by John Gever: For More Info, Go Here…
FDA worries that current labels weren’t emphatic enough about dangerous side effects.
Since current label warnings on sleep medications such as zolpidem (Ambien) and eszopiclone (Lunesta) don’t seem to have prevented “sleep driving” and other dangerous effects, the FDA said it will now put a black box around those warnings.
Currently, warnings about so-called complex behaviors associated with these medications are buried in section 5.4 of the single-spaced, small-print drug label. Such behaviors include driving, preparing foods, having sex, and making phone calls while not fully awake.
The agency’s new safety announcement noted that these can have serious and even fatal consequences. It listed nearly 20 fatal incidents involving falls, motor vehicle crashes, guns, and drowning. One homicide while under the influence was reported to the FDA. Most of the approximately 70 serious incidents occurred in patients using zolpidem. Relatively few were among those taking eszopiclone or zaleplon (Sonata), but “these data are consistent with the higher number of zolpidem prescriptions dispensed” compared with the other drugs.
