A new consumer update issued by the US Food and Drug Administration (FDA) cautions against the risks of complex sleep behaviors associated with prescription medications for insomnia including eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edlura, and Zolpimist), sometimes known as “Z-drugs.” 

Prescription Z-drugs work by slowing activity in the brain. Used properly, they can help users sleep, but the treatments also carry the risk—though rare—of serious injuries and even death. 

In 2019, the FDA required the addition of the risks for complex sleep behaviors resulting in serious injuries or death to the labeling and Patient Medication Guides for all prescription 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 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.

People might not remember these behaviors when they wake up the next morning. Moreover, they may experience these types of behaviors after their first dose of one of these Z-drugs, or after continued use.

Tips for Taking Medicines for Insomnia

According to the FDA’s consumer update, patients should discuss the benefits and risks associated with Z-drugs if prescribed. 

The FDA shared the following tips: 

  • Be sure to read the patient medication guide as soon as you get the prescription filled and before you start taking the medicine. If you have any questions or don’t understand something, ask your health care professional.
  • After taking the medicine, if you experience a complex sleep behavior, stop taking the drug and contact your health care professional immediately.
  • Complex sleep behaviors can occur at lower dosages, not just high doses. It’s important to carefully follow the dosing instructions as directed by your health care professional.
  • Don’t take these medicines with any other sleep drugs, including those you can buy over the counter without a prescription.
  • Don’t drink alcohol before or while taking these medicines; together they may be more likely to cause side effects.
  • You may still feel drowsy the day after taking one of these drugs. Keep in mind that all insomnia medicines can impair your ability to drive and activities that require alertness the morning after use.

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