FDA Approves Obesity Drug Zepbound To Treat Sleep Apnea

Eli Lilly and Company has announced that the U.S. Food and Drug Administration has approved Zepbound as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.

A press release states, “Zepbound may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a reduced-calorie diet and increased physical activity.”

“Too often, OSA is brushed off as ‘just snoring’ — but it’s far more than that,” said Julie Flygare, J.D. President and CEO of Project Sleep. “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.” 

OSA is a sleep disorder that occurs when the upper airway fully or partially collapses during sleep, according to the release. This leads to pauses in breathing, which are categorized as apnea, or shallow breathing, which is a disorder called hypopnea. It can also cause a decrease in oxygen saturation and lead to waking from sleep. Those who have the disorder are characterized by symptoms of fatigue, excessive daytime sleepiness, and disrupted sleep.

“Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” said Patrik Jonsson, EVP and president of Lilly Cardiometabolic Health and Lilly USA. “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.”

How Does Zepbound Work To Treat Sleep Apnea?

The FDA has cleared Eli Lilly’s obesity drug Zepbound as the first treatment for obstructive sleep apnea in the U.S. https://t.co/7zzdT48pIc

— STAT (@statnews) December 20, 2024

Eli Lilly and Company revealed that the approval to use this obesity-treatment drug for sleep apnea was based on results from SURMOUNT-OSA phase 3 clinical trials. These trials evaluated the drug “for the treatment of moderate-to-severe OSA in adults with obesity, with and without positive airway pressure (PAP) therapy over the course of a year.”

According to the company, the drug proved to be approximately five times more effective than a placebo in decreasing breathing disruptions in adults not using PAP therapy, resulting in 25 fewer disruptions per hour compared to five with the placebo.

The testing results were also promising for adults on PAP therapy. In this case, Zepbound led to 29 fewer breathing disruptions per hour compared to six with the use of a placebo. Patients who used Zepbound to treat sleep apnea for one year found that they experienced remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.

In addition, adults on Zepbound lost an average of 45 pounds — 18% of their body weight — while adults on Zepbound with PAP therapy lost an average of 50 pounds — 20% of their body weight — compared to 4 pounds (2%) and 6 pounds (2%) on placebo. This is the second FDA approval for Zepbound in just over one year, following its use to treat adults with obesity or who have weight-related medical problems.

Zepbound is an injectable prescription medicine. It should be used with a reduced-calorie diet and increased physical activity.