FDA Slaps New Boxed Warnings on Prescription Sleeping Pills

We all knew sleeping pills such as Lunesta, Ambien and Sonata were not without dangerous side effects. Though evidence in this regard has thus far been anecdotal, and often the butt of jokes, the FDA has finally made it all official.

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On April 30, 2019, the Food and Drug Administration has updated the mandatory warnings for medicines containing eszopiclone, zaleplon and zoldipem. That does indeed cover all the above mentioned brands and more.

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What determined the FDA to make this move?

Reports have been mounting concerning dangerous side effects sparked by medicines taken by millions of people world over to combat insomnia. Such side effects include, but are not limited to: sleepwalking, driving in a cognitively impaired state, using a stove while not fully awake etc.

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While some of these may seem funny, they are literally deadly-serious. The FDA’s Adverse Event Reporting System logged some 66 reports of events provoked by the mentioned substances, some of which resulted in serious injuries and others in deaths.

Of the 66 cases associated with zaleplon, zoldipem and eszopiclone use, 20 resulted in death. These included carbon monoxide poisoning, car crashes, cases of hypothermia, falls as well as drowning.

The 46 non-fatal injuries covered self-inflicted gunshot wounds, attempted suicide, hypothermia leading to near-death, burns, blunt trauma associated with falls, as well as near-drowning.

Though such events are obviously not common, they are prevalent enough to warrant the addition of the newly mandated warnings.

As an insomnia sufferer, who uses of sleep medicine, you probably have some questions, such as:

  1. Which drugs are affected by the new warning regime?
  2. Do the new rules affect dosage/efficiency in any way?
  3. Why did all this come to light now? Zoldipem has been available for more than 20 years…
  4. What are complex sleep-related behaviors? Can doctors prescribe these sleeping pills to those who experienced such behaviors?
  5. Is there anything patients can do to alleviate next-morning mental impairment?

Eszopiclone is present in Lunesta, Zaleplon in Sonata, while zoldipem is used in Ambien, Edluar, Ambien CR, Zolpimist and Intermezzo. Obviously, other brands containing these components present the same dangers as the mentioned ones. Of these, extended-release drugs are the riskiest. Next-morning mental impairment results from zolpidem concentrations still present in the organism.

Women have a harder time eliminating the active substance than men, so they are at an increased risk.


As far as dosage goes, the FDA has contacted manufacturers in a bid to convince them to reduce the zoldipem doses of the mentioned products.

For women, the recommended dosage has been lowered from 10 mg to 5 mg for immediate release products. For extended-release versions such as Ambien CR, a drop from 12.5 mg to 6.5 mg has been floated.

The FDA would like to see the same dosage reduction for men.

The recommendations concerning dosage revision are only valid for zoldipem-containing products. For now, no such limitations are likely to be implemented for other sleeping pills.

Why now?

It essentially took the FDA this long to cobble together the relevant data. Sleeping pill-induced complex sleep behaviors are not easy to track. The causality of these behaviors is difficult to establish as well.

The FDA has been monitoring these substances since it approved them.

Complex sleep-related behaviors? What are they?

Sleep walking and driving while half awake are complex sleep-related behaviors.

If they fail to eliminate the active substances of sleeping pills from their systems before they wake up, patients will be at risk of such behavior. The tricky part is that one can experience an impaired mental alertness state, without even realizing it.

According to the FDA, health care professionals should not prescribe sleeping pills to patients with a history of complex sleep-related behavior. Also, patients should be verbally warned about the rare but possible serious side effects these medicines may produce.

What can you do to combat these side effects?

When it comes to sleeping pills, dosage is of the essence. It is extremely important that you should take exactly the prescribed dose. The only proper way to use such medicines is to take the minimum required dose to treat your insomnia. Anything above that is not only overkill, it can be extremely dangerous.

Do not self-dose sleeping pills. What you reckon is needed to treat your symptoms is most likely way off the mark. You need the active substances eliminated from your body before you wake up. Otherwise you will experience impaired mental alertness.

Bear in mind that the FDA has received more reports than the above mentioned 66 that involved serious injuries or death.

More than 700 such reports were logged by the Adverse Event Reporting system concerning impaired driving abilities. These reports were deemed serious enough to prompt label changes on zoldipem-based products back in 2007.

New information has then been added to the warnings and precautions section. The measures raised a media frenzy, which in turn resulted in more such reports being submitted to the FDA.

While they did raise awareness, these reports failed to provide scientifically relevant information. More precisely, they mostly did not include any information on dosage, on the time of the accident, on other cognition-impairing substances taken, or on actual zoldipem blood levels. That explains why it took the FDA this long to determine the likely causes of these sleeping pill side effects.

Do you run the same risks with other insomnia medications?

The jury is still out on that. The FDA is in the process of collecting data on other medicines. It would not be a surprise if side effects similar to the zoldipem-linked ones were found in other sleeping pills too.


Do not, under any circumstances, treat your sleeping pills lightly. Do not overdose on them, even if you feel the prescribed dose fails to address your insomnia. The active substance in these medicines is extremely potent and it can indeed produce life-threatening side effects.

If possible at all, try to have your insomnia treated through alternative methods.

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