Life-Threatening Risks Prompt FDA to Order “Black Box” Warning Labels for Ambien and Other Sleep Aids

Sleep medications like Ambien have long been controversial and have been linked to bizarre behavior in users.

On Tuesday, the Food and Drug Administration (FDA) announced that it is requiring manufacturers of Ambien and other sleep medications to add a Boxed Warning – the agency’s most prominent warning – to the prescribing information and the patient Medication Guides for these drugs.

Often referred to as a “black box warning”, the label is the strictest alert placed on prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug. As the name indicates, it is a warning with a black box around it. Having the black box around the warning means that an adverse reaction to the drug may lead to death or serious injury.

Prescription sleep medications carry terrifying risks.

The agency is warning the public that rare but serious injuries and deaths have been linked to the use of certain common prescription insomnia drugs. Dangerous behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep, according to the FDA’s Safety Announcement.

Sleepwalking, sleep driving, and engaging in other activities while not fully awake (like using the stove) are among the risks associated with the medications, the agency explains:

We identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death. This number includes only reports submitted to FDA or those found in the medical literature, so there may be additional cases about which we are unaware.

These cases included accidental overdoses, falls, burns, near drowning, exposure to extreme cold temperatures leading to loss of limb, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions with the patient driving, and self-injuries such as gunshot wounds and apparent suicide attempts. Patients usually did not remember these events. The underlying mechanisms by which these insomnia medicines cause complex sleep behaviors are not completely understood. (source)

In addition to the boxed warning, the agency is requiring the inclusion of a contraindication that states these medications should not be used by people who have experienced an episode of complex sleep behaviors after taking them. The link between these drugs and complex sleep behaviors is already included on labels, which have been updated continually to note additional safety issues as they were identified.

“The boxed warning and contraindication are intended to make the warning more prominent and reflect the risk of serious injury and death,” the FDA clarifies.

If you take sleeping pills, here’s what the FDA wants you to know.

The agency offers the following guidelines and warnings for patients:

As a requirement of their approval, insomnia medicines must be dispensed with a patient medication guide that explains the medicine’s uses and risks. Patients should review this information each time they receive a refill of their medicine as information may change. Health care professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have a history of complex sleep behavior after taking these insomnia medicines. Patients should be advised that rare, but serious injuries and death are possible. Patients should discontinue taking these medicines and contact their health care professional right away if they find themselves to have engaged in activities while not fully awake or if they do not remember activities done while taking the medicine.

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 drug labels 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 decreased mental alertness the morning after use even if they feel fully awake. (source)

“Prescriptions for sleeping pills grew to more than 20 million in 2010 from 5.3 million in 1999, according to national estimates. About one in eight people with sleeping difficulty report using the drugs; among people of retirement age, more than a third report taking a sleeping aid,” reports The New York Times.

Sleep medications carry additional risks.

While the serious and potentially fatal risks outlined above are troubling, they aren’t the only problems associated with sleep medications.

According to the Cleveland Clinic, other possible side effects include oversleeping, being too drowsy to drive or perform other tasks the following day, allergic reactions, and facial swelling.

Long-term use of sleeping pills can lead to dependence and addiction. Overuse can cause serious health consequences, including memory problems, mental and behavioral disorders, learning problems, and worse insomnia (beyond the initial baseline) once use has stopped.

Inadequate sleep is a serious public health problem.

A study published in the journal Sleep found that inadequate sleep is a public health problem affecting more than one in three adults worldwide and that insufficient sleep could also have serious economic consequences.

According to the article Six (More) Reasons to Get Better Quality Sleep, insufficient sleep is associated with:

• lapses in attention and the inability to stay focused
• reduced motivation
• compromised problem solving
• confusion, irritability and memory lapses
• impaired communication
• slowed or faulty information processing and judgment
• diminished reaction times
• indifference and loss of empathy
• increased risk of heart attacks, stroke, hypertension, obesity, diabetes, and depression

How much sleep you need depends on several factors, including your age, lifestyle, and overall health. The general recommendation for people age 18 and over is 7-9 hours of sleep per night.

Yet, polls and surveys show that 20-30% of us get less than 6 hours of sleep per night.

Keep in mind that sleep quality is even more important than quantity, so even if you are sleeping for 7-9 hours per night, but you toss and turn for much of that time, you might be sleep-deprived.

According to the National Sleep Foundation, there are questions you can ask yourself to help you determine if the quantity and quality of your sleep are sufficient:

Are you productive, healthy and happy on seven hours of sleep? Or does it take you nine hours of quality ZZZs to get you into high gear? Do you have health issues such as being overweight? Are you at risk for any disease? Are you experiencing sleep problems? Do you depend on caffeine to get you through the day? Do you feel sleepy when driving?

If you are among the sleep-deprived, there’s drug-free hope.

If you are one of the millions of people who just aren’t getting enough Zzzs, there are things you can do to naturally improve the quality and quantity of your sleep. These tips from Ready Nutrition may help.

• Establish consistent sleep and wake times – even on the weekends
• Set a bedtime that is early enough for you to get at least 7 hours of sleep
• Don’t go to bed unless you are sleepy
• Create a comfortable and inviting sleep environment – your bedroom should be calming, cool (65 degrees is optimal but no warmer than 75 degrees), and dark
• Create a relaxing bedtime routine – turn off electronic devices, take a bath or read a book (not IN bed), or listen to soothing music
• Avoid using your computer or watching TV while in bed – turn off electronic devices at least 30 minutes before bedtime
• Limit exposure to bright light in the evenings
• Finish eating 2-3 hours before you go to bed
• Reduce your fluid intake before bedtime
• Exercise regularly (but not for a few hours before bed – it may keep you awake if done too close to bedtime)
• Avoid caffeine too close to bedtime

Here are some additional tips from our article The Vicious Cycle of Sleep Deprivation During Stressful Nights:

• Drink some chamomile tea. It will help you relax.
• Craft something with your hands. From my experience, that is an excellent way to free the mind and prepare the body for a peaceful sleep.
• Simple breathing exercises perform wonders for our body and brain. You could also try yoga and meditation techniques, especially if you can do them in nature. I’m no expert, but when I need to relax before bed, I close my eyes and think of beautiful memories from my life or imagine a peaceful place where I feel safe and serene.

CBD also may help you stop tossing and turning, as we explained in Can’t Sleep? Got Insomnia? These Studies Suggest CBD for Sleep Disorders:

A growing body of research suggests CBD has powerful anti-anxiety properties and antidepressant-like effects and may reduce inflammation and pain, so if any of those things are interfering with your sleep, CBD may help.

A 2017 research review reported that studies on cannabis and insomnia suggest that “CBD may have therapeutic potential for the treatment of insomnia”, and that it “may hold promise for REM sleep behavior disorder and excessive daytime sleepiness.”

Other studies have found that CBD may increase overall sleep amounts. It has been shown to reduce insomnia in people who suffer from chronic pain. In smaller doses, CBD stimulates alertness and reduces daytime sleepiness, which is important for daytime performance and for the strength and consistency of the sleep-wake cycle.

A study published in 2018 investigated the effects of CBD and other cannabis compounds on insomnia. Researchers collected data from more than 400 volunteers using a digital app, which allowed them to analyze the effects of CBD and other cannabinoids in people’s natural sleep environments. They found CBD significantly reduced insomnia symptoms. (source)

What do you think?

Do you experience sleep difficulty? Are there any tips or tricks that work for you? Please share your thoughts and ideas in the comments.

About the Author

Dagny Taggart is the pseudonym of an experienced journalist who needs to maintain anonymity to keep her job in the public eye. Dagny is non-partisan and aims to expose the half-truths, misrepresentations, and blatant lies of the MSM.