FDA Boxed Warning for Ambien

Figure 1: FDA Boxed Warning for Ambien. The FDA has placed a Boxed Warning for Ambien, Sonata, and Lunesta. These sleep medications have caused 66 known cases of serious injury or death from "Complex Sleep Behaviors." Among these cases are 20 deaths and 46 injurites. Most were taking Ambien at the time.

Ambien, Sonata, and Lunesta are some of the most commonly prescribed medications in the United States. There are 38 million prescriptions for drugs containing zolpidem, also known as Ambien.

These medications are very safe for the majority of people, with relatively few side effects.

However, on occasion, they can cause what scientists call "Complex Sleep Behaviors." If you've ever heard of someone driving or sleep walking while on Ambien, they are experiencing a complex sleep behavior.

These behaviors include sleep walking, sleep eating, and sleep driving. While rare, they can on occasion cause serious injury or death. The FDA has confirmed 20 deaths and 46 serious injuries from Ambien, Lunesta, and Sonata.

Source:FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

FDA Boxed Warnings

The FDA, which regulates medications in the United States, also regulates how drugs are labelled. In drugs that have particularly dangerous side effects, the FDA can require a boxed warning, otherwise known as a black box warning. These warnings are meant to indicate that the drug has been shown to have serious or life-threatening side effects. Common drugs that carry "boxed warnings" include antidepressants that can increase suicide rates and Ambien, which can cause injury from Complex Sleep Behaviors.

Most Common Injuries on Ambien

Figure 2: Most Common Injuries on Ambien. Falls are the most common injury and cause of death on Ambien, accounting for 22 known serious injuries and 6 known deaths. There have been 5 attempted suicides and 4 completed suicides on Ambien. 7 people have injuried themselves. 5 have accidently overdosed. 5 have been injured from hypothermia.

Of the people who were injured or killed while on Ambien, most were because of falls. Sleep walking is relatively common. When you're "not totally there," it can be easy to injury yourself. Ambien has also been believed to be responsible for several cases of attempted and completed suicides, as well as multiple self injuries.

5 people were injured on Ambien through hypothermia, presumably when they went outside while still under the influence of Ambien.

How Does Ambien Work

Ambien and other similar drugs are hypnotic drugs. They act on GABA, a neurotransmitter responsible for decreasing activity in the brain. Ambien is supposed to help people fall asleep faster, stay asleep longer, and keeps them from waking up in the middle of the night. This same mechanism can lead to complex sleep behaviors.

Source: FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

Staying Safe while on Ambien

Figure 3: Staying Safe while on Ambien. Stop taking Ambien if you've experienced Sleep Walking, Sleep Eating, Sleep Driving, or other similar activities while not fully awake. Only take as much and as often as prescribed by your doctor. Don’t take with alcohol. Don’t use Ambien for naps.

This label is not intended to keep people from taking Ambien, rather it's to warn and advise patients on how to stay safe while taking this effective drug.

If you have experienced any sleep walking, sleep eating, or other complex sleep behaviors, stop taking Ambien and talk to your doctor.

Otherwise, be sure to only take as much and as often as you're prescribed for. Don't take Ambien or any sleep medications with alcohol. Alcohol has similar mechanisms to these drugs and can interfere with how your body responds to the medication.

Finally, don't take Ambien unless you plan on sleeping the whole night. If you have to wake up in a few hours, for example with a nap, these drugs can cause sleepiness and grogginess after you wake up early.

Source: FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines

Related: Valerian Root

Valerian Root is a great natural alternative to ambien. Unlike many other herbal remedies, valerian root has been studied in multiple scientific trials.

Valerian Root is an herb used by the Ancient Greeks for sleep. Some placebo-controlled trials have shown valerian to be effective. For the most part, Valerian is very safe, with few known side effects.

Related: Blue Light

One way to improve sleep without medications is by reducing your exposure to blue light before bed.

Late night phone and computer use have been clearly linked to worse sleep. Our device screens suppress our body's natural sleep signals. Blue light filtering has emerged as a possible solution to get our sleep back on track.

Key Takeaways

If you have experienced a "complex sleep behavior," stop taking your medication and talk to your doctor.

As the FDA writes, this can be very dangerous to your health:

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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. These 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. As a result, we are requiring a Boxed Warning, our most prominent warning, to be added to the prescribing information and the patient Medication Guides for these medicines. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem.