The US Food and Drug Administration (FDA) is adding a boxed warning to certain sedative hypnotic medications that are commonly used for insomnia 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 new warnings will be required for eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien), according to the FDA Drug Safety Communication. The AGS Beer’s Criteria for Potentially Inappropriate Medication Use in Older Adults refers to these sedatives as the “Z-drugs.” They are nonbenzodiazepine, benzodiazepine receptor agonists. These drugs greatly increase risk of falls and other adverse effects for older adults.

Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines. The Beer’s Criteria already recommends completely avoiding these medications in older adults, and with these findings, there is even more evidence to avoid them as most older adults take at least one CNS depressant.

There were 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death. These cases 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. Patients usually did not remember these events. The underlying mechanisms by which these insomnia medicines cause complex sleep behaviors are not completely understood.  The FDA is also reminding the public that all medicines taken for insomnia can impair driving and activities that require alertness the morning after use.

These sedative hypnotic drugs are just one class of potentially inappropriate medications for elderly. Now, the Z-drugs come with even greater caution.    If you would like to learn more about what medications should be avoided in the elderly, please contact Guardian Pharmacy Atlanta and ask to speak with one of our consultant pharmacists.  They are very knowledgeable about older adults and medications that should be avoided.  They can be reached at 770-635-3301.


*Information published by the FDA Drug Safety Communication

FDA Drug Safety Communication [04-30-2019]; American Geriatrics Society 2019 Updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults