FDA adds Boxed Warning for risk of serious injuries due to complex sleep behaviors with insomnia medicines

In a safety communication, the US Food and Drug Administration (FDA) has added a Boxed Warning, its most prominent warning, to the prescribing information and the patient Medication Guides for some common prescription insomnia medicines.

Additionally, the FDA now also requires a Contraindication, its strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior.

This warning comes after reports of rare but serious injuries that have happened with common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. In some cases, these complex sleep behaviors have been fatal.

These sleep behaviors are more common 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.

(Source: US FDA, April 30, 2019)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA