Averaging up to 20% of weight loss, adults taking Zepbound had at least 25 fewer breathing interruptions each hour as they slept, and, after one year, up to 50% no longer had symptoms associated with OSA.

RT’s Three Key Takeaways:

  1. FDA Approval: The FDA has approved Zepbound (tirzepatide) as the first prescription medication for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity.
  2. OSA Symptom Relief: Zepbound reduced breathing interruptions by an average of 25-29 events per hour, with up to 50% of patients experiencing remission or mild OSA symptoms after one year.
  3. Weight Loss Outcomes: Patients on Zepbound lost an average of 18-20% of their body weight, equivalent to 45-50 pounds, highlighting its dual benefit for improving OSA symptoms and addressing obesity.

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

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,” says Julie Flygare, JD, president and CEO of Project Sleep, in a release. “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.” 

Clinical Trial Results

This approval was based on results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated Zepbound (10 mg or 15 mg) 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. 

Zepbound was about five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy, leading to 25 fewer breathing disruptions per hour with Zepbound and five with placebo. 

[RELATED: Eli Lilly’s Mounjaro Doesn’t Need Separate Approval for Sleep Apnea, Says EMA]

In adults on PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared to six with placebo. After one year, 42% of adults on Zepbound and 50% of adults on Zepbound with PAP therapy experienced remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.

In addition to improved OSA symptoms, 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 lbs (20%) of their body weight, compared to four pounds (2%) and six pounds (2%) on placebo, respectively.

“Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” says Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA, in a release. “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.”

This is the second indication in the US for Zepbound in just over a year, following the FDA approval for adults with obesity or overweight who also have weight-related medical problems in November 2023. 

ID 296792907 © Oleschwander | Dreamstime.com