The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's Zepbound® (tirzepatide) as the first prescription medication for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. This approval broadens Zepbound's indications beyond its 2023 use for obesity management, offering a novel therapeutic approach to addressing this sleep-related breathing disorder.

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”

The decision is based on results of the SURMOUNT-OSA trials, which demonstrated that Zepbound significantly reduced apnea-hypopnea events, a key measure of OSA severity, by up to 62.8% over 52 weeks. Nearly 50% of participants achieved remission or mild OSA, and substantial weight loss, up to 20% of body weight, was observed among participants using Zepbound, alone or in combination with positive airway pressure (PAP) therapy​.

OSA, often misunderstood as “just snoring,” is associated with serious health risks, including fatigue, excessive daytime sleepiness, and disrupted sleep. Zepbound provides a much-needed pharmacological option alongside lifestyle interventions and existing therapies like PAP.

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