FDA: Taking Z-drugs for Insomnia? Know the Risks


ZZZZZ. Remember sleeping through the night? Not lately?

If you’re lying awake night after night, unable to sleep, you may want to talk to your health care professional about it. They may prescribe insomnia medicines approved by the U.S. Food and Drug Administration, such as eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist). Sometimes known as “Z-drugs,” they might help you get a good night’s sleep. But as with any medicine, there are risks.

Prescription Z-drugs work by slowing activity in the brain. Used properly, they can help you sleep. Quality sleep can have a positive impact on physical and mental health. But the treatments also carry the risk – though rare – of serious injuries, and even death. Be aware of these risks.

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.

What Are Complex Sleep Behaviors?

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

If your health care professional prescribes a Z-drug to help you sleep, discuss with them the benefits and risks.

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.

Source: https://www.fda.gov/consumers/consumer-updates/taking-z-drugs-insomnia-know-risks