What All Women Should Know About the FDA's Latest Warnings About Sleep Medication

For many of us, it’s almost instinctual to reach for the Ambien when you really need to get eight hours of sleep to prepare or a big day. But a new warning from the FDA might make you think twice about relying on sleeping medications.

Yesterday the FDA announced that it will now require the packaging of some sleep medications to feature warnings about potential dangerous side effects.

The administration is requiring the packaging of some of these medicines to feature a boxed warning stating the potential dangerous side effects. A statement from the FDA says the boxed warning is the “most prominent warning” a drug can have.

The statement comes after the FDA learned of “rare but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines.” Some of these behaviors were reported to the FDA, and some were stated in medical literature.

Among what the administration refers to as these “complex sleep behaviors” are sleepwalking, driving while sleeping, and engaging in other unsafe activities–such as using a stove–while asleep. The packaging warnings will be required for eszopiclone, zolpidem, and zaleplon. Some brand name versions of those drugs are Lunesta, Sonata, Edluar, Ambien, Ambien CR, Intermezzo, and Zolpimist.

The FDA analyzed the cases of 66 individuals who took an insomnia medication and ended up dead or with a serious injury. Forty-six of those cases involved non-fatal injuries. Among these were accidental overdoses, burns, falls, near-drowning incidents, gunshot wounds, apparent suicide attempts, and the loss of a limb or a near-death experience resulting from exposure to cold temperatures. The remaining 20 cases resulted in deaths caused by  “carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving, and apparent suicide,” the statement says.

Harneet Walia, MD, who works at the sleep disorders center at Cleveland Clinic, can attest to the fact that these medications do cause what the FDA is calling “complex sleeping behaviors.” She’s observed these behaviors in her patients who take sleep medications and agrees with the FDA’s decision to more clearly label the drugs as potentially dangerous. “It’s the right thing to do to enhance the warning related to these medications so patients and health care professionals have this information,” she tells Health. “It’s probably good to be aware of these warnings. Based on [the FDA’s] data, there were some serious injuries.” 

Dr. Walia explains that some of the medications called out by the FDA are more harmful to women than men—a point that isn’t mentioned in the FDA’s new statement.

She explains that women process zolpidem differently than men, which means they should be prescribed lower doses of the medication. Common brand names of zolpidem include Edluar, Ambien, Ambien CR, Intermezzo, and Zolpimist. “In 2013, [the] FDA had come up with [a] lower dose recommendation for women, particularly for zolpidem. That didn’t necessarily happen. Higher prevalence of this unsafe zolpidem dose continued,” Dr. Walia explains. She says that even though the administration warned the public of the risks of a higher zolpidem dose prescribed to women in 2013, two years later 68% of women who took zolpidem reported taking more than the recommended dose of the drug. While Dr. Walia spoke of this problem, she emphasized that sleep medications are incredibly common, and specialized experts aren’t always the ones prescribing them. In fact, sleep medications are often prescribed by primary care doctors, who might not be as knowledgeable about them.

If falling asleep at night is becoming more and more difficult, it might be worth your while to see a doctor who specializes in sleep disorders. Chances are, they’ll be better suited to prescribe you the right sleeping pill—and the right amount of it—if you should need one.

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