FDA Approves Tirzepatide for Obstructive Sleep Apnea in Obesity

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved tirzepatide (Zepbound) as the first and only prescription treatment for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.¹

Announced by Eli Lilly and Company on December 20, 2024, adults with OSA receiving tirzepatide achieved an average of up to 20% weight loss while experiencing ≥25 fewer breathing interruptions for each hour slept.

“Too often, OSA is brushed off as ‘just snoring’ – but it’s far more than that. It is important to understand OSA symptoms and know that treatments are available, including new options like [tirzepatide],” Julie Flygare, JD, president and chief executive officer of Project Sleep, said in a statement.¹ “We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.”

OSA is a breathing disorder during sleep, marked by the partial or complete collapse of the upper airway.² This collapse can result in apnea, hypopnea, drops in oxygen levels, and/or brief awakenings from sleep. While snoring is a classic sign of OSA, other prominent symptoms include fatigue, excessive daytime sleepiness, and fragmented sleep, which can make the condition easy to miss.

Tirzepatide was initially FDA-approved in November 2023 for the treatment of adults with obesity or overweight who also experience weight-related medical problems, based on positive results from the SURMOUNT-1 and SURMOUNT-2 trials.³ It is the first and only dual-activating glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) agonist for obesity, tackling an underlying cause of excess weight.

Regulators have now awarded approval to tirzepatide for moderate-to-severe OSA and obesity based on positive data from the Phase 3 SURMOUNT-OSA clinical trial.¹ The trial assessed tirzepatide 10 mg or 15 mg in 469 adults with OSA and obesity irrespective of positive airway pressure (PAP) therapy over 52 weeks.⁴

Among patients not on PAP therapy, tirzepatide was approximately 5 times more effective than placebo in reducing breathing disruptions, achieving 25 fewer hourly breathing disruptions compared with 5 for the placebo cohort. For those on PAP therapy, tirzepatide demonstrated 29 fewer hourly breathing disruptions compared with 6 for placebo.

At the 1-year mark, approximately 42% of adults treated with tirzepatide and 50% of those on tirzepatide plus PAP therapy experienced remission or mild, non-symptomatic OSA. The respective percentages for the placebo-treated cohorts were 16% and 14%, respectively.

Adults treated with tirzepatide also saw an average reduction of 18% body weight (~45 lbs), while those on tirzepatide plus PAP therapy lost an average of 20% body weight (~50 lbs), compared with 2% (~4 lbs) and 2% (~6 lbs) on placebo, respectively.

Safety data reported in SURMOUNT-OSA suggested the observed safety profile was similar to the profile reported in the SURMOUNT and SURPASS trials. The most common events related to tirzepatide were gastrointestinal-related and considered mild to moderate in severity.

In the release, Eli Lilly indicated tirzepatide should be used with a reduced-calorie diet and increased physical activity to assist adults with moderate-to-severe OSA and obesity in improving their sleep disorder.

“[Tirzepatide] is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity,” Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA, said in a statement.¹ “Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges.”

References

1. _{FDA approves Zepbound® (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. Eli Lilly and Company. December 20, 2024. Accessed December 20, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription.}
2. _{Slowik JM, Sankari A, Collen JF. Obstructive Sleep Apnea. [Updated 2024 Mar 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459252/}
3. _{Campbell P. FDA approves Tirzepatide (Zepbound) for Chronic Weight Management. HCP Live. November 8, 2023. Accessed December 20, 2024. https://www.hcplive.com/view/fda-approves-tirzepatide-zepbound-chronic-weight-management.}
4. _{Campbell P. Tirzepatide shows benefit in obstructive sleep apnea, surmount-osa trial. HCP Live. April 17, 2024. Accessed December 20, 2024. https://www.hcplive.com/view/tirzepatide-shows-benefit-in-obstructive-sleep-apnea-surmount-osa-trial.}