The FDA has announced new (and stronger) warning requirements for certain prescription insomnia medications. Here's why.
Insomnia is an insidious little devil. Whether it prevents one from falling asleep initially or if it sneaks in during the wee hours of the night, it is a condition that affects around one-third of American adults. We write about sleep – and lack thereof – frequently on TreeHugger because good sleep in one of the basics of good preventative medicine. Not getting enough sleep is linked to many chronic diseases and conditions, like type 2 diabetes, heart disease, obesity, and depression.
Because insomnia is so prevalent in modern life (for the Victorians it wasn't a problem because they devised the perfect workaround), Americans are expected to spend $52 billion on sleep aids and remedies by 2020.Not only is this costly, but the cumulative effect simply isn't sustainable when one factors in the pollution and resources that go into producing the medications, packaging them, shipping them, and the waste that then ends up in the landfill.
And then there's the really dark side, as evidenced by a new warning issued by the U.S. Food and Drug Administration.
According to a statement from the agency, they are requiring a new boxed warning – their most prominent warning – on these prescription insomnia drugs: Eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist). From the statement:
The boxed warning follows several reports of rare, but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. These complex sleep behaviors may include sleepwalking, sleep driving and engaging in other activities while not fully awake, such as unsafely using a stove.
“We recognize that millions of Americans suffer from insomnia and rely on these drugs to help them sleep better at night. While these incidents are rare, they are serious and it’s important that patients and health care professionals are aware of the risk. These incidents can occur after the first dose of these sleep medicines or after a longer period of treatment, and can occur in patients without any history of these behaviors and even at the lowest recommended doses,” said FDA Acting Commissioner Ned Sharpless, M.D.
“Today’s action is an important step in our ongoing effort to call more attention to these critical safety issues and serves as an example of our ongoing commitment to ensuring that patients and health care professionals have the information they need to make informed treatment decisions," he added.
The FDA explained that they have been keeping their eye on the safety profiles of these medication ever since they were approved. When monitoring indicated the risk of more serious injuries and deaths from people who experienced complex sleep behaviors while taking the drugs, they decided the public needed more information. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said, “We’ll continue to monitor and evaluate these risks associated with insomnia medications and communicate with the public or consider further actions, as appropriate.”
Leading to the new warning was a review of 66 cases reported to the FDA Adverse Event Reporting System or found in medical literature, in which patients taking these three drugs became engaged in activities while they were not fully awake.
Forty-six of the cases led to serious but non-fatal injuries caused by accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds and apparent suicide attempts, according the the FDA statement.
The other 20 cases ended in death; the causes of which were carbon monoxide poisoning, drowning, fatal falls, hypothermia, fatal motor vehicle collisions with the patient driving, and apparent suicide.
You can see the entire FDA statement here; I encourage anyone taking, or considering these medications to read it. In the meantime, we're kind of in a pickle. Getting enough sleep is crucial for good health, but if getting enough sleep means (in rare cases) that you might end up driving or swimming while asleep, well, that's not such a great outcome either.
WIth that in mind, we're back to TreeHugger turf: See related stories below for sleep-encouraging lifestyle changes, good sleep hygiene, natural remedies, and more...