The FDA issues a new alert on the "risk of serious injury" of sleep drugs
The agency warns that millions of people may be at risk of consequences.
We all know how important it is for us to get these eight hours sleep - But it's often easier to say than to do. For one reason or another, you could find yourself launching and turning instead of being able to relax. And if this is the case, your doctor may prescribe medication to treat your insomnia. Some of these sleeping pills are known as the "Z-repeated" and include Eszopiclone (Lunesta), Zaleplon (Sonata) and Zolpidem (Ambien, Ambien Cr, Edluar and Zolpimist). But although these prescriptions are approved by the Food and Drug Administration of the United States (FDA), they have a "risk of serious injury", which the agency now warns patients.
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In a consumer alert Published on March 6, the FDA explained that prescription ZZ-logues work by slowing the activity in the brain, which can help you fall and stay asleep.
"Quality sleep can have a positive impact on physical and mental health," said the agency in its alert. "But the treatments also include the risk - although rare - of serious injuries, and even death."
This is not the first time that the FDA has sounded the alarm on the Z-repeats. In April 2019, the agency announced that it would start to demand That some prescription insomnia drugs include a new "box warning" on potential risks. A box warning is " highest security warning "That the FDA can require drugs to include, according to the National Institutes of Health (NIH).
According to the FDA, the additional box warning was caused by serious injury reports and deaths that occurred following various complex sleep behaviors after using these drugs.
"Complex sleep behaviors occur while you are not fully awake," said the agency in its last alert. "Examples include sleepwalking, sleep driving, sleep cooking or taking other drugs."
The FDA examined 66 cases linked to these complex sleep behaviors from Z-repeat, and found 46 reports of non-fatal serious injuries which included "accidental overdoses, falls, burns, exposure close, exposure to Extreme cold temperatures resulting in a loss of members or near death, self-compliance such as bullet injuries and apparent suicide attempts. "
There have also been 20 reported deaths of complex sleep behaviors that occurred by "carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal collisions of motor vehicles with the patient driven and Apparent suicide ", according to the agency.
"We looked closely at the safety profile of these drugs because they were approved. When our continuous safety surveillance recently reflected the risk of more serious injury and death of these patients who have experienced complex sleep behaviors, We determined that it was necessary to take stronger steps to inform the public, " Janet Woodcock , MD, director of the Center for Drug Evaluation and Research of the FDA, said in a 2019 statement. "We will continue to monitor and assess these risks associated with insomnia drugs and communicate with the public or to consider d 'Other actions, if applicable. "
About 50 to 70 million In the United States, people suffer from sleep disorders, the most common being insomnia, according to the American Sleep apneaa association. Many of them can take ZZ-repeat to help, especially since health providers have become more concerned with the potential dependence of benzodiazepines, another type of prescription sleeping pills.
But as the "underlying mechanisms by which these insomnia drugs cause complex sleep behaviors are not fully understood", the FDA says it is important that patients are aware of the potentially fatal consequences of taking medication z. To help you protect yourself, read the rest for the agency's advice to anyone who prescribed these drugs.
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1 Talk to your doctor risks.
In total, nearly 30 million ordinances from Zolpidem, Eszopiclone and Zaleplon were distributed Retail pharmacies in the United States in 2018, according to the FDA. If you end up being prescribed a Z-Medicism to help you sleep, the agency said it is crucial that you are talking about the advantages and risks of these drugs with your health care provider from the start.
"Make sure you read the Patient Medicines Guide as soon as you get the prescription filled and before starting to take the medication," said the FDA in its new alert. "If you have any questions or don't understand something, ask your health professional."
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2 Follow your specific dosage instructions.
There is no concrete diagram in the way sleep behaviors can come from Z-Rods. According to the FDA, they occur in high and low doses, as well as after a single dose of these drugs or after a longer treatment period. In this spirit, the agency said it was important for patients to carefully follow the specific dosage instructions given to them by their own doctor.
"Use your insomnia medication exactly as indicated," said the FDA. "To reduce the chances of side effects and undesirable events, never take more than prescribed and do not take it more often than prescribed."
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3 Do not use other sleep or alcohol drugs at the same time.
If you have been prescribed by Zolpidem, Eszopiclone or Zaleplon, there are certain things that you should also avoid. The FDA said that patients should never take these drugs with other sleep drugs - and which includes free sleep aid that you can buy without prescription, such as melatonin.
At the same time, you should not drink alcohol before or taking Z drugs.
"Together, they may be more likely to cause side effects," said the agency.
4 Stop taking these drugs if you feel a complex sleep behavior.
The FDA advises health professionals to tell patients that they should interrupt the use of their insomnia medication if they undergo an episode of complex sleep behavior - even if it has not caused serious injuries.
"Patients should stop taking your drug against insomnia and contact your health professional immediately if you feel a complex sleep behavior where you are committed to activities while you are not fully awake or if you do not Do not remember the activities you have done by taking the medication, "the agency said.
Health professionals are also warned by the FDA not to prescribe Eszopiclone, Zaleplon or Zolpidem to anyone who has already experienced complex sleep behaviors after having taken one of these Z-repeats.
Best Life offers the most up -to -date information for high -level experts, new research and health agencies, but our content is not supposed to replace professional advice. Regarding the medication you take or any other health issue you have, always consult your health care provider directly.
