In a recent consumer alert, the U.S. Food and Drug Administration (FDA) has warned patients about the potential risks associated with prescription sleep aids known as "Z-drugs." These medications, including eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist), are often prescribed to treat insomnia.

While these medications are FDA-approved and can help patients fall and stay asleep by slowing down brain activity, there is a rare but serious risk of injuries and even death. The FDA has revealed that they have received reports of various complex sleep behaviors occurring after the use of Z-drugs, including sleepwalking, sleep driving, sleep cooking, and taking other medicines.

In their most recent alert, the FDA highlighted the findings of their review, which included 66 cases of complex sleep behaviors associated with Z-drugs. Among these cases, there were 46 reports of non-fatal serious injuries involving accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds, and apparent suicide attempts. Additionally, there were 20 reported deaths related to complex sleep behaviors, including carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions, and apparent suicide.

This is not the first time the FDA has raised concerns over the safety of Z-drugs. In April 2019, they required these medications to include a boxed warning, which is the highest safety-related warning that the FDA can enforce. The warning aims to inform patients about the potential risks associated with these sleep aids.

With approximately 50 to 70 million people suffering from sleep disorders in the U.S., insomnia being the most common, Z-drugs have become a popular choice for treatment. However, due to the limited understanding of the underlying mechanisms behind the occurrence of complex sleep behaviors with these medications, the FDA emphasizes the importance of patients being aware of the potentially fatal consequences.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, noted the agency's commitment to monitoring and evaluating these risks associated with insomnia medications. The FDA also intends to communicate with the public and take further actions, if necessary, to ensure patient safety.

For individuals who are prescribed Z-drugs, it is crucial to be informed and take precautions. Patients are advised to carefully read the medication's accompanying information, be aware of the potential sleep-related behaviors, and consult their healthcare providers for any concerns or questions.

Sleep is essential for both physical and mental health, and while Z-drugs can be effective in treating insomnia, patients need to be aware of the associated risks. The FDA's warning serves as a reminder to prioritize safety and make informed decisions when it comes to sleep aid medications.