What If Your Medication Carries a Black Box Warning?

In March of 2018, I wrote a blog called Black Box Warnings that explains, when the FDA approves drugs that can cause significant harm, it may require that their labels include a warning about those risks. Those are called black box warnings.

My blog discusses why it may be in a patient’s best interest to take the medication, even though it does carry significant risks. It emphasizes the doctor’s role in consultation with the patient to decide whether or not the potential benefits of the drug are worth risking the harm that it may cause.

The FDA Warns About Sleeping Medication

However, what should you do if the FDA issues a new warning about a medication you are already taking? According to CBS News, the FDA has just decided that common prescription sleeping drugs, including Ambien, Lunesta and Sonata, must include a black box warning.

Typically, during sleep, we cycle through five stages. During the final stage — Rapid Eye Movement (REM) — our bodies are relaxed but immobilized. This is the stage of sleep during which we are most likely to dream, and our bodies cannot move for our own protection. This prevents us from acting out the things about which we are dreaming.

For example, you may have a nightmare about an intruder in your home threatening harm to your family. The paralysis accompanies REM sleep to ensure that you don’t act out in a way that could be harmful to your bed partner or yourself.

For some patients, though, sleeping medication interferes with their natural sleep cycles and paralysis. It may cause them to awaken suddenly but not fully. Their bodies would not be paralyzed, and they may engage in dangerous behaviors such as driving or walking when they are not fully awake. CBS News reports that this has resulted in “falls, burns, near-drowning, car crashes, or lost limbs after exposure to extreme cold temperatures.”

According to the FDA, these side effects are rare. People with complex sleep behavior, such as sleepwalking or opening doors, are more likely than the general population to be harmed by prescription sleeping medications.

Benefits May Outweigh Risks

While the black box warnings on the labels of sleep medications may be new, the risks they carry are not. The chemicals of the medication have not changed. If you have been benefiting from sleeping pills, you should not suddenly discontinue using them. However, you should discuss the reasons for the black box warning with your doctor as soon as possible.

Black box warnings may be alarming. However, they are not meant to scare you into panicking and discontinuing medication that you need. Their primary purpose is to inform prescribers and patients about dangers they may pose.

All medications have risks. It is important that patients are fully informed about the potential risks and potential benefits before beginning, or deciding to continue, any medication.