Ambien and other insomnia meds to be labelled with black box warnings after sleepwalking deaths
pharmafile | May 2, 2019 | News story | Medical Communications, Research and Development | FDA, ambien, black box warning, insomnia, sleeping pills, warning label
The FDA has said that Ambien, and other insomnia medications, must be labelled with a ‘black box warning’ – the most strongly worded warning issued by the FDA.
Sleeping pills (Ambien, Lunesta and Sonata) will be labelled with a ‘boxed warning,’ after a number of incidents involving sleepwalking, sleep driving and other sleep activities, resulted in serious injury or death.
The FDA has, in the past 26 years, recorded 66 incidents in which patients taking sleeping pills had engaged in sleep behaviours which had resulted in serious injury or death.
“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 FDA said. Patients did not usually remember these events.
Meanwhile, the FDA warned that these reports only included those incidents that had either been reported in medical literature or filed to the FDA, and that the true number could be significantly higher.
The incidents have occurred in both patients with and without a history of such behaviours, even at the lowest recommended doses.
The FDA is thus asking helathcare professionals not to prescribe the medicines to patients who have experienced complex sleep behaviours, while also advising patients to stop taking insomnia medicines if they experience complex sleep behaviours under the influence of the drugs.
Louis Goss
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