After a multitude of serious and rather unusual adverse events being reported with the use of certain prescription medications for insomnia, the Food and Drug Administration (FDA) has issued black box warnings with their use.  These warnings, the strongest the FDA can issue, apply to eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist).
 
Several very concerning and unusual events were reported to the FDA, which ultimately led them to issue the warning.  In total, the FDA reviewed 66 specific cases, 20 of which resulted in death. Sleepwalking and sleep driving were widely reported via medical and media outlets, but additional events included dangers of performing activities when not fully awake.  Unsafe use of a stove, carbon monoxide poisoning, drowning, falls, burns, hypothermia (including cold temperature exposure leading to loss of limb), self-injury (gun shot wounds), and suicide were all reported to be linked with the use of the prescription sleep aids listed above. Per the FDA, these events took place in patients taking medications for the first time, as well as those who had already been taking them for extended periods of time.  In addition, the reactions were not dose dependent, occurring even at the lowest recommended doses.
 
In addition to the black box warning, the FDA is requiring that these medications include language contraindicating their use in those patients who experience such episodes of “complex sleep behaviors” after use.  Although these cautions existed in the product labeling before, the actions now being taken by the FDA are intended to strengthen the significance, “to make the warning more prominent and reflect the risk of serious injury and death.”
 
Safe prescribing of these medications must take place.  Any patient with prior history of complex sleep behaviors after using eszopiclone, zaleplon, or zolpidem should not have repeated use with the offending agent or with any of the other listed entities.  Patients must be counseled on these possible reactions prior to use, and should be told to immediately cease use and report such events to their health care professional in the event they occur.  As a part of these medications’ approval, patients are dispensed a medication guide from the pharmacy at the time of dispensing warning of these possible side effects, however this should not substitute for discussion and counseling at the time of dispensing. 
 
To read the FDA’s news release regarding these updates, click here.

Any serious, unexpected adverse reaction to any of the above medications should as always be reported to the FDA via their MedWatch program.  To be directed to this program, click here.