The Food and Drug Administration has approved the use of Zepbound in adults with obesity and moderate to severe obstructive sleep apnea.

Getty Images/iStockphoto

Hide caption

Toggle label

Getty Images/iStockphoto

The weight loss medication Zepbound is the first prescription medication approved to treat obstructive sleep apnea.

The Food and Drug Administration on Friday approved the use of Zepbound, made by Eli Lilly & Co., for adults with obesity and moderate to severe obstructive sleep apnea (OSA), a common condition in which a person has difficulty sleeping properly to breathe. The federal authority recommends taking the drug in combination with a reduced-calorie diet and increased exercise.

Sleep apnea occurs when a person’s upper airway is blocked. Although it can affect anyone, it is more common in people who are overweight.

The FDA said studies have shown that Zepbound contributes to weight loss by supporting weight loss Sleep apnea symptoms in some patients.

In two studies of adults who had obesity and moderate-to-severe OSA over a 52-week period, participants who received Zepbound experienced a “statistically significant and clinically meaningful reduction” of Episodes of shallow breathing or temporary pauses in breathing during sleep received a placebo, the FDA said.

This applied to both participants who used a CPAP machine and those who did not use a CPAP machine.

“This is a major advance for patients with obstructive sleep apnea,” said Dr. Sally Seymour, director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, in a statement.

The American Academy of Sleep Medicine (AASM) said it supports FDA approval of Zepbound for the treatment of sleep apnea, but emphasized that it is not an option for everyone.

“Although obesity is the main predisposing factor for sleep apnea, many cases of sleep apnea are related to other factors such as the structure of the jaw and upper airway,” the group said in a statement on Saturday.

The AASM said patients taking Zepbound should know that sustained weight loss is required for it to be effective for sleep apnea symptoms.

The FDA approval comes amid growing debate about the potential uses of weight-loss drugs beyond treating obesity and diabetes. In addition to sleep apnea, there is increasing interest in exploring its potential to treat addiction and certain types of cancer.

Although this class of drugs, so-called GLP-1 agonists, was developed two decades ago, research into their possible uses is still in its early stages.

Zepbound, commonly known as tirzepatide, was approved by the FDA for the treatment of obesity in November 2023, making it a new competitor to Novo Nordisk’s blockbuster Wegovy.

Last March, the FDA approved Wegovy to reduce the risk of strokes, heart attacks and other cardiovascular problems in obese patients.