The US Food and Drug Administration on April 30, 2019 required revised warnings on a host of popular and often used sleep aides warning of a whole host of dangerous risks that have been linked to the drugs.
The drugs, such as Lunesta and Ambien, have been linked to 66 examples of patients who took the drugs and engaged in dangerous activities such as sleepwalking or driving while not fully awake, including 20 deaths linked to carbon monoxide poisoning, drowning, fatal falls, hypothermia, car crashes and apparent suicide.
As a result, the FDA has required a black box warning to be added to the prescription medications, the strongest warning by the FDA.
The FDA alert states in part:
The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.
As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.
Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.
Go here to see the entire FDA warning.
