WASHINGTON -- 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 .
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.
"As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines," the FDA said. "We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem."
This is the second time the FDA has sought to stiffen warnings about these adverse effects. In 2007, it told drugmakers to include information about "sleep driving." Then in 2013, the agency ordered lower dosing recommendations for zolpidem in response to reports of such behaviors the morning after patients had taken the drug.
In the new announcement, the agency reiterated that morning-after drowsiness is common with these drugs and that patients should exercise caution when driving and other tasks requiring full alertness.