the public," he said. Woodcock, Director of the FDA's Research and Research Center. "We will continue to monitor and examine these risks associated with insomnia medications and communicate with the public or consider further actions, as necessary."
As a result of a new safety check based on reports of adverse events and other data sources, the FDA has determined that while rare and complex sleep movements associated specifically with eszopiclone, zaleplon, and zolpidem (not all sleep aids) have resulted in serious injuries and death. Specifically, the FDA reviewed 66 cases reported to the FDA on a negative reporting system or found in medical literature in which patients engaged in activities while not fully awake, such as sleepwalking or driving, resulting in severe injuries or death following insomnia, eszopiclone, Zeppelon, or zolpidem. 46 Reports of serious non-fatal injuries included excess cases of overuse, falls, burns, close drowning, exposure to extreme cold temperatures leading to organ loss or death, to self-inflicted injuries such as gunshot wounds and alleged suicide attempts. The 20 deaths reported carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal vehicle collisions with the patient driver and alleged suicide.
As a requirement for their approval, an insomnia medication should be given with a patient's medication guide explaining the drug's uses and risks. Patients should check this information every time they get refills of their drug as information may change. Health professionals should not prescribe eszopiclone, zaleplon, or zolpidem for patients who have a history of complex sleep behavior after taking these insomnia medications. Patients should be advised that rare, but serious injuries and death are possible. Patients should stop taking these drugs and contact their healthcare provider immediately if they find themselves involved in activities while they are not fully awake or do not remember activities performed while taking the drug.
Health professionals and patients should report side effects of eszopiclone, zaleplon, zolpidem, or other drugs to the FDA's MedWatch program.
The FDA, an agency within the US Department of Health and Health, protects public health by ensuring the safety, efficacy and safety of veterinary human medicines, vaccines and other biological products for human use and medical devices.The Agency is also responsible for the safety and security of the country's food supply, Cosmetics, nutritional supplements, products that distribute electronic radiation, as well as regulating tobacco products.
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SOURCE US Food and Drug Administration