For decades, the standard fix for obstructive sleep apnea has been a bedside pump and a mask strapped to the face.
Two Phase 3 trials published in the New England Journal of Medicine in June 2024 found that the weekly weight-loss injection tirzepatide, sold as Zepbound, cut breathing disruptions by up to 62.8 percent in adults who had moderate-to-severe sleep apnea and obesity.
That translated into roughly 25 to 30 fewer apnea or hypopnea events per hour of sleep on tirzepatide, versus about 5 per hour with placebo, according to the SURMOUNT-OSA program led by Atul Malhotra of the University of California San Diego.
The Food and Drug Administration approved Zepbound for moderate-to-severe obstructive sleep apnea in adults with obesity on December 20, 2024, making it the first prescription drug cleared for the condition.
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Obstructive sleep apnea, in which the upper airway repeatedly collapses during sleep, is estimated to affect tens of millions of American adults and remains widely undiagnosed despite loud snoring, daytime fatigue and other warning signs.
What the two trials actually showed
SURMOUNT-OSA ran as two parallel double-blind trials in adults with a body mass index of 30 or higher.
Trial 1 enrolled 234 people who were not using a positive airway pressure machine. Trial 2 enrolled 235 people who were already on PAP therapy but wanted more relief. Participants received tirzepatide at a maximum tolerated dose of 10 or 15 milligrams once a week, or matching placebo, for 52 weeks.
In the group not using a PAP machine, the apnea-hypopnea index fell by an average of 25.3 events per hour on tirzepatide, compared with 5.3 on placebo. In the group already on PAP therapy, it fell by 29.3 events per hour on the drug, versus 5.5 on placebo, the trial data show.
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By the end of the year, 43.0 percent of tirzepatide users in Trial 1 and 51.5 percent in Trial 2 met the criteria for disease resolution, meaning their apnea had shifted to mild or resolved altogether.
More than a weight-loss story
Tirzepatide belongs to a class of drugs that mimic the gut hormones GLP-1 and GIP, quieting appetite and food intake.
Participants lost roughly 17 to 20 percent of body weight on the drug, and researchers also recorded reductions in high-sensitivity C-reactive protein of 40 to 50 percent and drops in systolic blood pressure of 7.6 to 9.6 mmHg, pointing to broader cardiometabolic effects that go beyond fat loss around the throat.
That matters because sleep apnea itself is tied to a higher risk of heart disease, and even the standard CPAP treatment does not eliminate that risk in every patient. Welltica has previously reported on new evidence that CPAP may raise heart disease risk in a subset of users.
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Side effects, and who this is for
The Zepbound label carries the class-typical gastrointestinal warnings. In the trials, pooled rates of diarrhea reached 24.0 percent on tirzepatide versus 10.7 percent on placebo, and nausea reached 23.6 percent versus 7.7 percent. Acute pancreatitis occurred in 0.9 percent of tirzepatide users and none of the placebo group.
The FDA approval covers adults with moderate-to-severe obstructive sleep apnea who also have obesity, alongside a reduced-calorie diet and more physical activity, Eli Lilly said in its announcement. It is not approved for sleep apnea patients at a normal weight, and it does not replace a sleep study or a discussion with a physician about whether the drug is appropriate.
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This article is made and published by Mie Hermansen, who may have used AI in the preparation.