Zepbound approved by FDA as first sleep apnea medication

On Dec. 20, 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.

About Zepbound

Zepbound is an injectable prescription medication that targets GIP and GLP-1 hormones to regulate appetite and metabolism. By reducing hunger and food intake, it addresses an underlying cause of excess weight.

The medication may improve moderate-to-severe OSA and aid in long-term weight loss for adults with obesity or overweight with related health issues when combined with a reduced-calorie diet and increased physical activity.

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.

In November 2023, Zepbound received FDA approval to treat adults with obesity or overweight who also have weight-related medical problems.

About sleep apnea

Obstructive sleep apnea is a prevalent and serious sleep disorder that involves the airway becoming repeatedly blocked during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health problems such as high blood pressure, heart disease, stroke, diabetes and depression.

Read more industry news from the AASM.

Updated Jan. 9, 2025