FDA Orders Black Box Warning for Popular Insomnia Drugs

The Food and Drug Administration has required the strictest warning label available to the three most prescribed insomnia drugs. This action serves to attract attention to side effects with potentially life-threatening consequences. Driving and cooking are among examples of behaviors causing injury and death in patients. The FDA was prompted to take action after reports of these activities being carried out while patients are sleeping or not entirely awake resulting in serious consequences.


The drugs named are eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien is the most common but it is marketed under other names.) Patients will also be advised to avoid taking these medications if they have experienced any of the troubling symptoms. The FDA acknowledges that complications of these drugs are rare but they are dangerous when they do arise. It is imperative that health care professionals and patients are aware of the risks associated with these drugs.


Reports of unusual behavior linked to the drugs prompted the FDA to take this step. Over 40 serious injuries were reported in a recent review of 66 cases. These injuries included individuals who lost a limb to frostbite, almost froze to death, shot themselves or nearly drowned. Deaths from drowning, fatal automobile accidents, possible suicides, and carbon monoxide poisoning were reported as causes of death in 20 cases. There have also been reports of homicides while under the influence of Ambien.


There does not seem to be a pattern to determine which patients are at higher risk for these side effects. Incidents occur after long periods of treatment with these drugs and also after the first dose. Even at the lowest recommended doses, some people experience complications when they have no history of this kind of behavior.


Drug companies have consistently reassured the public of the safety of these drugs but the FDA’s careful monitoring of the situation has increased over the last several years. Similar but less prominent warnings were put into place for these drugs in 2007 and in 2013 recommended doses for women were lowered. Continued monitoring will be in place to evaluate risks and the FDA will communicate any findings with the public when appropriate.

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