Obstructive sleep apnea (OSA) affects approximately one billion people worldwide, with 60 to 70 percent of patients also living with obesity. For decades, treatment options were limited to mechanical devices like CPAP machines. This has changed: tirzepatide (brand name Zepbound) has become the first medication approved by the U.S. Food and Drug Administration (FDA) for moderate-to-severe OSA in adults with obesity. The approval is based on the Phase 3 SURMOUNT-OSA trial.
What does the SURMOUNT-OSA trial show?
The multicenter, randomized, double-blind trial evaluated tirzepatide (10 mg or 15 mg weekly) over 52 weeks in 469 participants across two arms: patients not using CPAP therapy (Study 1) and those on CPAP (Study 2). The results are striking:
- Study 1 (no CPAP): Tirzepatide reduced the apnea-hypopnea index (AHI) by a mean of 27.4 events per hour vs. 5.0 with placebo - a relative reduction of approximately 63 percent.
- Study 2 (with CPAP): Tirzepatide lowered AHI by 29.3 events per hour (placebo: 5.5).
- Disease remission: After 52 weeks, 42 percent (Study 1) and 50 percent (Study 2) of tirzepatide-treated patients achieved remission or only mild OSA.
The findings were published in the New England Journal of Medicine (Malhotra et al., 2024) and presented at the American Diabetes Association's 84th Scientific Sessions.
FDA approval and EMA position
The FDA granted approval in December 2024 - the first pharmacological treatment option for OSA ever. The agency emphasized that tirzepatide should be used alongside a reduced-calorie diet and increased physical activity. The European Medicines Agency (EMA), however, saw no need for a separate label extension, as tirzepatide's existing weight management indication (Mounjaro) already covers OSA patients with obesity. The SURMOUNT-OSA data were nonetheless added to the prescribing information.
Clinical significance
This approval marks a paradigm shift: for the first time, a medication directly targets the underlying obesity and significantly reduces OSA severity. Experts like Dr. Louis Aronne (Weill Cornell Medicine) consider the combination of tirzepatide with CPAP the optimal strategy for OSA patients with obesity. For more details on mechanism and evidence, visit our tirzepatide page.
Important: Tirzepatide is a prescription medication. The SURMOUNT-OSA trial shows that not all patients respond equally - follow-up sleep studies are recommended. Also read our article on retatrutide, the next candidate in the GLP-1 class.
Disclaimer: This article is for informational purposes only and does not constitute medical advice. If you suspect sleep apnea or are considering tirzepatide treatment, please consult a healthcare professional.