FDA approves weight loss drug Zepbound to treat obstructive sleep apnea

The weight loss drug Zepbound has become the first prescription medication approved to treat obstructive sleep apnea.

The Food and Drug Administration on Friday authorized the use of Zepbound, made by Eli Lilly & Co., for adults with obesity and moderate to severe obstructive sleep apnea (OSA), a common condition where a person struggles to breathe properly during sleep. The federal agency advises that the drug is used in combination with a reduced-calorie diet and increased exercise.

Sleep apnea occurs when a person's upper airway becomes blocked. While it can affect anyone, it is more prevalent among those who are overweight.

The FDA said studies have shown that by aiding weight loss, Zepbound helps reduce sleep apnea symptoms in some patients.

In two studies with 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" in episodes of shallow breathing or temporary pauses in breathing while asleep compared to those who received a placebo, the FDA said.

That was true for both participants who used a CPAP machine and those who do not.

"This is a major step forward 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 the FDA's approval of Zepbound as a sleep apnea treatment but emphasized that it is not an option for everyone.

"Although excess body weight is the major 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 on Zepbound should know that sustained weight loss is required for it to be effective against sleep apnea symptoms.

The FDA approval comes amid growing discussion about the potential uses of weight loss drugs beyond treating obesity and diabetes. In addition to sleep apnea, there has been increasing interest in exploring their potential to treat addiction and certain cancers.

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

Zepbound, generically known as tirzepatide, was approved by the FDA in November 2023 to treat obesity — becoming a new competitor to Novo Nordisk's blockbuster Wegovy.

Last March, the FDA approved Wegovy to be used to reduce the risk of strokes, heart attacks, and other cardiovascular problems in patients who are overweight.