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 FDA Alerts
April 29, 2024

Advice From FDA: Know the Risks of Taking Prescription Medicine for Insomnia

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People who struggle night after night to fall asleep, stay asleep, or get a good night's rest may have a sleep disorder known as insomnia. Symptoms of insomnia can include daytime sleepiness or feelings of depression, anxiety, and agitation. If insomnia continues without treatment, it may become more difficult to focus on important tasks and may result in harm to you or others.

It is important to talk to your healthcare provider about your sleeping habits. If you are diagnosed with insomnia, your doctor may prescribe a medicine to treat it. These medicines, sometimes referred to as "Z-drugs,” include eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar). While these medicines may improve your night’s rest, there are potential risks involved, including serious injury and even death.

Prescription “Z-drugs” work by reducing brain activity which helps you sleep. However, in rare cases, they may cause sleep behaviors that usually occur during wakefulness. For example, people may engage in activities such as sleepwalking, sleep driving, sleep cooking, or taking other medicines during their sleep. These behaviors are referred to as complex sleep behaviors (CSBs). The US Food and Drug Administration (FDA) has received reports of people taking “Z-drugs” and engaging in dangerous and deadly activities while sleeping, such as wandering outside in extremely cold weather, accidentally overdosing, falling, being burned, and shooting themselves. People may not remember doing these things when they wake up the next morning. This behavior can occur after the first dose of a “Z-drug” or after continued use. In 2019, FDA required the package labeling and the Patient Medication Guide for all prescription “Z-drugs” to include the risk for CSBs.

Here's what you can do:

  • If you are prescribed a “Z-drug” to help you sleep, talk to your doctor about the benefits and risks of taking the medicine.
  • If you take a “Z-drug” be sure to:
    • Get a Patient Medication Guide when you pick up the medicine at the pharmacy. Read the information before taking the medicine. If you have any questions or don’t understand something, ask your pharmacist or other health care professional.
    • Do not drink alcohol or take any other sleep medicine, including those you can buy over the counter (OTC), with a “Z-drug.” This can increase the chance of side effects.
    • If you experience a CSB when using a “Z-drug” you should stop taking the medicine and contact your health care professional right away.
  • Keep the following in mind:
    • Be sure to carefully follow the dosing instructions on your prescription label.
    • CSBs can occur after the first dose or after continued use.
    • Be aware the following day of taking these medicines, you may experience daytime sleepiness. Use caution withactivities that require you to be alert until you no longer feel the effects of the medicine.  

Advice from FDA is a feature brought to you by the FDA. You can find this information and more on FDA’s Consumer Health Information website. This website features the latest updates on medicines and products regulated by the FDA. Sign up to receive a free FDA Consumer Update subscription.

Published April 29, 2024

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Advice From FDA: Know the Risks of Taking Prescription Medicine for Insomnia