The Food and Drug Administration has issued a black box warning for the most popular sleeping pills on the market. This is the heaviest tool in the FDA’s toolkit, short of banning a medicine outright. It represents the agency’s ultimate caution. The FDA’s black box warning is descried this way:

“It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.”

Here is the FDA’s black box warning announcement from (April 30, 2019):

“The Food and Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths.”

Who Reads the FDA’s Black Box Warning?

Sadly, the FDA’s black box warning is not as easily accessed as one might think. If an official prescribing “label” is glued to your bottle of pills, it is on a piece of paper that has been folded up so many times that it is hard to read. It is written in official FDA medical jargon. We suspect that many people throw it away without even glancing at it.

The piece of paper the pharmacy may include with your bag of pills is not the actual FDA official prescribing information. It is a summary the pharmacy prepares or contracts from another source. The electronic version is not always easy for patients to access. Doctors and pharmacists are not required to mention the black box warning.

It is not clear how many people are actually notified about a black box warning. We don’t even know whether health professionals are always aware that a black box warning exists for a medicine they are prescribing.

FDA’s Black Box Warning for Ambien, Sonata and Lunesta:

The FDA approved Ambien (zolpidem) in December 1992. Sonata (zaleplon) got the green light in August 1999. The last of the “Z” drugs, Lunesta (eszopiclone), got its FDA go-ahead in December 2004. Over the decades, millions of people have taken these popular sleeping pills.

There have been rumors of unusual problems associated with these drugs for a very long time. Readers shared stories about finding food in bed with them. They could not remember getting up, going to the refrigerator, making a sandwich and then taking it back to bed.

One man became convinced that his neighbors had abducted his brother and locked him in the trunk of their car. He was jumping up and down on the trunk of the car trying to get his brother out when the police arrived. Not only did they arrest him, but he had to pay for the damage to the vehicle. He was surprised when his brother was not in the trunk. The next day he remembered nothing of the incident.

The drug safety communication from the FDA notes:

“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.”

“Complex sleep behaviors” include sleep walking, sleep eating, sleep talking, sleep internet browsing, sleep sex and sleep driving. You might find it hard to believe that someone would get out of bed, take their keys from a drawer, climb into a car and start driving without being fully awake. But so many people have reported this kind of activity that the FDA has taken it very seriously. Needless to say, driving or walking while asleep can result in serious injuries or death.

The FDA’s Cases:

The Food and Drug Administration describes the following serious complications associated with Z-drugs:

“The adverse events included falls (n=22) with serious injuries such as intracranial hemorrhages, vertebral fractures, and hip fractures. Other events included self-injuries (n=7), fatal falls (n=6), accidental overdoses (n=5), hypothermia (n=5), suicide attempts (n=5), apparent completed suicides (n=4), fatal motor vehicle collisions (n=4), gunshot wounds (n=3), carbon monoxide poisoning (2), drowning or near drowning (n=2), burns (n=2), and homicide (n=1).”

We doubt that very many people have successfully overturned a charge of DUI by offering a Z-drug defense. Ditto for damage to property or homicide. Judges have a hard time believing that someone could commit a crime because of a medication.

FDA’s Cautions:

Here is what the FDA tells physicians and patients about Z-drugs:

“Health care professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death. Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior.

“Patients should stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine.”

Be Careful:

The FDA’s warning goes on to say:

Never stop taking a Z-drug suddenly. We worry about withdrawal symptoms, including rebound insomnia. Always discuss your situation with the prescriber. If it is appropriate to discontinue a drug like zolpidem or eszopiclone, you may need to do so very gradually over several weeks or months. The health professional who prescribed the sleeping pill may need to do some research to discover the best way to phase off such a medicine.

To learn about other ways to deal with insomnia, we offer our eGuide to Getting a Good Night’s Sleep.

Share your own story about zaleplon, zolpidem or eszopiclone in the comment section below.

“• These events can occur with just one dose of these medicines as well as after a longer duration of treatment.
• If you experience a complex sleep behavior, stop taking the medicine and contact your prescriber immediately.
• FDA is also reminding the public that all medicines taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the prescribing information of all insomnia medicines, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia medicines can experience impairment of mental alertness the morning after use, even if they feel fully awake.”

What Else Can You Do?

Related People's Pharmacy Health Guide

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