On December 20, 2024, Eli Lilly announced that the presecription medicine tirzepatide (Zepbound®) was approved by the U.S. Food and Drug Administration (FDA) as the first and only prescription medicine for adult obese patients living with moderate to severe obstructive sleep apnea (OSA). 

​

The Alliance of Sleep Apnea Partners CEO Monica Mallampalli, PhD, has issued the following statement:

​

“We applaud Eli Lilly’s latest success with tirzepatide, paving the way for the first-ever pharmaceutical treatment for OSA in obese patients. ASAP supports the concept of the right treatment for the right patients. Having access to multiple treatment options that work effectively for patients, whether used as standalone therapy or in combination with other therapies, is the first step to personalized care.”

​

On December 10, 2024, the Centers for Medicare & Medicaid Services (CMS) published a new proposed rule for 2026 to expand Medicare and Medicaid coverage of anti-obesity medications. Under this proposed rule, CMS would expand its coverage, broadening access to millions of individuals struggling with challenges associated with obesity and obstructive sleep apnea. 

​

ASAP supports the proposed expansion of coverage and encourages sleep apnea patients to submit a public comment by January 27, 2025, here.

​

More information on the CMS proposed rule can be found here (pages 99375 and 99518). 

 

Obesity is the strongest risk factor for obstructive sleep apnea for both males and females. OSA may cause weight gain, and weight gain may cause OSA, leading to a vicious cycle that can worsen patients’ health, impair their cognition, put them at higher risk of accidental injury through daytime sleepiness, and reduce their overall quality of life.

​

Research has shown that weight loss can reduce the severity of OSA symptoms and related cardiometabolic abnormalities that are associated with both OSA and obesity. But weight loss is not always the only factor in OSA, and patients who are not overweight can develop or continue to have sleep apnea. It’s important for sleep apnea patients to work with their healthcare providers to determine the best therapy or combination of therapies for them.

​

The FDA approval was based on the results of the SURMOUNT-OSA phase 3 clinical trial reported in April 2024 by Eli Lilly. Tirzepatide was administered to adults living with moderate to severe OSA and obesity, with and without positive airway pressure (PAP) therapy, for a year and was significantly effective in reducing the apnea-hypopnea index (AHI) compared to a placebo. Eli Lilly also reported a 20% reduction in body weight. Currently, AHI is used as a marker to evaluate the severity of OSA and how well a particular treatment works. It is worth noting that 70% of participants in these trials were males who previously had shown resistance to weight loss with this type of therapy. Reported side effects were considered mild to moderate in severity. 

​

It is important for patients considering this drug to consult their doctor to discuss appropriate treatment, lifestyle changes, and potential side effects.

​

Tirzepatide is a combination of two gut hormones called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) receptor agonist. Tirzepatide previously had been shown to significantly improve insulin sensitivity and reduce body weight. On November 8, 2023, tirzepatide injection was approved by the FDA for the treatment for chronic weight management and was commercialized in the U.S. as Zepbound®. The latest approval for OSA treatment is the second indication for Zepbound®. It has also previously been approved under the trade name Mounjaro® to be used to improve blood glucose levels in adults with type-2 diabetes. 

​

For more information and resources on sleep apnea, including symptoms and risk factors, visit the Alliance of Sleep Apnea Partners website at apneapartners.org.

​

About the Alliance of Sleep Apnea Partners

ASAP is a patient-led, U.S.-based 501c3 organization committed to promoting and advocating for the diagnosis, treatment, and management of sleep apnea on behalf of the patient community for optimal health of those suffering from sleep apnea. Learn more at apneapartners.org.