Tirzapatide approved by FDA as first sleep apnea medication

On Dec. 20. 2024, Eli Lilly announced the FDA has approved Zepbound (tirzepatide) as the first and only prescription medication for adults with moderate-to-severe obstructive sleep apnea and obesity. Read the FDA press release announcing Zepbound’s approval for sleep apnea. The American Academy of Sleep Medicine also issued a statement for patients and clinicians about Zepbound for sleep apnea.

The FDA approval is based on results of the SURMOUNT-OSA phase 3 clinical trials, a global, multi-center study comparing Zepbound to placebo in adults with moderate-to-severe OSA and obesity. Randomizing 469 participants, the trial evaluated changes in apnea-hypopnea index over 52 weeks, including both those using and not using positive airway pressure therapy. Participants received either Zepbound (10 mg or 15 mg) or placebo.

Results show that Zepbound reduced breathing disruptions by 25–29 per hour versus 5–6 with placebo and achieved sleep apnea remission/mild cases in 42% (non-PAP) and 50% (PAP) of participants, compared to 16% and 14% with placebo after one year.

Additionally, adults on Zepbound lost 18–20% of body weight (45–50 lbs), compared with 2% (4–6 lbs) with placebo, with greater weight loss seen in those using PAP therapy.