Many people struggling with apnea will now have a new way to help them sleep more soundly. This month, the Food and Drug Administration expanded the approval of Eli Lilly’s obesity drug Zepbound to explicitly cover sleep apnea as well.
On Friday, the FDA officially approved Zepbound as a treatment for moderate to severe obstructive sleep apnea in adults with obesity. In two large-scale clinical trials, the drug successfully helped people lose weight and reduced their apnea symptoms. Zepbound is now the first ever prescription drug approved for obstructive sleep apnea, a condition that affects around 12% of Americans.
Apnea happens when our bodies temporarily stop breathing during sleep, which causes the brain to wake the person just enough to start breathing again, only for the cycle to restart once the person falls back asleep. The more severe a person’s apnea, the more these episodes of stopped or reduced breathing occur in a night (though not always associated with apnea, snoring is a sign of having narrow airways while sleeping). Obstructive sleep apnea, or OSA, is caused by the physical blockage of airway muscles and is the most common form by apnea by far.
While there are several risk factors for OSA, obesity is known to be an especially major contributor to it. The active ingredient in Zepbound, tirzepatide, has proven to be highly effective at treating obesity, with people losing upwards of 20% body weight in trials. So Eli Lilly wanted to test whether the drug could effectively treat apnea as well.
Across both trials, tirzepatide did as well as expected in outperforming a placebo. People lost between 18% and 20% of their body weight. On average, the drug also reduced the frequency of apnea episodes by up to two thirds, with participants experiencing about 30 fewer episodes a hour. And up to 50% of people taking tirzepatide were free of any symptoms after one year.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, in a statement announcing the FDA’s approval. “This is a major step forward for patients with obstructive sleep apnea.”
There are already other highly effective treatments for apnea, most notably continuous positive airway pressure (CPAP) machines. So CPAP will remain a gold standard option for many, particularly for those with apnea who aren’t obese. But CPAP machines do require daily use at night, which can be too cumbersome for some people to tolerate over the long term. By contrast, the weekly injection needed to take Zepbound might be much more convenient for some eligible patients. In the clinical trials, people taking both Zepbound and CPAP saw even better outcomes than any other group—highlighting the potential benefits of combination therapy.
Zepbound and similar GLP-1 drugs aren’t entirely hassle-free, though. Their most common side-effects include vomiting, diarrhea, and other gastrointestinal symptoms. These drugs also aren’t cheap, with list prices hovering over $1,000 a month. But the expanded approval should make it easier for some people to secure insurance coverage of Zepbound, and simply having more interventions available for apnea is invaluable. So as with obesity, this approval could very well open up a new era for sleep apnea treatment.
