We all know how important it is to get eight hours of sleep each night, but it’s easier said than done. For some reason, you may find yourself unable to relax and tossing and turning. In that case, your doctor may prescribe medication to treat insomnia. Some of these sleep aids are known as “Z-drugs.” These include eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edlure, Zolpimist). But while these prescriptions have been approved by the U.S. Food and Drug Administration (FDA), the agency is now warning patients that they carry a “risk of serious injury.”
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in Consumer warning In a March 6 post, the FDA explained that prescription Z drugs work by slowing brain activity, helping you fall asleep and stay asleep.
“Quality sleep can have positive effects on physical and mental health,” the agency said in its warning. “However, this treatment also carries the risk, although rare, of serious injury or even death.”
This isn’t the first time the FDA has sounded the alarm on Z drugs. The agency announced this in April 2019. you will start to need Certain prescription insomnia drugs now include new “boxed warnings” about potential risks. The boxed warning isHIGHEST SAFETY WARNING” According to the National Institutes of Health (NIH), the FDA can require drugs to include it.
According to the FDA, the additional boxed warnings were prompted by reports of serious injuries and deaths that occurred as a result of various complex sleep behaviors after using these drugs.
“Complex sleep behaviors occur while you are not fully awake,” the agency explained in its latest alert. “Examples include sleepwalking, drowsy driving, drowsy cooking, and taking other medications.”
The FDA investigated 66 cases related to these complex sleep behaviors due to Z drugs and found that “exposure to extreme cold temperatures leading to accidental overdose, falls, burns, near drowning, and loss of limbs” It found there were 46 reports of serious non-fatal injuries, including: or near death, self-inflicted injuries such as gunshot wounds, and what appears to be a suicide attempt. ”
According to the agency, 20 cases of death due to complex sleep behavior due to “carbon monoxide poisoning, drowning, death from falling, hypothermia, fatal car collision with patient while driving, and apparent suicide” have also been reported. ing.
“We have closely monitored the safety profile of these drugs since they were approved. Recently, ongoing safety monitoring has shown that patients taking these drugs develop complex sleep behaviors. Reflecting the risk of more serious injury or death if this occurs, we have decided that we need to take stronger measures to inform the public. ” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a 2019 statement. “We will continue to monitor and assess the risks associated with insomnia medications and will communicate with the public or consider further action as appropriate.”
about 50 million to 70 million According to the American Sleep Apnea Association, people in the United States suffer from sleep disorders, the most common of which is insomnia. Many of them may be taking Z drugs, especially as health care professionals have become increasingly concerned about the potential dependence of benzodiazepines, another class of prescription sleeping pills.
However, because “the underlying mechanisms by which these insomnia drugs cause complex sleep behaviors are not fully understood,” the FDA says that taking Z drugs can have potentially fatal consequences. He says it is important to make patients aware of this. To keep yourself safe, read the authorities’ advice for people prescribed these medicines.
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Nearly 30 million total prescriptions for zolpidem, eszopiclone, and zaleplon distributed from U.S. retail pharmacies in 2018, according to the FDA. If you end up being prescribed Z drugs to help you sleep, it’s important to discuss the benefits and risks of these drugs with your health care provider right away, the agency said.
“Be sure to read the Patient Medication Guide as soon as you receive your prescription and before you start taking the drug,” the FDA advises in its latest warning. “If you have questions or don’t understand something, please ask a health care professional.”
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There is no specific pattern for how complex sleep behaviors are caused by Z-drugs. According to the FDA, these symptoms occur with both high and low doses, as well as after one dose of these drugs and after long-term treatment. With that in mind, the agency said it is important that patients carefully follow the specific dosing instructions given by their doctor.
“Use insomnia medications as directed,” the FDA warned. “To reduce the possibility of side effects or adverse events, never take more than the prescribed amount or more often than prescribed.”
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If you are prescribed zolpidem, eszopiclone, or zaleplon, there are some things you should avoid. The FDA said patients should not take these drugs with other sleeping pills. This includes over-the-counter sleeping pills, such as melatonin, which can be purchased without a prescription.
At the same time, you should not drink alcohol before or while taking Z-drugs.
“Combining these may increase the likelihood of causing side effects,” the agency explained.
The FDA advises health care professionals to tell patients to discontinue insomnia medications if they experience episodes of complex sleep behavior, even if they are not seriously injured.
“If patients develop complex sleep behaviors in which they perform activities while not fully awake, or if they do not remember the activities they performed while taking the medication, patients should stop taking their insomnia medication and seek immediate medical attention. You should contact a specialist,” the agency said.
Health care professionals are also warned by the FDA not to prescribe eszopiclone, zaleplon, or zolpidem to anyone who has previously experienced complex sleep behavior after taking any of these Z drugs. Masu.
While Best Life provides the latest information from leading experts, new research, and health organizations, our content is not a substitute for professional guidance. Always talk directly to your health care provider about any medications you are taking or any other health questions you may have.
