Drugs/Therapy

FDA Warns of Sleep Drugs That Could Cause ‘Serious Injuries’

By Corazon Victorino | Update Date: Apr 08, 2024 11:37 PM EDT

The U.S. Food and Drug Administration (FDA) has cautioned patients prescribed Z-drugs-eszopiclone, zaleplon and zolpidem-for insomnia about the potential for serious injuries associated with these medications.

While the drugs are approved by the FDA to aid sleep by slowing brain activity, they also carry rare but significant risks, including complex sleep behaviors, as highlighted in the agency's March 6 alert.

The FDA emphasized in a consumer alert the importance of discussing the benefits and risks of these medications with healthcare providers and carefully adhering to dosing instructions.

Patients were advised to avoid combining Z-drugs with other sleep medications or alcohol, which may exacerbate side effects.

Furthermore, people experiencing complex sleep behaviors, such as sleepwalking or sleep cooking, were urged to discontinue medication use and seek medical attention promptly.

The agency's warning stems from reports of non-fatal serious injuries and fatalities associated with complex sleep behaviors observed in patients taking Z-drugs.

"Complex sleep behaviors occur while you are not fully awake. Examples include sleepwalking, sleep driving, sleep cooking, or taking other medicines," the FDA stated.

"The FDA has received reports of people taking these insomnia medicines and accidentally overdosing, falling, being burned, shooting themselves, and wandering outside in extremely cold weather, among other incidents."

Despite these risks, Z-drugs remain commonly prescribed for insomnia, affecting millions of individuals in the U.S. alone.

Patients are encouraged to stay informed and vigilant about potential adverse effects, prioritizing open communication with healthcare providers and prompt reporting of any concerning symptoms or experiences.

"Patients should stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine," the agency cautioned, according to Best Life.

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