The Food and Drug Administration (FDA) recently approved tirzepatide, sold under the brand name Zepbound, for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This approval marks a significant milestone, as Zepbound becomes the first medication authorized to treat this sleep disorder. The FDA’s announcement, made in a December 20 press release, also recommends that individuals using this medication incorporate calorie reduction and increased physical activity into their lifestyle.
Obstructive sleep apnea, a condition affecting millions, occurs when the upper airway becomes blocked during sleep, leading to pauses in breathing. These interruptions can disrupt sleep quality and have serious long-term health consequences. Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, emphasized the importance of this approval, calling it a “major step forward for patients with obstructive sleep apnea.”
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The FDA’s decision was based on the findings of two comprehensive 52-week studies involving obese adults with moderate to severe sleep apnea. These studies demonstrated that Zepbound, compared to a placebo, resulted in a “statistically significant and clinically meaningful reduction” in episodes of shallow breathing or temporary pauses in breathing, known as apneas. Notably, this positive effect was observed in both participants who used a Continuous Positive Airway Pressure (CPAP) machine and those who did not.
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While the American Academy of Sleep Medicine (AASM) supports the FDA’s authorization of Zepbound for sleep apnea, they caution that it is not a universal solution. The AASM underscores that while obesity is a primary risk factor for sleep apnea, other factors like jaw and upper airway structure can also contribute to the condition. Furthermore, the AASM emphasizes that sustained weight loss is crucial for the long-term effectiveness of Zepbound in treating sleep apnea symptoms.
The approval of Zepbound for sleep apnea follows a trend of weight loss drugs being recognized for their potential in treating conditions beyond obesity and diabetes. Earlier this year, Wegovy, another weight loss medication, received FDA approval for preventing strokes and heart attacks. Research into the potential applications of these medications continues to expand, with ongoing investigations into their effectiveness in treating addiction and certain types of cancer. This highlights the evolving role of weight loss drugs in addressing a broader range of health concerns.
