FDA approves weight loss drug Zepbound to treat obstructive sleep apnea

December 21, 20241:06 PM ET

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Juliana Kim

Photo of a man sleeping while wearing a CPAP mask.

The Food and Drug Administration has authorized 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 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.

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

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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 federal approval does not come as a complete surprise, as doctors have long recommended that maintaining a healthy weight is crucial for preventing or easing sleep apnea symptoms.

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It comes amid growing discussions 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.

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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.

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