Weight-Loss Injection Zepbound (Tirzepatide) Receives FDA Approval for Obstructive Sleep Apnea

On 20 December 2024, the United States Food and Drug Administration (FDA) approved Zepbound (Eli Lilly), a once-weekly injection containing tirzepatide, for treating moderate and severe obstructive sleep apnea in adults with obesity, alongside a reduced-calorie diet and increased physical activity.

Obesity and obstructive sleep apnea (commonly referred to as snoring disease) are major health problems in modern society. FDA approval of tirzepatide for moderate and severe sleep apnea associated with obesity represents a milestone in treatment. Until now, sleep apnea treatment had relied on mechanical support such as positive airway pressure (PAP) therapy. Zepbound, administered as a weekly injection, marks the first approval of a medicine for this condition.

Sleep Apnea and Obesity: What Is the Connection?

Sleep apnea is a condition in which repeated obstruction of the upper airway during sleep interrupts breathing, particularly in people who are overweight. Symptoms include loud snoring, repeated awakenings, and daytime sleepiness. Sleep apnea is also associated with serious complications, including cardiovascular disease. Excess weight is considered a leading risk factor.

Tirzepatide was first approved in May 2022 for treating type 2 diabetes under the brand name Mounjaro, and in November 2023 for weight loss under the name Zepbound. Approval for sleep apnea has expanded its treatment scope and is considered an important advance.

SURMOUNT-OSA: Evidence and Results

Zepbound's approval for sleep apnea was based on the results of SURMOUNT-OSA, two phase 3 double-blind randomized controlled trials. Conducted at 60 centers in nine countries, these studies examined 703 patients diagnosed with obesity and moderate to severe sleep apnea.

• The first study: Included 469 participants who were unable or unwilling to use PAP therapy.

• The second study: Included 234 people who had used PAP for at least three months and planned to continue these therapies.

In both groups, participants received 10 mg or 15 mg of tirzepatide or placebo once weekly. After 52 weeks, those receiving tirzepatide had a marked reduction in the apnea-hypopnea index (AHI) compared with placebo:

• AHI decreased by 27-30 per hour in those receiving tirzepatide,

• compared with a decrease of only 4-6 in the placebo group.

Participants receiving tirzepatide also lost an average of 20% more weight than those receiving placebo. These results indicate that tirzepatide's effectiveness in treating sleep apnea is largely related to the reduction in body weight.

Side Effects and Real-World Data

Side effects of tirzepatide include nausea, diarrhea, constipation, abdominal pain, fatigue, injection-site reactions, reflux, and, rarely, “alınırık kaybı” (an unclear phrase in the source). Although adherence was high in SURMOUNT-OSA, approximately 50% of patients starting GLP-1 receptor agonists in real-world practice are known to stop treatment within the first 12 months.

Conclusion and Future Prospects

Approval of tirzepatide for obstructive sleep apnea represents a major advance in treatment approaches. However, ensuring adherence and addressing equity issues will be decisive factors in its success. The place and impact of this new treatment in clinical practice will become clearer over time.