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FDA approves Zepbound for sleep apnea

It’s the first medication that reduces symptom severity, reducing breathing interruptions at night
Jennifer Larson writer headshot
By | Jan. 2, 2025 Medically reviewed by Karen Berger, Pharm.D.
Zepbound obstructive sleep apnea - FDA stamp

Key takeaways

  • The U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide) as the first medication for the treatment of obstructive sleep apnea.

  • The approval expands the potential uses for Zepbound, which was first approved for chronic weight management in November 2023.

  • The medication helps improve obstructive sleep apnea symptoms by helping people lose weight, which is a major risk factor for this disorder.

In this article:

The U.S. Food and Drug Administration (FDA) recently approved Zepbound (tirzepatide) as the first prescription drug for obstructive sleep apnea. Zepbound was first approved for chronic weight management in November 2023 and will now be available to help adults with obesity who have moderate to severe obstructive sleep apnea, along with exercise and a reduced-calorie diet. 

What is obstructive sleep apnea?

Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder, according to the Mayo Clinic. OSA occurs when the muscles supporting the airway relax, causing the airway to become partially or even completely blocked, making it difficult for enough air to flow through. Without a steady stream of air, blood oxygen levels drop, which triggers a reflex in your brain to wake you up just enough to breathe again. It can happen over and over in the middle of the night, disrupting your sleep and making you feel tired and sluggish the next day. It can also cause other symptoms, such as headaches, mood changes, and difficulty concentrating. While anyone can develop OSA, it is more common in people who are obese. 

RELATED: Who should get a sleep apnea test?

How does Zepbound help with sleep apnea?

Research shows that Zepbound improves obstructive sleep apnea by reducing body weight. Zepbound belongs to a category of drugs known as dual GIP/GLP-1 receptor agonists. These drugs work by activating receptors from certain hormones secreted from the intestines, thus reducing appetite. Zepbound slows the movement of food through the digestive tract, which makes people feel full more quickly. 

According to manufacturer Eli Lilly and Company, the drug was evaluated in clinical trials for the treatment of moderate-to-severe OSA in adults with obesity over the course of one year. Some participants also used positive airway pressure (PAP) therapy during the trial, while others did not. 

The results of the SURMOUNT-OSA phase 3 clinical trials found that Zepbound was approximately five times more effective than a placebo (inactive treatment) in reducing breathing disruptions in adults who were not using PAP therapy. Those patients experienced 25 fewer episodes of disrupted breathing per hour, compared with five fewer episodes with a placebo. Meanwhile, the patients who were on PAP therapy experienced 29 fewer breathing disruptions per hour while taking Zepbound, compared with six fewer with placebo.

Additionally, 50% of the adults on both Zepbound and PAP therapy experienced either remission or mild, non-symptomatic OSA and lost an average of 20% (50 pounds) of their body weight. Also, adults on Zepbound alone experienced improved OSA symptoms and lost an average of 18% (45 pounds) of their body weight. 

Expanding sleep apnea treatment options

According to experts, obstructive sleep apnea affects approximately 15% to 30% of males and 10% to 15% of females in North America. However, the actual numbers may be even higher, since it often goes undiagnosed. 

“Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA in a statement. “Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. 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.”

Although the approval does expand treatment options, Zepbound may not be appropriate for everyone with obstructive sleep apnea and obesity. According to the manufacturer’s medication guide, people who have a personal or family history of medullary thyroid carcinoma, which is a type of thyroid cancer, or an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), should not use Zepbound. 

However, they may be able to use the existing treatment options for OSA, which include:

  • Oral appliances
  • Breathing devices, such as continuous positive airway pressure (CPAP), auto-adjusting positive airway pressure (APAP), and bilevel positive airway pressure (BiPAP) machines.
  • Lifestyle changes, such as smoking cessation
  • Changes in sleep position
  • Surgery 

Will insurance cover Zepbound for sleep apnea?

It’s likely that insurance will cover Zepbound for sleep apnea. However, they may require that patients try other treatment methods first, such as CPAP machines before covering this prescription. Contact your insurance provider to check your coverage.

Does Medicare cover Zepbound for sleep apnea?

Medicare did not previously cover Zepbound because it does not pay for obesity treatments. However, it will likely cover GLP-1s that treat other conditions, such as sleep apnea.

How much does Zepbound cost?

There is no generic version of Zepbound available in the U.S. If your insurance does not cover the medication, the average price for a month’s supply ranges from $1,200 to $1,500. 

However, there are ways to save on Zepbound. You can use SingleCare to get discounts on Zepbound at your participating pharmacy. 

Zepbound coupons

When will Zepbound be available?

Because this drug was already approved to treat obesity, it is available at pharmacies across the U.S. today.