The US Food and Drug Administration (FDA) is adding a boxed warning to certain prescription insomnia medication following reports of injury and death resulting from sleepwalking, sleep driving, and engaging in other activities while not fully awake after taking these medicines. The medications with this added box warning include eszopiclone, zaleplon, and zolpidem. Eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep.
In addition to the boxed warning, the agency is also requiring eszopiclone, zaleplon, and zolpidem to carry a contraindication to avoid use in patients who have previously experienced an episode of complex sleep behavior with use of one of the drugs. Additionally, health care professionals should tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior and should advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death.
The FDA identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death. Methods used included the FDA Adverse Event Reporting System (FAERS) database to identify 62 cases of complex sleep behaviors that resulted in serious injuries or death after taking these insomnia medicines reported between December 16, 1992, and February 27, 2018, and an additional 4 cases were reported in the medical literature between December 16, 1992, and March 13, 2018.
Of the 66 cases, 20 cases were reported as resulting in fatal outcomes. Forty-six cases reported serious non-fatal injuries; these patients usually did not remember experiencing these complex sleep behaviors. These cases reported one or more episodes of the sleep behaviors and reported one or more adverse events. The adverse events found most often (n=22) included falls with serious injuries such as intracranial hemorrhages, vertebral fractures, and hip fractures. Other adverse events included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts. Most of these patients reported using zolpidem (n=61) when they experienced a complex sleep behavior. The remaining patients took eszopiclone (n=3) or zaleplon (n=2).
References:
>> FDA News Release
>> FDA Drug Safety Communication
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