Zepbound (tirzepatide) is FDA approved for moderate to severe obstructive sleep apnea in adults with obesity. The approval came on December 20, 2024, and the FDA called it the first medication for obstructive sleep apnea. In the SURMOUNT-OSA trials, tirzepatide cut breathing interruptions by about 25 to 29 events per hour over 52 weeks, compared with about 5 on placebo, while people lost 17.7% to 19.6% of their body weight. If you are new to the drug, start with our tirzepatide guide.
Key takeaways
- Zepbound is approved to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity, as an adjunct to a reduced-calorie diet and increased physical activity.
- SURMOUNT-OSA ran two 52-week trials: one in people not using PAP therapy and one in people using PAP.
- The apnea-hypopnea index fell by 25.3 events per hour (trial 1) and 29.3 (trial 2) with tirzepatide, versus 5.3 and 5.5 with placebo.
- Weight fell 17.7% and 19.6% with tirzepatide versus 1.6% and 2.3% with placebo.
- Mounjaro is not labeled for sleep apnea, and compounded tirzepatide is not FDA approved for anything, including OSA.
Is Zepbound FDA approved for sleep apnea?
Yes. On December 20, 2024 the FDA approved Zepbound for moderate to severe obstructive sleep apnea in adults with obesity. The FDA's press release described it as the first drug approved to treat OSA. The label pairs the drug with a reduced-calorie diet and more physical activity; it is not a stand-alone cure. Zepbound had already been approved on November 8, 2023 for chronic weight management, so the sleep apnea use was added to an existing label.
| Zepbound milestone | Date | What it covers |
|---|---|---|
| First approval (chronic weight management) | November 8, 2023 | Adults with a BMI of 30 or higher, or 27 or higher with a weight-related condition. |
| Sleep apnea approval | December 20, 2024 | Moderate to severe obstructive sleep apnea in adults with obesity. |
| Form | Ongoing | Once-weekly injection, 2.5 mg to 15 mg. No oral tablet exists. |
Source: FDA press releases of November 8, 2023 and December 20, 2024; Zepbound prescribing information (DailyMed).
What is sleep apnea, and what does AHI mean?
Obstructive sleep apnea is a condition in which the upper airway narrows or closes repeatedly during sleep, so breathing pauses or becomes shallow, and sleep is broken. The National Heart, Lung, and Blood Institute describes it as the most common type of sleep apnea and lists excess weight as one of the risk factors, because extra tissue around the airway makes it more likely to collapse.
Check your GLP-1 eligibility
Use our free BMI Calculator to see if you may qualify for provider-reviewed GLP-1 therapy.
Try the BMI Calculator →The apnea-hypopnea index, or AHI, is the standard score for how severe OSA is. It counts the number of apneas (full pauses in breathing) and hypopneas (partial reductions in airflow) per hour of sleep. A higher AHI means more interruptions per hour. When a trial says AHI fell by 25 events per hour, it means a person who had 25 fewer breathing interruptions every hour of sleep. The label uses the words "moderate to severe" for the OSA it covers; a sleep study is what tells you where you fall.
SURMOUNT-OSA: what the research shows
SURMOUNT-OSA was the trial program behind the approval. It enrolled adults with obesity and moderate to severe OSA and ran two parallel 52-week trials. Trial 1 was in people who were not using positive airway pressure (PAP) therapy. Trial 2 was in people who were using PAP. Each trial compared tirzepatide with placebo.
| SURMOUNT-OSA outcome at 52 weeks | Trial 1 (not on PAP): tirzepatide | Trial 1: placebo | Trial 2 (on PAP): tirzepatide | Trial 2: placebo |
|---|---|---|---|---|
| Change in AHI (events per hour) | -25.3 | -5.3 | -29.3 | -5.5 |
| Change in body weight | -17.7% | -1.6% | -19.6% | -2.3% |
Source: SURMOUNT-OSA, Malhotra et al., NEJM 2024; ClinicalTrials.gov NCT05412004.
Both trials point the same way: a drop of 25 to 29 breathing interruptions per hour with tirzepatide versus about 5 with placebo, and roughly 18% to 20% weight loss versus about 2%. The result held whether or not people were using PAP.
How does Zepbound help with sleep apnea?
The trial measured results, not the exact mechanism. Weight loss is the most likely driver: the label pairs the OSA indication with diet and activity, and the NHLBI lists excess weight as a risk factor for OSA because it adds tissue around the airway. Tirzepatide lowers appetite and slows stomach emptying by acting on the GLP-1 and GIP receptors, and the weight loss that follows is large. Whether the drug does anything for the airway beyond weight loss is not something SURMOUNT-OSA can prove, so we do not claim it.
Who qualifies for Zepbound for sleep apnea?
The label covers adults with obesity and moderate to severe obstructive sleep apnea. Two things follow from that. You need a sleep study that shows moderate to severe OSA, and you need to meet the label's definition of obesity. The same dosing schedule applies as for weight management: 2.5 mg once weekly for 4 weeks, then 2.5 mg steps after at least 4 weeks on each dose, with maintenance doses of 5, 10 or 15 mg. The same boxed warning about thyroid C-cell tumors and the same contraindications apply. A prescriber, ideally with your sleep study in hand, decides whether it fits.
Is Zepbound a replacement for CPAP?
The label does not say that, and neither should you. SURMOUNT-OSA trial 2 was in people who kept using PAP, and the drug still cut AHI by 29.3 events per hour on top of it. Whether you can reduce or stop PAP after weight loss is a decision for the clinician who manages your sleep apnea, usually with a repeat sleep study. Do not stop CPAP on your own because you started an injection.
Mounjaro, compounded tirzepatide and sleep apnea
Only Zepbound carries the OSA indication. Mounjaro contains the same drug, tirzepatide, but its label covers type 2 diabetes only. Compounded tirzepatide is not FDA approved for any use, including sleep apnea, and is not interchangeable with Zepbound. It has no trial data of its own; the numbers above come from the branded product. A licensed provider decides whether a compounded medication is appropriate for you.
What this means for compounded tirzepatide
If you have sleep apnea and are considering compounded tirzepatide for weight, be clear about what it is: the same molecule by an unapproved route, prescribed by a licensed clinician if they judge it appropriate, with no OSA indication and no OSA trial. Keep your sleep clinician in the loop. FormBlends compounded tirzepatide is priced by plan, not by dose; see pricing or begin the assessment.
Frequently Asked Questions
Is Zepbound FDA approved for sleep apnea?
Yes. The FDA approved Zepbound for moderate to severe obstructive sleep apnea in adults with obesity on December 20, 2024, calling it the first medication approved for OSA.
How does Zepbound help with sleep apnea?
In SURMOUNT-OSA, tirzepatide cut the apnea-hypopnea index by 25.3 to 29.3 events per hour over 52 weeks, alongside 17.7% to 19.6% weight loss. Weight loss is the most likely reason, since excess weight narrows the airway; the trial did not measure mechanism directly.
What GLP-1 is approved for sleep apnea?
Zepbound (tirzepatide), a dual GIP and GLP-1 receptor agonist. It is the only drug with an FDA-approved OSA indication. Mounjaro, the diabetes brand of tirzepatide, is not labeled for OSA.
Is there a Zepbound oral tablet?
No. Zepbound is a once-weekly injection under the skin, available in pens and vials from 2.5 mg to 15 mg. No tirzepatide tablet is approved.
Can I stop CPAP if I take Zepbound?
Not on your own. The trial in people on PAP kept them on PAP. Whether to change your CPAP use is a decision for the clinician managing your sleep apnea, usually after a repeat sleep study.
When was Zepbound released?
The FDA approved Zepbound for chronic weight management on November 8, 2023. The sleep apnea indication was added on December 20, 2024.
Sources
- FDA Approves First Medication for Obstructive Sleep Apnea, U.S. Food and Drug Administration, December 20, 2024.
- Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (SURMOUNT-OSA), Malhotra et al., New England Journal of Medicine, 2024.
- SURMOUNT-OSA study record (NCT05412004), ClinicalTrials.gov.
- Zepbound (tirzepatide) prescribing information, DailyMed, National Library of Medicine, revised 08/2026.
- Sleep Apnea, National Heart, Lung, and Blood Institute.
- FDA Approves New Medication for Chronic Weight Management, U.S. Food and Drug Administration, November 8, 2023.
- Mounjaro (tirzepatide) prescribing information, DailyMed, National Library of Medicine, revised 08/2026.
Next steps
For the Mounjaro side of the question, read is Mounjaro approved for sleep apnea. For sleep complaints on the drug itself, see tirzepatide and sleep, and for the names, what is the brand name for tirzepatide. Browse the tirzepatide hub for every other tirzepatide question. Talk to a clinician, and keep your sleep specialist involved. Compounded tirzepatide is not FDA approved and is not interchangeable with Zepbound or Mounjaro; a licensed provider decides whether it is appropriate for you.
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