FDA approves weight loss drug Zepbound to treat sleep apnea: NPR

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

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The weight loss drug Zepbound has become the first prescription drug approved for the treatment of 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 in which a person struggles to breathe properly during sleep. The federal agency recommends that the drug be used in combination with a low-calorie diet and increased exercise.

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

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

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

This was true for both participants who used a CPAP machine and those who did not.

“This is a major step forward for patients with obstructive sleep apnea,” said Dr. Sally Seymour, director of the Pulmonary, Allergy and Critical Care Division of 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 biggest 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 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 tirzepatid, was approved by the FDA in November 2023 for the treatment of obesity – becoming a new competitor to Novo Nordisk’s blockbuster Wegovy.

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