Mounjaro and Zepbound for sleep apnoea: what did trials show?
Tirzepatide and sleep apnoea: the SURMOUNT-OSA results, the side effects, the US approval, India's status, and where CPAP fits.
Written for India. Reading from the US? US versionComing soon
Two 52-week trials tested tirzepatide 10 or 15 mg, the medicine in Mounjaro and Zepbound. It cut breathing pauses by 25 to 29 an hour, vs about 5 on placebo. Stomach side effects were common. The US approved Zepbound for sleep apnoea in December 2024. We found no separate Indian approval. A CPAP machine remains standard care.
Key takeaways
- In the SURMOUNT-OSA trials, tirzepatide 10 or 15 mg (the medicine in Mounjaro and Zepbound) cut breathing pauses by 25 to 29 an hour, vs about 5 on placebo.3
- Stomach side effects were common in those trials: in trial 1, nausea hit 25% on tirzepatide vs 10% on placebo, and diarrhoea 26% vs 13%.3
- The US approved Zepbound for moderate to severe sleep apnoea with obesity on 20 December 2024; we found no matching Indian approval as of 5 October 2026.5,9,10
- India's 2014 sleep apnoea guidelines call positive airway pressure (a CPAP machine) the mainstay of treatment, and the tirzepatide trials did not test stopping it.2,4
- An AIIMS-led review estimated that 104 million working-age Indians have sleep apnoea, 47 million of them moderate to severe.1
On this page
- What is obstructive sleep apnoea?
- How does extra weight affect sleep apnoea?
- What did the SURMOUNT-OSA trials test?
- How much did tirzepatide cut breathing pauses?
- What side effects did people have in the trials?
- Is Mounjaro approved for sleep apnoea in India?
- Does a weight-loss medicine replace a CPAP machine?
- What about semaglutide (Ozempic, Wegovy) or liraglutide?
- What happens to sleep apnoea if the medicine stops?
- Questions people ask
- How we researched this
- GLP-1 medicines are prescription-only. A government statement on 1 Apr 2026 said only endocrinologists, internal-medicine specialists and cardiologists can prescribe them.21 CDSCO expert-committee minutes attach a similar condition to some approvals (endocrinologist or internal-medicine specialist), but we found no rule covering every brand.22,23
- They have serious risks as well as common side effects: Guide 5: Side effects and risks.
- Trial figures here are group averages. They are not a promise for any one person, and this page doesn't say who these medicines suit.
What is obstructive sleep apnoea?
It is a condition where the airway in the throat keeps collapsing during sleep. Breathing stops or gets very shallow, again and again, through the night.2,6
India's 2014 guidelines are called INOSA. They were written under the Health Ministry's Department of Health Research.2 They say the collapse leads to snoring, broken sleep and low oxygen.2 The condition is linked with diabetes, high blood pressure, heart disease, stroke and road accidents.2
Doctors count the pauses with an overnight sleep study. The count per hour is the apnoea-hypopnoea index (AHI).3,6 The US Zepbound label calls 15 to 30 an hour moderate, and 30 or more severe.4
How common is it in India? A 2023 review led by AIIMS doctors pooled 8 Indian studies of 11,009 adults who had sleep studies.1 It found sleep apnoea in 11% overall: 13% of men and 5% of women.1 About 5% had moderate to severe disease.1 The authors estimate 104 million working-age Indians have it, 47 million of them moderate to severe.1
The guidelines ask that people with snoring, daytime sleepiness, obesity or high blood pressure have a full sleep check.2 More on weight-linked conditions is in Guide 1: weight and health in Indians.
How does extra weight affect sleep apnoea?
Weight and sleep apnoea move together. In a US study of 690 adults, a 10% weight loss predicted a 26% fall in breathing pauses.16
That study followed working adults in Wisconsin over 4 years.16 A 10% weight gain predicted a 32% rise in the AHI. It also predicted 6 times the odds of moderate to severe disease.16 It was observational: it shows a link, not proof that weight change caused it.
The American Thoracic Society's 2018 guideline makes a strong recommendation for people with sleep apnoea and overweight or obesity.15 It advises a full lifestyle programme: a lower-calorie diet, more activity, and behaviour support.15 It says medicines and weight-loss surgery suit "selected patients" who need more help.15
Weight is not the only cause. The INOSA guidelines list other causes to rule out. These include an underactive thyroid, large tonsils and the shape of the face and jaw.2 The full range of weight options is in Guide 3: your options.
What did the SURMOUNT-OSA trials test?
They were two 52-week trials of tirzepatide vs placebo in 469 adults with obesity and moderate to severe sleep apnoea. Eli Lilly, which makes tirzepatide, funded them.3
- Trial 1: 234 people not using a breathing machine, because they couldn't or wouldn't.3,4
- Trial 2: 235 people already using positive airway pressure (PAP), such as a CPAP machine.3,4 They paused it for 7 days before each sleep study.3
Tirzepatide is the medicine in Mounjaro, and in Zepbound in the US (what is tirzepatide?). The dose started at 2.5 mg a week and rose over up to 20 weeks.3 Each person stayed on the highest dose they could tolerate, 10 or 15 mg.3 Everyone got diet and activity advice.3 The dose steps are explained in Mounjaro doses explained.
Who was in them. People needed a BMI of 30 or more (27 in Japan) and an AHI of at least 15.3 People with type 1 or type 2 diabetes were left out.3 The average BMI was about 39, and the average AHI about 50 pauses an hour.3 Men were 67% and 72% of the two trials; Asian people were 20% and 14%.4
India's obesity cut-off is a BMI of 25, lower than the trials' 30.12 We found no SURMOUNT-OSA results for people at the lower Indian cut-offs, or for Indians as a group.
How much did tirzepatide cut breathing pauses?
By about half. Breathing pauses fell by 25 an hour in trial 1 and 29 in trial 2, vs about 5 on placebo.3
| After 52 weeks | Trial 1 (no PAP) | Trial 2 (on PAP) |
|---|---|---|
| Change in pauses an hour | −25.3 vs −5.33 | −29.3 vs −5.53 |
| Change in pauses, % | −51% vs −3%3 | −59% vs −3%3 |
| Pauses at least halved | 61% vs 19% of people3 | 72% vs 23%3 |
| No sleep apnoea, or mild without sleepiness | 42% vs 16%3 | 50% vs 14%3 |
| Weight lost | 18% vs 2%3 | 20% vs 2%3 |
Tirzepatide 10 or 15 mg a week vs placebo. "Mild without sleepiness" = AHI 5 to 14 with a low daytime-sleepiness score. Source: Malhotra et al., NEJM 2024 (Lilly-funded). Checked 5 October 2026.
A worked example. Take someone starting at 51 pauses an hour, the trial 1 average. Losing the average 25 would leave about 26.3 That is still in the 15 to 30 "moderate" band.4 This is our arithmetic, not a forecast. For a 100 kg person, 18% is about 18 kg.
Blood pressure fell too. Systolic blood pressure dropped 9.5 vs 1.8 points in trial 1, and 7.6 vs 3.9 in trial 2, measured at week 48.3 A marker of inflammation (hsCRP) and a measure of low oxygen during sleep also fell more on tirzepatide.3
Limits the authors list. The trials lasted 52 weeks, so they can't show long-term heart outcomes.3 They did not test people without obesity.3 The European regulator adds a caveat about trial 2. PAP was paused before each test, so it can't show any added benefit on top of PAP.7
Weight-trial results for everyone are in how much weight people lose on Ozempic or Mounjaro.
What side effects did people have in the trials?
Mostly stomach effects. Diarrhoea, nausea, vomiting and constipation were all more common on tirzepatide than on placebo.3
| Side effect | Trial 1: tirzepatide vs placebo | Trial 2: tirzepatide vs placebo |
|---|---|---|
| Diarrhoea | 26% vs 13%3 | 22% vs 9%3 |
| Nausea | 25% vs 10%3 | 22% vs 5%3 |
| Vomiting | 18% vs 4%3 | 9% vs 1%3 |
| Constipation | 16% vs 3%3 | 15% vs 4%3 |
| Stopped because of side effects | 4% vs 2%3 | 3% vs 7%3 |
Share of people with each side effect over 52 weeks. Source: Malhotra et al., NEJM 2024, Table 4. Checked 5 October 2026.
The authors say most stomach effects were mild to moderate and came during the dose-raising weeks.3 Severe or serious stomach events hit 4 people in each trial on tirzepatide, and none on placebo.3 Two people in trial 2 had confirmed pancreatitis (an inflamed pancreas), both on tirzepatide.3 No one died in either trial.3
The US label says side effects in these trials were similar to those in the weight-loss trials.4 The full list for Mounjaro is in Mounjaro side effects.
- Stomach effects are very common. The EU Mounjaro leaflet lists nausea and diarrhoea as very common (more than 1 in 10 people).7
- Pancreatitis is uncommon on the EU Mounjaro label (1 in 100 to 1 in 1,000 people). The sign is severe stomach pain, sometimes to the back, that won't go away.7
- Gallstones and an inflamed gallbladder are uncommon on the EU Mounjaro label (1 in 100 to 1 in 1,000 people).7
- Dehydration from vomiting or diarrhoea can injure the kidneys.4
- Thyroid warning. Ruled out by the US label for people with a personal or family history of MTC, a thyroid cancer, or MEN 2; tell your doctor if this applies.4
- Surgery and sedation. The US label notes reports, after approval, of stomach contents being breathed into the lungs under anaesthesia. It asks people to tell doctors about planned procedures.4
- The contraceptive pill may work less well. The US label advises a non-oral or backup method for 4 weeks after starting and after each dose step.4
Pancreatitis and gallbladder problems have their own post: Can GLP-1s cause pancreatitis or gallbladder problems?
Answer a few questions and see what Indian guidelines say a doctor may consider. No sign-up.
Is Mounjaro approved for sleep apnoea in India?
We found no separate Indian approval for sleep apnoea. Mounjaro launched in India in March 2025 for type 2 diabetes and long-term weight management.9
- United States. On 20 December 2024 the FDA approved Zepbound (tirzepatide) for moderate to severe sleep apnoea in adults with obesity.5 The FDA called it the first medicine approved for the condition.5
- European Union. In December 2024 the EU regulator agreed tirzepatide improves sleep apnoea in adults with obesity.6 It decided a separate indication was not needed, because the existing weight indication already covers these patients.6 The trial data went into the label instead.6,7
- Australia. The Conversation reported in June 2025 that Australia's regulator had approved Mounjaro for sleep apnoea.8
- India. Lilly's launch covered weight management at a BMI of 30, or 27 with a weight-related condition, plus type 2 diabetes.9 Tirzepatide is on CDSCO's 2024 new-drug list, dated 19 January 2024, for type 2 diabetes. The 2025 and 2026 lists don't mention it.10 New uses of an approved drug may not appear on these lists, so this is not proof. We found no news report of an Indian sleep apnoea approval as of 5 October 2026.
- India's label. A Lilly India promotional summary for doctors reports that the Indian Mounjaro label lists obstructive sleep apnoea among the weight-related conditions, at a BMI of 27 or more.24 We could not open the Indian label itself. If the summary is right, India, like the EU, covers sleep apnoea inside the weight indication, not as a separate approval.6,24
The Indian launch thresholds are label numbers, not India's lower BMI cut-offs.9,12 Separately, India's 2025 obesity guideline (ESI) says medicine "should be considered" at a BMI above 25 with a condition such as sleep apnoea.11 That is what a doctor may consider, not a rule about who gets it.
Availability is covered in Is Mounjaro available in India? Zepbound itself gets a short Answer soon: Is Zepbound available in India?.
Does a weight-loss medicine replace a CPAP machine?
No guideline we read says so. India's 2014 guidelines call positive airway pressure the mainstay of treatment. They call CPAP the "gold standard" for moderate to severe disease.2
Positive airway pressure is a treatment designed to stop the airway narrowing during sleep.6 The American Academy of Sleep Medicine's 2019 guideline strongly recommends PAP for adults with sleep apnoea and excessive sleepiness.13 Its review found PAP cut sleepiness, blood pressure and car accidents compared with no treatment.13
The tirzepatide trials do not answer the swap question:
- The US label says the studies "did not evaluate the timing or appropriateness of PAP discontinuation" in people who used it well.4
- The academy's 2025 article for doctors says tirzepatide is not meant to replace CPAP. It adds that "CPAP should not be discontinued without proper reassessment".14
Other options in the Indian guidelines. Mouth guards (oral appliances) are for mild to moderate disease, or when PAP fails.2 Surgery is recommended when PAP fails or can't be tolerated.2 Weight-loss surgery is strongly recommended at a BMI of 35 or more.2 The same guidelines cite a review in which 62% of people still had an AHI above 15 after surgery. They advise a repeat sleep study.2 Our post comparing surgery and medicines is on the way: Bariatric surgery vs GLP-1 medicines.
What about semaglutide (Ozempic, Wegovy) or liraglutide?
We found no published semaglutide trial that measured sleep apnoea with sleep studies. The older medicine liraglutide had one trial, with a smaller effect.17,19
Semaglutide 2.4 mg (Wegovy). In June 2026 Novo Nordisk, which makes it, presented a look back at the SELECT heart trial.18 Among people without sleep apnoea at the start, 30 on semaglutide reported it later, vs 65 on placebo.18 Sleep apnoea was counted from a questionnaire and side-effect reports, not sleep studies.18 Novo Nordisk calls the analysis "hypothesis-generating". Semaglutide is not approved for sleep apnoea.18 Ozempic is a lower-dose semaglutide brand for diabetes: Wegovy vs Ozempic.
Liraglutide 3.0 mg (Saxenda). The SCALE Sleep Apnea trial tested it for 32 weeks in 359 adults with obesity who didn't use CPAP.17 Breathing pauses fell 12.2 an hour vs 6.1 on placebo.17 Weight fell 5.7% vs 1.6%.17 Nausea hit 27% vs 7%, and Novo Nordisk sponsored the trial.17 More is in Liraglutide (Saxenda) in India.
A 2025 review pooled all the trials it could find: SCALE and the two SURMOUNT-OSA trials, 828 people in all.19 It says the evidence "remains limited" to these three trials.19 Comparing tirzepatide and semaglutide more broadly: Mounjaro vs Ozempic.
What happens to sleep apnoea if the medicine stops?
The sleep apnoea trials did not measure what happens after stopping. In a separate tirzepatide weight trial, people switched to placebo regained much of the weight they had lost.3,20
The sleep academy's article says stopping tirzepatide "may affect any reductions in AHI".14 It describes the medicine as possibly long-term, "much like blood pressure medication".14 The SURMOUNT-OSA authors note sleep apnoea lasts many years, but their trials stopped at 52 weeks.3
Stopping is covered in Guide 9: stopping and the long term. A full post is coming: What happens when you stop Ozempic or Mounjaro?.
Questions people ask
Is Mounjaro approved for sleep apnoea in India?
We found no separate Indian approval for sleep apnoea. Mounjaro launched in India in March 2025 for type 2 diabetes and long-term weight management. A Lilly India promotional summary reports that the Indian label lists sleep apnoea among the weight-related conditions, at a BMI of 27 or more. We could not open the Indian label itself. The US approved tirzepatide for sleep apnoea under the Zepbound brand in December 2024.9,10,24,5
Can Mounjaro cure sleep apnoea?
Not for everyone in the trials. After 52 weeks, 42% in trial 1 and 50% in trial 2 on tirzepatide had no sleep apnoea, or only mild sleep apnoea without daytime sleepiness. On placebo it was 16% and 14%. The others did not reach this mark. The trials did not test whether the effect lasts beyond 52 weeks.3
Can people stop their CPAP machine once they start Mounjaro?
The trials did not test this. The US label says the studies did not evaluate the timing or appropriateness of stopping CPAP. The US sleep medicine academy writes that CPAP should not be stopped without proper reassessment.4,14
Does Ozempic or Wegovy help sleep apnoea?
We found no published trial of semaglutide that measured sleep apnoea with sleep studies. In a SELECT heart trial look-back, fewer people on semaglutide 2.4 mg (Wegovy) reported new sleep apnoea: 30 vs 65. Semaglutide is not approved for sleep apnoea.18
What dose of tirzepatide was used for sleep apnoea?
The trials raised the dose over up to 20 weeks. Each person stayed on the highest dose they could tolerate, 10 or 15 mg a week. The US Zepbound label lists 10 or 15 mg as the sleep apnoea maintenance dose.3,4
How we researched this
We read the full SURMOUNT-OSA paper and its tables. We also read the US Zepbound and EU Mounjaro labels. We also read the FDA approval notice and the EU regulator's December 2024 decision.
For India we used the 2014 INOSA guidelines, a 2023 AIIMS-led prevalence review, ESI 2025 and the 2009 Indian consensus. We searched CDSCO's 2024–2026 new-drug lists and news reports for an Indian sleep apnoea approval, and found none. We could not find the Indian Mounjaro label online, so its sleep apnoea wording comes from a Lilly India promotional summary, which we do not link.
For semaglutide we found only a SELECT look-back, reported by a trade publication from a 2026 conference. We could not open a full paper for it, so we give only its headline numbers.
Before you move on
- Tirzepatide cut breathing pauses by about half in two 52-week trials, with common stomach side effects.
- The US approved it for sleep apnoea as Zepbound; we found no Indian approval for this use.
- The trials did not test stopping CPAP, and India's guidelines call PAP the mainstay of treatment.
- We found no semaglutide sleep-study trial; liraglutide's trial showed a smaller effect.
More from the India blog
The monthly India update
An independent guide to GLP‑1 medicines. We don't sell medicines, take drug-company money or earn clinic commissions. Once a month: new brands, price changes, approvals and recalls. How we write
Sources
- Suri TM, Ghosh T, Mittal S, Hadda V, Madan K, Mohan A (AIIMS New Delhi). Systematic review and meta-analysis of the prevalence of obstructive sleep apnea in Indian adults. Sleep Med Rev 2023;71:101829. doi:10.1016/j.smrv.2023.101829 · PMID 37517357
- Sharma SK et al.; INOSA Guidelines Working Group. Consensus & evidence-based INOSA Guidelines 2014 (first edition). Indian J Med Res 2014;140(3):451–68. Developed under the Department of Health Research, Ministry of Health & Family Welfare. PMC4248396 · PMID 25366217
- Malhotra A et al. Tirzepatide for the treatment of obstructive sleep apnea and obesity (SURMOUNT-OSA). N Engl J Med 2024;391:1193–205. Funded by Eli Lilly. doi:10.1056/NEJMoa2404881 · PMC11598664 (full text)
- Zepbound (tirzepatide) US Prescribing Information, revised 08/2026. US label, not the Indian one. pi.lilly.com/us/zepbound-uspi.pdf
- US Food and Drug Administration. FDA approves first medication for obstructive sleep apnea. Press announcement, 20 Dec 2024. fda.gov
- European Medicines Agency. Outcome of assessment on use of Mounjaro in treatment of obstructive sleep apnoea. EMA/576853/2024, 13 Dec 2024. ema.europa.eu (PDF)
- Mounjaro (tirzepatide) EU product information: summary of product characteristics (section 5.1, SURMOUNT-OSA) and package leaflet (section 4). EU label, not the Indian one. ema.europa.eu (PDF)
- Fatima Y, Aouira N. The weight loss drug Mounjaro has been approved to treat sleep apnoea. How does it work? The Conversation, 12 Jun 2025. theconversation.com
- IPP Bureau. Lilly launches Mounjaro in India for treatment of obesity and type 2 diabetes. Indian Pharma Post, 24 Mar 2025. indianpharmapost.com
- CDSCO. Lists of new drugs approved in the years 2024, 2025 and 2026 till date (2024 list dated 26 Nov 2024; last entries 15 Oct 2025 and 10 Mar 2026). Checked 5 Oct 2026. cdsco.gov.in · archived copy · Archived copies: 2025, 2026
- Madhu SV et al. ESI clinical practice guidelines for the evaluation and management of obesity in India. Indian J Endocrinol Metab 2025;29(4):355–65. Recommendation B.1. doi:10.4103/ijem.ijem_680_25 · PMC12410957
- Misra A et al. Consensus statement for diagnosis of obesity, abdominal obesity and the metabolic syndrome for Asian Indians. J Assoc Physicians India 2009;57:163–70. PMID 19582986
- Patil SP et al. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med 2019;15(2):335–43, with its systematic review (pp. 301–34). doi:10.5664/jcsm.7640 · PMID 30736887 · review, PMID 30736888
- Robards K. What clinicians should know about prescribing tirzepatide for sleep apnea. American Academy of Sleep Medicine, 2025. aasm.org
- Hudgel DW et al. The role of weight management in the treatment of adult obstructive sleep apnea. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med 2018;198(6):e70–87. doi:10.1164/rccm.201807-1326ST · PMID 30215551
- Peppard PE et al. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA 2000;284(23):3015–21. doi:10.1001/jama.284.23.3015 · PMID 11122588
- Blackman A et al. Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial. Int J Obes 2016;40(8):1310–9. Sponsored by Novo Nordisk. doi:10.1038/ijo.2016.52 · PMC4973216
- Semaglutide associated with lower incidence of OSA in post hoc analysis. Sleep Review, 26 Jun 2026 (report of a Novo Nordisk SELECT post hoc analysis presented at the ADA Scientific Sessions 2026). sleepreviewmag.com
- Altobaishat O et al. Safety and efficacy of glucagon-like peptide-1 receptor agonists in patients with obstructive sleep apnea: a systematic review and meta-analysis of randomized controlled trials. Eur Clin Respir J 2025;12(1):2484048. doi:10.1080/20018525.2025.2484048 · PMID 40144943
- Aronne LJ et al. Continued treatment with tirzepatide for maintenance of weight reduction in adults with obesity: the SURMOUNT-4 randomized clinical trial. JAMA 2024;331(1):38–48. Funded by Eli Lilly. doi:10.1001/jama.2023.24945 · PMID 38078870
- PIB Research. GLP-1 Drugs: Use, Risks, and Regulation. Government of India backgrounder, 1 Apr 2026. static.pib.gov.in (PDF)
- CDSCO. Recommendations of the Subject Expert Committee (Endocrinology & Metabolism), meeting of 20–21 April 2023. Item 1, tirzepatide. PDF · Archived copy
- CDSCO. Recommendations of the Subject Expert Committee (Endocrinology & Metabolism), meeting of 13–14 February 2024. Items 3–4, semaglutide. PDF · Archived copy
- Eli Lilly India. Mounjaro summary for healthcare professionals (promotional material), citing "Tirzepatide (Mounjaro) India Prescribing Information, updated March 2025". Weight-management indication, comorbid conditions "e.g., hypertension, dyslipidaemia, obstructive sleep apnoea…". Not linked because it is promotional; we could not open the Indian label itself. Checked 5 Oct 2026.
Last checked 5 Oct 2026 · Next review due 5 Apr 2027 · Report an error
How this post was made. Written by the GLP Guidebook team from the sources above. It's general information, not medical advice. Talk to a qualified doctor before starting, stopping or changing any medicine. How we write