Federal Regulators To Slap Warnings On Sleeping Pills Because Of Drugs’ Risky Side Effects
The boxed warnings must list side effects such as sleepwalking and sleep driving. Although such reactions are rare, they can result in serious injuries or death.
The New York Times:
Drug Agency Calls For Strong Warning Labels On Popular Sleep Aids
Federal health regulators announced on Tuesday that they would require manufacturers of sleeping pills such as Ambien and related drugs to post strongly worded warnings in boxes on labels and patient guides. The Food and Drug Administration, in what it called a safety announcement, noted that the drugs’ side effects included risky behaviors, such as sleepwalking and sleep driving, that can lead to injury and even death. (Carey, 4/30)
The Wall Street Journal:
FDA Orders ‘Black-Box’ Warnings For Sleep Aids
The FDA said on Tuesday prescription insomnia pills that contain eszopiclone, zaleplon and zolpidem would have to display a black-box warning about potential risks and a contraindication that they shouldn’t be taken by patients who have experienced complications such as sleepwalking or driving while asleep. (Armental, 4/30)
Bloomberg:
Lunesta, Ambien Sleeping-Pill Side Effects? FDA Adds Warnings
There were 46 reports of serious injuries that weren’t deadly, including overdoses, burns, loss of limbs from extreme cold, and self-injuries from gunshot wounds. “These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses,” FDA Acting Commissioner Ned Sharpless said in a statement. “While these incidents are rare, they are serious and it’s important that patients and health-care professionals are aware of the risk.” (Cortez, 4/30)
