On December 20, 2024, the FDA approved tirzepatide (Zepbound) for moderate-to-severe obstructive sleep apnea in adults with obesity — the first pharmacologic therapy ever approved for OSA.
The approval was based on the SURMOUNT-OSA program, two parallel 52-week phase-3 trials (one with concurrent PAP therapy, one without). Across both trials, tirzepatide reduced the apnea-hypopnea index by approximately 25–29 events per hour relative to placebo, with 40–50% of treated participants achieving an AHI below the 5 events/hour clinical-remission threshold.
The mechanism is believed to be primarily mediated through reduction of upper-airway adiposity secondary to weight loss, though a direct effect on respiratory drive cannot be excluded. For patients intolerant of positive-airway-pressure therapy, the approval opens a meaningful new pathway. Coverage and prior-authorization frameworks for this specific indication remain in flux through most of 2025–2026.