FDA approves Zepbound as first ever prescription drug to treat sleep apnea with obesity

The U.S. Food and Drug Administration (FDA) approved tirzepatide (Zepbound) on Dec. 20, making it the first and only prescription medication indicated for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity, according to an announcement from Eli Lilly and Company.

“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.”

Zepbound was approved by the FDA in November 2023 for adults with obesity or overweight who also have weight-related medical problems.

The latest approval was backed by data from a phase 3 trial that studied two groups of adults with moderate-to-severe OSA and obesity — those who were unable or unwilling to use positive airway pressure (PAP) therapy and those who were continuing on PAP therapy. Eli Lilly said in the news release that tirzepatide delivered improvements in OSA symptoms while also promoting significant weight loss.

Obstructive sleep apnea, marked by pauses in breathing during sleep, is often underdiagnosed and can lead to serious health issues such as daytime sleepiness and cardiovascular problems. The new therapy offers an additional treatment option for physicians managing patients with this common and serious disorder.

“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, in the release. “It’s important to understand OSA symptoms and know that treatments are available, including new options like Zepbound.”