FDA approves Zepbound: First prescription medication for obstructive sleep apnea in adults

UPDATED: Dec 21, 2024 21:50 IST

The US Food and Drug Administration (FDA) has approved the first prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA): the weight-loss drug Zepbound.

Zepbound may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. Drugmaker Eli Lilly said in a news release that it should be used in conjunction with a reduced-calorie diet and increased physical activity.

“This is a major step forward for patients with obstructive sleep apnea,” Dr. Sally Seymour, director of the FDA’s Division of Pulmonology, Allergy, and Critical Care, said in the FDA announcement.

"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."

OSA affects as many as 30 million people in the US and is closely associated with obesity, according to the American Academy of Sleep Medicine. OSA is a sleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep, which can lead to pauses in breathing (apnea) or shallow breathing (hypopnea) and a potential decrease in oxygen saturation and/or waking from sleep. One of the hallmarks of OSA is snoring, but fatigue, excessive daytime sleepiness and disrupted sleep are also key symptoms, making this serious condition easily overlooked.

"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. "Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity."

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 obese adults 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.

According to the company press release, Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if it is safe and effective for use in children. Zepbound may cause tumours in the thyroid, including thyroid cancer.

Zepbound can cause side effects such as nausea, diarrhoea, vomiting, constipation, abdominal (stomach) discomfort and pain, injection site reactions, fatigue, hypersensitivity (allergic) reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease.