What You Need to Know About the FDA’s New Warning For Sleep Medication

What you need to know about the FDA’s new warning for sleep medication

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This is not medical advice, but it is information you can use as a conversation-starter with your physician at your next appointment.

I don’t talk a whole lot about prescription sleep medications here. That’s because I am interested in addressing the root causes of sleep problems, and helping people achieve the natural, lasting improvements to sleep that come from awareness of how sleep and the body’s daily bio cycles really work. Prescription sleep medications, while they can be effective and I do believe there is a place for them in treating certain sleep disorders, in many cases these interventions do not address the underlying issues and health conditions that fuel sleep problems. The more scientific evidence we gather about prescription sleep medications, the more serious their risks appear to be. At the same time, research is also increasingly showing the limits of their benefits—and the superior effects of non-pharmacological treatments such as cognitive behavioral therapy, supplementation and bright light therapy.

Today, I am talking about prescription sleep meds because of new warnings issued by the Food and Drug Administration for several prescription medications commonly used to treat insomnia.

This is important information that everyone needs to know.

New FDA warnings forpopular sleep medications

The FDA just recently announced it will now require it’s strictest, most visible warning label for three common prescription sleep medicines: eszopiclone, zaleplon, and zolpidem. These drugs are found in several of the most commonly used sleep medications, including:

Lunesta           (eszopiclone)

Sonata             (zaleplon)


Ambien CR

Edluar            (zolpidem)



All three drugs are what’s known as sedative non-benzodiazepine hypnotics. They induce sleep by increasing activity of GABA, a neurotransmitter that lowers activity of the central nervous system. I’ve written at length about GABA and its role in sleep, here.

Medications containing eszopiclone, zaleplon, and zolpidem will now come with what’s known as a black box warning, alerting doctors to the presence of serious risks linked to these drugs. It’s called a black box warning because the risks will now be highlighted in a highly visible box on the drug label. Until now, these warnings were put in small print within the drug label. The FDA issues its strictest, most prominent warning when it has evidence of life-threatening risks associated with the drugs. To be clear, these risks can be rare, and still require a black box warning, alerting doctors to the need to consider these risks when evaluating a potential benefit for their patients.

What are the dangers linked to sleep medication? 

In the case of these three drugs used in medications to treat insomnia, the FDA’s decision to issue a black box warning is a result of dozens of reports (66 reports, over a period of 26 years) of serious injuries and death as a result of what they call “complex sleep behaviors” in people who have used these meds. They include:

·     accidental overdoses

·     falls

·     burns

·     near drowning and drowning

·     car accidents

·     hypothermia

·     carbon dioxide poisoning

·     self-injuries, including from gunshot wounds and apparent suicide attempts

In its initial announcement of the new warning for sleep medication, the FDA makes a point to note that these 66 cases are ones that either have been reported directly to the FDA or cited in scientific literature, and there may be more instances of which they’re not aware. Likely underreporting of hazardous events related to sleep medication use is one big reason why it’s difficult to tell exactly how rare these risks truly are.

What causes sleep driving and other dangerous sleep-related behaviors? 

Many of you have probably heard about cases of people being active—often behaving strangely—while taking sleep meds. Sleep eating, sleep driving, and sleep walking are a few of the most well-known so-called “complex behaviors” linked to sleep medications, behaviors that can put people in danger during sleep.

Scientists don’t yet fully understand how these meds may be causing this activity during sleep. But scientific evidence shows these sleep medications are linked to parasomnias, and specifically to altered states of arousal during sleep. During periods of sleep-based arousal, people can undertake all sorts of activity—cooking, driving, going outside—while still in a partial state of sleep. Most of the time, people who experience these parasomnias while taking sleep medication have no memory of what they did. (Most people in the reports the FDA cited in its new warning had no memory of their behavior.) During these episodes of sleep arousal, the sleep may seem to other people to be confused, or in a trance, not awake but in an altered state of mind. Their motor skills may be compromised, which can further put them at risk for injury. As the FDA warning notes, it is possible for people to commit acts of violence on themselves or others while taking these medications. I’ve written about the history and prevalence of sleep violencesleep forensics, and some of the most famous cases where the “sleepwalking defense” has been used.

As I’ve said, we’ve yet to grasp the full impact of these drugs on the brain and on consciousness during sleep. But we do know some important things that may point us to a better understanding of how prescription drugs for sleep contribute to these behaviors.

We know the brain remains active throughout sleep. In fact, mostareas of the brain are active during sleep. Consciousness isn’t something that switches off when we fall asleep. Rather, it takes on different forms. I like to think about the brain in sleep as a hybrid car: sometimes it runs on gas, and other times on electricity. That means during sleep, different states of consciousness can overlap. A state of mixed consciousness—where some parts of the brain are “sleeping” and others are “awake”—could lead to the ability to undertake complex activity without having full cognitive control, or memory of the events afterward. Because they work directly to alter brain activity, sleep medications may be altering mixed consciousness during sleep in ways that lead to dangerous behaviors. 

The risks linked to prescription sleep medications

The risk for dangerous behavior during sleep that is associated with sleep medications appears to be relatively rare. But it’s important for doctors and patients to be aware of these very serious risks. There are other short and long-term risks and side effects linked to prescription sleep drugs that are important to understand as well.

Side effects of prescription sleep medication 

Side effects will differ somewhat among prescription sedative-hypnotics, but most of these sleep medications share a group of side effects. In addition to the hazardous behaviors listed above, these sleep medication side effectsinclude:

·     Dizziness and lightheadedness (which can lead to accidents, including falls)

·     Headache

·     Nausea, diarrhea, and other gastrointestinal problems

·     Prolonged drowsiness that lasts into the morning (which can make it difficult and dangerous to drive)

·     Allergic reactions

·     Problems with memory and daytime performance

Potential for dependence.All three medications included in the FDA warning—eszopiclone, zaleplon, and zolpidem—can lead to people becoming dependent. Patients prescribed these sleep medications can develop a tolerance to their effects, which may lead to taking higher dosages than recommended or prescribed. Research of zolpidem and eszopiclone suggests that people with psychological conditions or substance use disorder may be at the highest risk for developing a dependence on these drugs.

Higher mortality risks.Studies show that using sedative hypnotic drugs is linked to a significantly greater risk of all-cause mortality. A 2018 review of research found that more than three dozen studies have identified a higher risk of death among people who use sedative-hypnotics. For example, a 2012 study found the risk of death was more 3 times higher in people who used fewer than 18 doses of sedative hypnotic sleep medication over the course of an entire year.

Higher risks for developing cancer and other diseases. Studies have linked the use of sedative-hypnotics to the development of cancer. One study found that among the highest users of these medications, a risk for developing cancerincreased by 35 percent, compared to people who didn’t take these drugs for sleep. Studies also show using sedative hypnotics is linked to more new cases of depression. That 2018 review of research found that combined, studies showed people using sedative hypnotics developed slightly more than twice the number of new cases of depressionas people not using these medications. These drugs are also linked to elevated risk for suicide. Research has also found these sleep medications linked to greater risk for developing—and dying from—infections, including pneumonia.

How well do prescription sleep medications work? 

Increasingly, scientific study is showing that these prescription drugs, while posing serious health risks, often deliver only minimal benefits at best for sleep. A large-scale analysis recently found that use of sedative-hypnotics delivers an average of only 11 additional minutes of sleep per night.

At the same time, studies show that non-drug therapies, in particular cognitive-behavioral therapy for insomnia, or CBT-I, work more effectively than prescription drugs to alleviate insomnia, improve sleep amounts and sleep quality, and protect daytime function and performance.

What to do if you’re taking these sleep medications

First: don’t panic. For most people who take them, sleep medications will not lead to these most serious side effects. Do talk with your physician about your medication use and the risks associated, including this new warning. Discuss alternative, non-drug therapies, including CBT-I, light therapy, and natural remedies for sleep disturbances, as well as the practices of strong sleep hygiene. If you and your physician determine the right choice is to stop using your sleep medication, set a tapering schedule to help you avoid short-term disruption to your sleep and any possible symptoms of withdrawal. Remember: You should never change your dosage without speaking to your doctor, even if you are lowering it.

For anyone who is taking sleep medications and experiences sleep behaviors while not fully awake, or finds they’ve undertaken behaviors during sleep that they don’t recall, the FDA instructs to contact your doctor right away

The message is pretty clear: while in some cases prescription sleep medication may be necessary, overall we’re safer, healthier, and we sleep better when we put our investments of time, effort, and money into non-drug remedies for sleep problems—remedies that address the underlying issues of our troubled sleep, and deliver strong, lasting, evidence-based improvements to our nightly rest.

Sweet Dreams,

Michael J. Breus, PhD, DABSM

The Sleep Doctor™


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Michael Breus, Ph.D - The Sleep Doctor is a Diplomate of the American Board of Sleep Medicine and a Fellow of The American Academy of Sleep Medicine and one of only 168 psychologists to pass the Sleep Medical Specialty Board without going to medical school. Dr. Breus is a sought after lecturer and his knowledge is shared daily in major national media worldwide including Today, Dr. Oz, Oprah, and for fourteen years as the sleep expert on WebMD. Dr. Breus is the bestselling author of The Power of When, The Sleep Doctor’s Diet Plan and Good Night!

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