Zepbound receives FDA approval to treat sleep apnea

The Food and Drug Administration (FDA) approved the obesity medication on December 20 Zepbound (tirzepatide) as the initial pharmaceutical treatment for moderate to severe cases obstructive sleep apnea (OSA) in adults with obesity.

Obesity is a major risk factor for OSA, a condition characterized by disturbed breathing during sleep due to blockages in the airways. This can cause symptoms such as snoring and daytime sleepiness, as well as an increased risk of cardiovascular disease, diabetes and mental illness in the long term.

About 17% of people in the United States have moderate or severe OSA, and the condition is more common in older adults and people who are obese.

The approval marks a second indication for Zepbound, which is approved for the treatment of overweight and obesity and uses the same active ingredient as the type 2 diabetes drug. Mounjaro.

“Too often, OSA is dismissed as ‘just snoring’ – but it is much more than that,” said Julie Flygare, JD, president and CEO of Project Sleep, in a press release from drug manufacturer Eli Lilly. “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 providers and ultimately lead to better health outcomes.”

Lilly’s filing with the FDA this year was supported by data from two Phase 3 clinical trials. Zepbound was approximately five times more effective than placebo at reducing breathing disruptions during sleep. Nearly half of the participants saw such significant improvement that they no longer had symptoms associated with OSA.

The first drug against obstructive sleep apnea

Zepbound is the first drug approved for OSA. The current gold standard for OSA treatment is positive airway pressure (PAP). Continuous PAP, or CPAPMachines help open the airways and significantly reduce the number of sleep disruptions the average patient experiences per night.

In a Lilly study, participants using PAP therapy had about 25 fewer sleep disruptions within an hour when using Zepbound, compared to five fewer sleep disruptions in the placebo group.

In another study, people taking Zepbound without PAP therapy had about 28 fewer sleep disruptions per hour, compared to about five fewer events in the placebo group.

After one year, up to half of adults taking Zepbound no longer had symptoms related to OSA.

“That’s pretty good and robust data,” Jorge Moreno, MDan internist at Yale Medicine who is board-certified in obesity medicine and was not involved in the Lilly study, Verywell told me.

Many people may not be able to use a CPAP machine due to discomfort, irritation, and concerns about how it will affect their appearance or interactions with bed partners. Moreno said he expects Zepbound could be used in addition to PAP or as an alternative for people who are uncomfortable using a sleep machine.

“I have patients who cannot tolerate the CPAP machine at all. They fight it all night, they take it off and they don’t use it as much as they should,” Moreno said. “Those patients can try Zepbound and see if that helps with treatment compliance.”

Access and affordability of Zepbound

Clinical guidelines from the American Academy of Sleep, last updated in 2006, noted that anti-obesity medications can be effective stand-alone treatments for OSA, but some patients may need to use other interventions in addition to weight management.

However, Moreno said a patient’s ability to use Zepbound continuously depends on how reliable their access to the drug is. The FDA this week removed Zepbound from its drug shortage list for the first time since its approval last year. However, some worry that this measure could impact people who rely on cheaper generic versions of the drug. When a drug is removed from the shortage list, compounding pharmacies are no longer allowed to mix off-brand versions for people who do not have access to the brand-name drug.

It is not yet clear whether health insurers will reimburse the costs of Zepbound for people with OSA. Many health insurers plan to increase the personal contribution or suspend coverage GLP-1 drugs by 2025. Insurers may also require patients to try other treatments before reimbursing Zepbound for OSA.

The OSA indication is the latest in a series of approvals for the use of blockbuster obesity drugs to treat comorbid health conditions. This year, the FDA granted an indication to Wegovy, Novo Nordisk’s obesity drug, to treat heart failure. Lilly is also seeking an FDA indication for Zepbound to treat heart failure, and the company is testing its use in the treatment liver disease And substance use disorder.

How Zepbound can fit into OSA treatment

In the Lilly studies, participants took the highest dose of Zepbound they could tolerate: 10 milligrams or 15 milligrams. They also received nutritional and lifestyle guidance.

Moreno said the minority of his patients who take a GLP-1 drug are taking the maximum dose of the drug. Most patients take a moderate dose of the drug so that they can compensate for their weight loss with side effects.

“The people who are most successful with their weight loss in the long term are the individuals who take on all the pieces of the puzzle: they take medications, they change dietary habits and they are active,” Moreno said.

If pharmacological treatment is right for you, there are other options. In addition to the CPAP, there are several PAP machines that can help you regulate your breathing at night. Dental appliances, such as mandibular advancement devices and tongue retainers, can also provide some relief.

More intensive treatments include surgery to remove excess tissue from the upper airway and bariatric surgery for long-term weight management.

What this means for you

If you continually wake up feeling restless or feel sleepy during the day, talk to your healthcare provider about getting treatment sleep test for OSA. Getting a diagnosis can improve your ability to treat OSA and prevent related long-term health problems such as heart disease, diabetes, and mental health problems.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts in our articles. To learn more about how we fact-check and keep our content accurate, trustworthy and reliable, read our editorial process.

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By means of Claire Bugos

Bugos is a senior news reporter at Verywell Health. She received a bachelor’s degree in journalism from Northwestern University.

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