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FDA approves first medication for obstructive sleep apnea: Eli Lilly’s Zepbound GLP-1 agonist

  • The FDA has approved Eli Lilly’s Zepbound (tirzepatide) as the first-ever medication for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity, providing a pharmacological alternative to CPAP machines and surgery.
  • Zepbound works by activating GLP-1 and GIP receptors, leading to appetite suppression and weight loss, which helps alleviate OSA symptoms. Additional benefits include reductions in LDL cholesterol and blood pressure, lowering the risk of cardiovascular events.
  • In clinical trials, Zepbound significantly reduced the apnea-hypopnea index (AHI) compared to placebo. However, common side effects include nausea, diarrhea, vomiting, and abdominal discomfort, requiring patients to weigh the benefits against potential risks.

In a groundbreaking development, the U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Zepbound (tirzepatide) as the first medication for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This approval marks a significant advancement in the management of OSA, offering a pharmacological option where previously only devices (such as CPAP) or surgical interventions were available.

OSA is characterized by repeated episodes of partial or complete obstruction of the upper airway during sleep, leading to disrupted sleep patterns and reduced oxygen levels. Traditional treatment have focused on lifestyle modifications, continuous positive airway pressure (CPAP) devices, or surgical procedures. Zepbound introduces a novel approach by targeting the condition pharmacologically instead of using uncomfortable machines or invasive surgeries.

Tirzepatide, the active ingredient in Zepbound, functions as a dual agonist of the GLP-1 and GIP receptors, hormones involved in insulin secretion and appetite regulation. By activating these receptors, Zepbound reduces appetite and food intake, leading to weight loss – a critical factor in alleviating OSA symptoms. Thus tirzepatide offers several benefits to its users. Apart from relieving sleep apnea and weight loss, it also lowers LDL cholesterol and blood pressure, reducing the risk of cardiovascular events.

The FDA’s approval is based on data from two randomized, double-blind, placebo-controlled studies involving 469 adults without type 2 diabetes. Participants received either 10 or 15 milligrams of Zepbound or a placebo once weekly for 52 weeks. The primary efficacy measure was the change in the apnea-hypopnea index (AHI), which quantifies the number of apnea (cessation of breathing) and hypopnea (shallow breathing) events per hour during sleep. Results demonstrated that participants treated with Zepbound experienced a statistically significant and clinically meaningful reduction in AHI compared to the placebo group. Additionally, a greater proportion of those receiving Zepbound achieved remission or mild OSA with symptom resolution.

Common side effects reported with Zepbound include gastrointestinal symptoms such as nausea, diarrhea, vomiting, constipation, and abdominal discomfort. Patients are advised to discuss potential risks and benefits with their healthcare provider.

This approval not only provides a new treatment avenue for OSA patients but also underscores the evolving role of pharmacotherapy in managing sleep-related disorders. As research continues, medications like Zepbound may become integral components of care strategies for OSA and related conditions.

Prepared by:


Adam Tuszyner

Sources and further reading

  1. “FDA Approves First Medication for Obstructive Sleep Apnea” Food and Drug Administration (FDA) (December 20, 2024). Link: https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea.
  2. Malhotra, Atul, et al. “Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.” New England Journal of Medicine (2024).
  3. Flam, Charna “Zepbound Weight Loss Medication Approved by FDA to Treat Sleep Apnea” People.com (December 25, 2024). Link: https://people.com/zepbound-treat-sleep-apnea-approved-fda-8766411.
  4. Park, Alice “The First Sleep Apnea Drug Is Here.” Time (December 20, 2024). Link: https://time.com/7203597/zepbound-sleep-apnea-fda/.

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