Is Zepbound Approved for Sleep Apnea? FDA Label Facts
Is Zepbound approved for sleep apnea? Yes, in the United States. The FDA announced on 20 December 2024 that it approved Zepbound (tirzepatide) for moderate to severe obstructive sleep apnea in adults with obesity. It is used with a reduced-calorie diet and more physical activity.
The FDA called it the first drug treatment option for certain patients with obstructive sleep apnea. The approval rests on two 52-week trials. It does not cover everyone with sleep apnea.
Short answer
- Approved?
- Yes, in the US, for moderate to severe obstructive sleep apnea in adults with obesity.
- Based on
- Two randomized, double-blind, placebo-controlled studies of 469 adults without type 2 diabetes.
- Does it replace CPAP?
- No source says so. The label says stopping PAP was not evaluated.
Sources: Zepbound FDA label; FDA press announcement, 20 December 2024
Who is covered by the Zepbound sleep apnea approval?
Adults who have both moderate to severe obstructive sleep apnea and obesity. Sleep apnea without obesity is not part of it.
| Item | What the record says |
|---|---|
| Condition | Moderate to severe obstructive sleep apnea, defined in the trials as an apnea-hypopnea index (AHI) of 15 or more |
| Weight | Obesity, defined in the trials as a BMI of 30 or more |
| Age | Adults |
| Alongside | A reduced-calorie diet and increased physical activity |
| Not studied | People with type 2 diabetes (excluded from the trials); when or whether to stop PAP |
The FDA says the better sleep apnea scores are likely related to weight loss with Zepbound. Everyone in the trials also got diet advice and activity counseling.
Sources: Zepbound FDA label; FDA press announcement, 20 December 2024
What did the Zepbound sleep apnea trials find?
Breathing pauses per hour of sleep fell far more on tirzepatide than on placebo in both trials. The FDA called the drop statistically significant and clinically meaningful.
The label names the two trials. Study 5 enrolled 234 people who were unable or unwilling to use positive airway pressure (PAP) therapy. Study 6 enrolled 235 people who were on PAP.
The AHI counts pauses and shallow breaths per hour. The New England Journal of Medicine paper gives the mean change at week 52. In one trial it was -25.3 events per hour on tirzepatide against -5.3 on placebo. In the other it was -29.3 against -5.5.
A later analysis found gains against the starting level as early as week 4. The gap from placebo was not significant until week 20. Side effects were mostly stomach related and mild to moderate. The label says they were like those in the weight-loss trials.
Sources: FDA press announcement, 20 December 2024; Zepbound FDA label; SURMOUNT-OSA, NEJM 2024; SURMOUNT-OSA time course analysis, 2025
What Zepbound dose is used for sleep apnea?
The sleep apnea maintenance doses are the two highest. The FDA label for Zepbound lists, for obstructive sleep apnea:
10 mg or 15 mg injected under the skin once weekly
Disclaimer: this is label information, not a recommendation. Dose decisions belong with a licensed clinician.
In the trials, people took Zepbound or placebo once weekly for 52 weeks. The Zepbound dose was not started at the top; it was raised over as many as 20 weeks to a maximum tolerated level of 10 mg or 15 mg, per the FDA label. The steps up to those doses are in our tirzepatide dosage guide.
Sources: Zepbound FDA label; FDA press announcement, 20 December 2024
Can Zepbound replace CPAP?
No official source says it can. The label states that the sleep apnea studies did not test when, or whether, people already using PAP should stop.
Sources: Zepbound FDA label
Is Mounjaro approved for sleep apnea?
Not in the US: the sleep apnea approval is on the Zepbound label only. A full-text search of the US Mounjaro label found no sleep apnea entry. Its uses include blood sugar control in type 2 diabetes, in adults and children 10 and older.
The EU Mounjaro product information points to sleep apnea trial results in section 5.1. It does not list sleep apnea as its own use. We found no Vietnamese regulator record on this. For the brand split, see is Zepbound the same as Mounjaro.
Sources: Mounjaro FDA label; EMA Mounjaro product information
Zepbound sleep apnea questions
Is Zepbound approved for sleep apnea?+
Yes, in the United States. The Zepbound label lists treating moderate to severe obstructive sleep apnea in adults with obesity as an approved use. The FDA announced the approval on 20 December 2024 and called it the first drug treatment option for certain patients with obstructive sleep apnea.
Who is Zepbound approved for in sleep apnea?+
Adults with moderate to severe obstructive sleep apnea (an AHI of 15 or more in the trials) and obesity (a BMI of 30 or more), used with a reduced-calorie diet and more physical activity. People with type 2 diabetes were excluded from the two trials.
What dose of Zepbound is used for sleep apnea?+
The Zepbound label lists maintenance doses of 10 mg or 15 mg injected under the skin once weekly for sleep apnea. This is label information, not a recommendation; dose decisions belong with a licensed clinician.
Can Zepbound replace a CPAP machine?+
No official source says so. The Zepbound label states that the sleep apnea studies did not evaluate the timing or appropriateness of stopping PAP in people who were already using it.
How fast does Zepbound work for sleep apnea?+
In a follow-up analysis of the trials, breathing measures improved compared with the start as early as week 4, but the difference from placebo was not significant until week 20.
Is Mounjaro approved for sleep apnea?+
Not in the US. A full-text search of the US Mounjaro label found no sleep apnea entry. The EU Mounjaro product information points to sleep apnea trial results in its section 5.1 but does not list it as a separate use.
Sources: Zepbound FDA label; FDA press announcement, 20 December 2024; SURMOUNT-OSA time course analysis, 2025; Mounjaro FDA label; EMA Mounjaro product information
Related tirzepatide guides
This guide is for educational purposes only and is not medical advice. It describes what the FDA, the Zepbound label and published trials report about tirzepatide for obstructive sleep apnea. Questions about your own sleep or medicine belong with a licensed clinician.