Commentary on new FDA warning for insomnia medications

Contributed by Bryce Mander, PhD

The Food and Drug Administration (FDA) has recently required some sleep medications which are commonly used to treat insomnia to add black box warning labels.

The reason for this decision is because there have been reported incidents of individuals engaging in activities that commonly occur during wakefulness during sleep while on these medications, including sleep walking, sleep driving, sleep eating, and sleep cooking. On rare occasions, these symptoms have resulted in serious injuries or life-threatening incidents, which has led to the inclusion of the black box label. The FDA has also issued a contraindication for use of these medications in any individual that has already experienced these behaviors while taking these medications.

Since insomnia is a fairly common sleep disorder, particularly in older individuals, it is important for both the medical community and the general population at large to know that the American Academy of Sleep Medicine (AASM) has already indicated that the primary intervention for insomnia is not sleep medications but cognitive behavioral therapy for insomnia (CBT-i). Sleep medications, such as those now including black box labels, should only be implemented in those who cannot undergo CBT-i, have ongoing symptoms following CBT-i, or as a temporary adjunct supporting CBT-i. Use of such medications should only occur after careful consideration with a board certified sleep medicine specialist.

For those interested to learn more about this new black box label, please see this official statement from the AASM.

To learn more about sleep and Alzheimer’s disease, watch Dr. Mander’s recent UCI MIND Facebook LIVE series video.


Bryce Mander, PhD, is Assistant Professor of Psychiatry & Human Behavior at UCI. He received his PhD in Neuroscience at Northwestern University, and completed his postdoctoral fellowship in the Department of Psychology at UC Berkeley. His research looks at how sleep disturbance impacts brain function, thinking, and memory in older adults, particularly those at risk for dementia. In his studies, he combines the use of multiple brain imaging tools, such as MRI, EEG, and PET, with behavioral testing to uncover the mechanisms linking sleep disturbance to cognitive decline in later life. Dr. Mander is one of the fields leading experts in the neuroscience of sleep and has published many important findings on the link between sleep and brain health.

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