The U.S. Food and Drug Administration (FDA) has approved Zepbound, a prescription weight-loss medication, as the first drug specifically for treating moderate to severe obstructive sleep apnea (OSA) in people with obesity.
This groundbreaking approval marks a new approach to managing a condition that affects up to 30 million Americans and often goes undiagnosed.
OSA is characterized by repeated interruptions in breathing during sleep, caused by blocked airways. Left untreated, it can lead to serious health issues such as heart disease, stroke, and diabetes.
While weight loss has long been recognized as an effective way to reduce the severity of OSA, Zepbound now provides an additional treatment option for patients struggling with obesity-related sleep apnea.
Zepbound is part of the GLP-1 receptor agonist class of drugs, which includes popular medications like Ozempic. Manufactured by Eli Lilly, the drug is intended to be used alongside a reduced-calorie diet and increased physical activity.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Dr. Sally Seymour, director of the FDA’s Division of Pulmonology, Allergy, and Critical Care.
In clinical trials, Zepbound demonstrated impressive results. Nearly half of the participants using the medication experienced such significant improvements in their OSA symptoms that they were no longer classified as having the condition.
The approval was based on two major trials, which were conducted by Eli Lilly and published in the New England Journal of Medicine. These studies included nearly 470 participants, some of whom were already using continuous positive airway pressure (CPAP) machines, the standard treatment for OSA.
The researchers measured OSA severity using the apnea-hypopnea index (AHI), which tracks the frequency of breathing interruptions during sleep.
In the trial with participants not using CPAP, Zepbound reduced AHI events by an average of 25 interruptions per hour over a year, compared to just five interruptions in the placebo group. Among CPAP users, the drug reduced events by 29 per hour, compared to six with the placebo.
In addition to improving sleep apnea symptoms, participants taking Zepbound experienced significant weight loss—18% to 20% of their body weight (about 45 to 50 pounds) on average over the course of a year. This far exceeded the 1.6% to 2.3% weight loss seen in the placebo group.
Zepbound was first approved in November 2023 for weight management, but this new indication offers hope for patients with obesity and OSA. It may also help patients with OSA gain access to the drug through Medicare, which doesn’t cover medications solely for weight loss.
Eli Lilly has emphasized efforts to make the drug accessible through patient support programs, including a lower-cost vial option. However, the monthly cost of Zepbound without insurance remains high, exceeding $1,000.
“Many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” said Patrik Jonsson, president of Lilly Cardiometabolic Health.
With Zepbound’s approval, patients now have a new treatment option that addresses both the root cause—obesity—and the debilitating symptoms of obstructive sleep apnea.
If you care about sleep, please read studies about herb that could help you sleep well at night, and these drugs could lower severity of sleep apnea by one third.
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The research findings can be found in Circulation: Genomic and Precision Medicine.
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