Friday, October 3, 2025

FDA Approves Eli Lilly’s Zepbound for Sleep Apnea

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FDA Approves Zepbound for Treating Patients with Obstructive Sleep Apnea

The Food and Drug Administration (FDA) has approved Eli Lilly’s blockbuster weight loss drug Zepbound for treating patients with the most common sleep-related breathing disorder, obstructive sleep apnea (OSA). This new approval expands the use of Zepbound and could pave the way for Eli Lilly to gain broader insurance coverage for the treatment.

What is Zepbound?

Zepbound is a weekly injection that is now the first drug treatment option cleared for patients with obesity and moderate-to-severe OSA. It should be used in combination with a reduced-calorie diet and increased physical activity, according to the FDA.

Prevalence of OSA

An estimated 80 million patients in the U.S. experience OSA, with approximately 20 million having moderate-to-severe forms of the disease. However, 85% of cases go undiagnosed, according to Eli Lilly.

Patient Perspective

"Too often, OSA is brushed off as ‘just snoring’ – but it’s far more than that," said Julie Flygare, president and CEO of Project Sleep, a nonprofit advocating for sleep health and sleep disorders. "It’s important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes."

Market Impact

Eli Lilly expects to launch Zepbound for OSA at the beginning of next year. This approval is the first beyond obesity treatment for Zepbound, which entered the market late last year and is also being tested for several other obesity-related conditions, such as fatty liver disease.

Conclusion

The FDA’s decision could pave the way for Eli Lilly to gain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not typically covered by many insurance plans. This approval also backs up mounting evidence that there could be further health benefits tied to GLP-1s, a class of weight loss and diabetes treatments that have soared in popularity and slipped into shortages over the past year.

FAQs

Q: What is Zepbound?
A: Zepbound is a weekly injection that is now the first drug treatment option cleared for patients with obesity and moderate-to-severe OSA.

Q: How does Zepbound work?
A: Zepbound should be used in combination with a reduced-calorie diet and increased physical activity.

Q: How many people experience OSA?
A: An estimated 80 million patients in the U.S. experience OSA, with approximately 20 million having moderate-to-severe forms of the disease.

Q: What are the symptoms of OSA?
A: OSA can lead to loud snoring and excessive daytime sleepiness, and can contribute to serious complications including stroke and heart failure.

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