FDA Approves Zepbound for Obese Adults with Sleep Apnea

The FDA has approved Eli Lilly’s Zepbound (tirzepatide) as the first and only prescription drug approved to treat obese adults with moderate to severe obstructive sleep apnea, according to a recent news release.

Obstructive sleep apnea is a serious condition in which a patient stops breathing while asleep, caused when the soft tissue in the back of the throat collapse, according to the American Academy of Sleep Medicine. Breathing pauses typically last between 10 and 30 seconds, but in severe cases, they may exceed one minute and can occur hundreds of times a night. This can lead to a sudden drop in blood oxygen saturation, excessive daytime sleepiness and impaired concentration. Overweight and obese patients are more at risk because of excess pharyngeal fat in the neck, which obstructs airflow during sleep.

This approval is based on the results of the SURMOUNT-OSA phase 3 clinical trial which evaluated Zepbound’s effect on sleep apnea symptoms of over the course of a year, using the change in apnea-hypopnea index (AHI) as a primary measure. Researchers found that Zepbound was most effective when used in combination with positive airway pressure (PAP) therapy, which delivers pressurized air through a mask worn while sleeping. This combination resulted in 26 fewer breathing disruptions per hour, compared to 25 fewer in patients treated with just Zepbound and six fewer disruptions in patients taking placebo.

In addition to improved sleep, patients taking Zepbound lost an average of 18% of their body weight —about 45 pounds— during the trial, compared to about 2% overall bodyweight loss (about 4 pounds) in the placebo group.

"Too often, [obstructive sleep apnea] is brushed off as 'just snoring' — but it's far more than that," Julie Flygare, J.D., president and CEO of sleep health non-profit, Project Sleep, said in the news release. "It's important to understand [obstructive sleep apnea] 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."

This is the second indication for Zepbound. In November 2023, it was approved to treat overweight or obese adults with weight-related medical problems cardiovascular disease and diabetes.

The current list price of Zepbound is $1,059.87 per fill. Patients may pay as little as $25 for a one- to three- month supply, depending on insurance status and eligibility.