FDA Approves First Medication for Obstructive Sleep Apnea

Zepbound (tirzepatide) is already in widespread use as a treatment for obesity.
three zepbound 2.5 ml vials in a row
Zepbound is less expensive when sold in vials instead of auto-injection pens.Eli Lilly
The U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide) as the first prescription medication for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity, providing a new option for people managing both breathing issues during sleep and excess weight.

“This is the first drug treatment for obstructive sleep apnea, and so that’s exciting, and it provides a good opportunity to help the care of many people with obstructive sleep apnea and obesity,” says Atul Malhotra, MD, a professor of medicine and sleep medicine specialist at UC San Diego Health. Dr. Malhotra was the lead author of the clinical trials used for the approval of Zepbound.

The American Academy of Sleep Medicine (AASM) issued a statement that the approval “is a positive development for patients and clinicians, who now have another treatment option for this sleep disorder.”

How Does Zepbound Work?

The GLP-1 receptor agonist Zepbound fights obesity by mimicking two metabolic hormones in the body that stimulate insulin secretion and sensitivity after a person eats. The drug regulates the body’s blood sugar levels, slows down digestion and reduces appetite, which makes a person feel fuller, eat less, and lose weight.

Previous studies have found that the obesity drug (marketed as Mounjaro for type 2 diabetes) also leads to significant improvements in cholesterol, blood sugar, and blood pressure.

Although it’s not completely known how Zepbound improves obstructive sleep apnea (OSA), it’s likely related to weight loss, because obesity is a factor that increases the risk of OSA, says?Nathan Walker, MD, assistant professor of sleep medicine and memory and cognitive disorders, and program director of the Sleep Medicine Fellowship at the University of North Carolina in Chapel Hill.

“That’s through many mechanisms. For one, obesity causes direct compression of the upper airway with weight around the neck,” he says.

Another factor is that abdominal obesity reduces the functional capacity of the lungs, which then reduces lung inflation. “That reduces traction on the upper airway, making the upper airway more likely to collapse in sleep,” says Dr. Walker.

However, there are other mechanisms not related to obesity that cause OSA, he adds. Many cases of sleep apnea are related to other factors such as the structure of the jaw and upper airway.

Zepbound Effective in Reducing the Severity of OSA

The approval of Zepbound for obstructive sleep apnea treatment is based on the results of two major studies from the SURMOUNT-OSA clinical trials, which enrolled a total of 469 adults with moderate-to-severe OSA and obesity. Participants were randomly assigned to receive either Zepbound (at 10 or 15 milligram doses) or a placebo once a week for 52 weeks.

In the first trial, none of the participants received continuous positive airway pressure (CPAP) therapy (the standard treatment for OSA), and in the second trial, only people using CPAP therapy were included.

In both trials, people taking either dose of Zepbound experienced a significant reduction in the number of apneas and hypopneas per hour, as measured by the apnea-hypopnea index (AHI).

Apneas are periods when a person stops breathing and hypopneas are instances where airflow is blocked which causes shallow breathing.

Other key findings included:

  • Fifty percent of people on Zepbound with CPAP therapy and 42 percent of those using Zepbound without CPAP showed complete remission or a reduction to mild OSA, compared with just 14 percent and 16 percent in the placebo groups, respectively.
  • Participants in the Zepbound groups achieved a significant decrease in body weight, with an average weight loss of 45 pounds (18 percent) compared with 4 pounds (2 percent) for those on placebo.

Because people who didn’t have obesity weren’t included in the trial, it’s unclear if Zepbound would help with sleep apnea in people who don’t have obesity.

This question has not been tested in clinical trials. It would not be recommended to use GLP-1s outside the indications approved by the FDA,” says Ali El Solh, MD, MPH, a professor of medicine at the State University of New York in Buffalo, and supervisor of the sleep clinic at the VA Western New York Healthcare System.

Dr. El Solh was the lead author of a recent review on the use of GLP-1s on obesity-related obstructive sleep apnea.

What Does the Approval Mean for CPAP Therapy?

In the studies on tirzepatide and obstructive sleep apnea, patients had a roughly 50 percent reduction in the severity of their OSA on average, says Walker.

“On average, this would significantly reduce the severity of their OSA, but not necessarily eliminate it. So patients should not throw out their CPAP machines just yet,” he says.

Malhotra agrees that CPAP is still first-line treatment. “But it’s always been the case that we want to treat both sleep apnea and obesity,” he says.

Diet and exercise are still recommended, but Zepbound and other GLP-1 medications are more effective in helping people lose weight, says Malhotra.

“I think it’s important that people understand this approval doesn’t mean it’s the end of CPAP,” he adds.

Safety and Side Effects of Zepbound

Diarrhea, nausea, vomiting, and constipation were the most common side effects experienced by people taking Zepbound and were generally mild to moderate.

Side effects of Zepbound in clinical trials for obesity and type 2 diabetes also include fatigue, allergic reactions (typically fever and rash), burping, hair loss, and gastroesophageal reflux disease.

Zepbound causes thyroid C-cell tumors in rats, but it’s not known whether Zepbound causes those types of cancers in humans. Zepbound should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2, a rare inherited disorder that causes tumors in the endocrine glands and organs.

“These drugs are considered relatively new agents and thus the long-term safety of these medications is yet to be established,” says El Solh.

Cost and Insurance Coverage May Remain a Barrier for Many People

Although Zepbound and other GLP-1 receptor agonist medications are “game changers” because of their benefits for obesity, sleep apnea, and cardiovascular risk factors, these drugs often remain outside the reach of people who need them the most because of their cost, says El Solh.

Insurance coverage for Zepbound for OSA isn’t yet known. How much a person can expect to pay depends on what type of insurance they have.

The list price is $1,059.87 per 28-day supply for self-injecting pens.?Zepbound is only sold in vials in the 2.5 and 5 milligram doses, for $399 and $549 per month, respectively, through the manufacturer's LillyDirect program.

EDITORIAL SOURCES
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Resources
  1. FDA Approves First Medication for Obstructive Sleep Apnea. U.S. Food and Drug Administration. December 20, 2024.
  2. Malhotra A et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. The New England Journal of Medicine. June 21, 2024.
  3. Zepbound Approval for Sleep Apnea: American Academy of Sleep Medicine Statement. American Academy of Sleep Medicine. December 23, 2024.
  4. Cho YK et al. The Cardiovascular Effect of Tirzepatide: A Glucagon-Like Peptide-1 and Glucose-Dependent Insulinotropic Polypeptide Dual Agonist. Journal of Lipids and Atherosclerosis. July 19, 2023.
  5. El Solh AA et al. Current Perspectives on the Use of GLP-1 Receptor Agonists in Obesity-Related Obstructive Sleep Apnea: A Narrative Review. Expert Opinion on Pharmacotherapy. December 6, 2024.
  6. How Much Should I Expect to Pay for Zepbound (Tirzepatide). Lilly.
Becky Upham, MA

Becky Upham

Author

Becky Upham has been professionally involved in health and wellness for almost 20 years. She's been a race director, a recruiter for Team in Training for the Leukemia & Lymphoma Society, a salesperson for a major pharmaceutical company, a blogger for Moogfest, a communications manager for Mission Health, a fitness instructor, and a health coach.

She majored in English at the University of North Carolina and has a master's in English writing from Hollins University.

Upham enjoys teaching cycling classes, running, reading fiction, and making playlists.

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