What are black box warnings on sleep medications?

In April 2019, the Food and Drug Administration announced additional warnings on a group of prescription medications designed for patients with insomnia. These warnings are sometimes referred to as “black box warnings” because of their prominent display on package inserts. The side effects in question weren’t new. The warnings are simply a way to draw prescriber and consumer attention to specific side effects that are sometimes overlooked.

Prior to FDA approval, new medications are put through a rigorous process by pharmaceutical manufacturers. Common side effects are easily identified. They’re listed on package inserts to make prescribers aware of possible side effects patients may experience and warn of potential drug interactions. Rare and sometimes more serious side effects may go unnoticed or the risks may not be appreciated until after products come to market. When more people experience a more serious side effect, the FDA will sometimes issue a black box warning to prescribers.

An excellent example of this is a warning now on anti-depressant medications about an increased risk for suicidal thoughts and behaviors. This warning isn’t specific to a particular drug, but rather a class of medications. That’s what happened with this group of insomnia medications. Because they share the same mechanism for effectiveness, they pose the same potential risk.

The serious side effect of sleep medications now highlighted by the FDA is specifically for complex sleep-walking behaviors.

Sleepwalking isn’t rare and is generally benign. Typical sleepwalkers aren’t sophisticated; they meander—a little zombie-like. We don’t yet know why, but these medications can cause sleepwalkers to participate in more complicated activities and not wake up. That’s the unusual situation with these drugs.

Importantly, in this group of individuals, once the side effect occurs, it will keep happening. Individuals who take these medications should be aware that they should stop taking them immediately if this occurs. Patients have been found walking down the street or driving, for example. There’s then the added danger of accidents, although falling and getting injured indoors is more common.

Typically, any sleep provider would already be aware of the risks. For an appropriately selected patient, the risks are quite low. People who have trouble sleeping because of stress or other worries have many options for short-term treatments to aid rest. Long-term usage increases the risk for complications.

Because these medications are advertised as a treatment for patients who have trouble sleeping, some people may go to their general practitioner and ask for them, but that doesn’t address underlying causes of insomnia. A thorough evaluation by a sleep specialist can help determine the cause of difficulties with sleeping and reduce the risk for adverse events related to this class of medications.

Before I start my patients on any sleep medications, I look for indications of a group of conditions called parasomnias, as well as other sleep disorders. These occur during the transition from being asleep to being awake, and may include sleep walking, sleep eating and night terrors. Most people experience these in childhood and outgrow them as they reach adulthood. Interestingly, there’s a genetic predisposition to developing parasomnias. If you experienced it, there’s a 40% chance one of your kids will experience it.

If you’ve tried sleep aids and they don’t work—there’s a reason. You should get a referral, if necessary, and make an appointment with a competent sleep specialist. They can exclude many causes of insomnia, which may be a symptom of other medical conditions.


Jesse Mindel is a neurologist and sleep specialist at The Ohio State University Wexner Medical Center.