FDA strengthening warning for some popular sleeping pills after serious injury, deaths reported

Prescription bottles. (Shutterstock / David Smart)

(WTHR) – The Food and Drug Administration is strengthening the warnings on some of their most popularly used sleeping pills.

Sleeping pills under the names Lunesta, Sonata and Ambien, as well as three formulations of zolpidem (the generic name for Ambien) will require new black-box warnings for potentially dangerous side-effects.

According to the FDA, these common insomnia prescriptions have caused serious injury and even death from side effects like sleepwalking, sleep driving, and engaging in other activities while not fully awake.

The FDA says the side-effects of the sleeping pills have resulted in 20 deaths.

“These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts,” the agency reported. “Patients usually did not remember these events.”

The new 'Boxed Warning' that is required for the sleeping medications, must be added to the prescribing information and the patient Medication Guides for these medicines. The FDA is also requiring a 'Contraindication', their strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.

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