Ambien, Other Sleep Aids Get FDA’s ‘Black Box’ Label, Its Strongest Warning
Ambien and other prescription sleep medications are getting a new “black box” warning label from the U.S. Food and Drug Association (FDA). This type of label is the strongest that the agency issues, calling attention to side effects that can lead to serious injury or death.
The change follows the FDA’s evaluation of reports describing “rare but serious” incidents that occurred when users of these medications experienced complex sleep behaviors: sleepwalking, sleep driving “and engaging in other activities while not fully awake,” FDA representatives wrote yesterday (April 30) in a drug safety announcement.
A prominent boxed warning will now appear on patient medication guides and prescription information for insomnia drugs such as Ambien (generic name zolpidem), Sonata (generic name zaleplon), Lunesta (generic name eszopiclone) and others, according to the announcement. [7 Bizarre Drug Side Effects]