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Mounjaro for sleep apnoea: what did the TGA approve in Australia?

The 2025 approval for obstructive sleep apnoea, what the SURMOUNT-OSA trials found, how it sits with CPAP, side effects, and the PBS.

GLP Guidebook teamPublished 12 Oct 20266 min read13 sourcesWritten from published sources

Written for Australia. Other country versions are coming.

The short answer

Mounjaro (tirzepatide) is approved in Australia to treat moderate to severe obstructive sleep apnoea in adults with obesity, reported in June 2025. In two 52-week trials, breathing pauses per hour fell by 55% and 63%, against 5% and 6% on a dummy injection. It is not PBS-subsidised. Stomach side effects were common.

Key takeaways

  • The Australian Mounjaro PI lists treatment of moderate to severe obstructive sleep apnoea in adults with obesity as an approved use, alongside diabetes and weight management.1
  • In SURMOUNT-OSA trial 1, breathing pauses per hour fell 55.0% on tirzepatide over 52 weeks, against 5.0% on a dummy injection; Eli Lilly paid for it.1,3
  • In trial 2, where people kept using their CPAP machines, 51.5% on tirzepatide reached remission or mild sleep apnoea without daytime sleepiness, against 13.6% on the dummy.1
  • In the sleep apnoea trials, 23.6% on tirzepatide felt sick against 7.7% on a dummy injection, and 24.0% had diarrhoea against 10.7%.1
  • Mounjaro is not subsidised on the PBS for any use, and Eli Lilly has stopped its application for a type 2 diabetes listing.5
On this page
  1. What did the TGA approve Mounjaro for in sleep apnoea?
  2. What is obstructive sleep apnoea?
  3. How well did tirzepatide work for sleep apnoea in trials?
  4. Does Mounjaro replace CPAP for sleep apnoea?
  5. Is Mounjaro on the PBS for sleep apnoea?
  6. What are the side effects of Mounjaro in sleep apnoea?
  7. Questions people ask
  8. How we researched this

What did the TGA approve Mounjaro for in sleep apnoea?

The treatment of moderate to severe obstructive sleep apnoea (OSA) in adults with obesity. newsGP reported the approval on 4 June 2025.1,2

Before you go further
  • Mounjaro is a prescription-only medicine in Australia. A prescriber decides whether it suits you.
  • Label facts here come from the Australian Product Information (PI), version A14.0, October 2026.1
  • We don't publish medicine prices for Australia. The TGA treats price information for prescription medicines as advertising unless strict rules are met.7
  • Every risk of tirzepatide is in Guide 5: Side effects and risks.
  • This post describes the label and trials. It is not a plan for your treatment, and no medicine guarantees any result.

Tirzepatide is the medicine in Mounjaro. It copies two gut hormones, GIP and GLP‑1, which make you feel full and slow how fast the stomach empties.1 In Australia the same brand covers these approved uses:1

  • type 2 diabetes in adults, and in children aged 10 and over weighing at least 50 kg;
  • chronic weight management in adults with a BMI of 30, or 27 with a weight-related condition;
  • moderate to severe obstructive sleep apnoea in adults with obesity.

newsGP described the indication as covering adults "living with obesity (BMI over 30)".2 The same report called it the first medicine indicated to treat OSA in people with obesity.2

What is obstructive sleep apnoea?

A problem with breathing during sleep, where the airway is partly or completely blocked at times. Being overweight raises the risk.4

  • Signs: loud snoring, waking up gasping or choking, and daytime sleepiness.4
  • Diagnosis: often an overnight sleep study, where breathing and oxygen levels are monitored.4
  • Usual treatments: continuous positive airway pressure (CPAP), where a pump feeds air into a mask; losing weight; and mouth guards fitted by a dentist.4
  • Why it matters: people with OSA are at higher risk of car and workplace accidents, and of heart disease and stroke.4

Severity is measured by the apnoea-hypopnoea index (AHI): the number of times an hour breathing stops or becomes shallow. The trials below used it as their main result.1

How well did tirzepatide work for sleep apnoea in trials?

In two 52-week trials, breathing pauses per hour fell by about half or more on tirzepatide, and by about 5% on a dummy injection.1

The SURMOUNT-OSA trials enrolled 469 adults with moderate to severe OSA and obesity. People with type 2 diabetes were excluded. Everyone took the highest dose they tolerated, 10 or 15 mg a week.1

Trial 1Tirzepatide vs dummy, no CPAP

234 adults who could not or would not use CPAP, starting at about 51 to 54 pauses an hour, for 52 weeks. Eli Lilly paid for the trials.1,3

Change in breathing pauses per hour (AHI)

Tirzepatide−55%
Dummy injection−5%

About 27 fewer pauses an hour on tirzepatide, against 5 fewer on the dummy.

Trial 2Tirzepatide vs dummy, on CPAP

235 adults already using CPAP, starting at about 46 to 53 pauses an hour, for 52 weeks.1

Change in breathing pauses per hour (AHI)

Tirzepatide−63%
Dummy injection−6%

About 30 fewer pauses an hour on tirzepatide, against 6 fewer on the dummy.

Australian Mounjaro PI, Tables 18 and 19. The published trial reports slightly different averages (25.3 and 29.3 fewer pauses) because it used a different analysis.1,3

Remission or mild. By week 52, 43.0% in trial 1 and 51.5% in trial 2 had either no OSA or mild OSA without daytime sleepiness. On the dummy it was 14.9% and 13.6%.1 So roughly half still had sleep apnoea at a level above mild.

Weight. People on tirzepatide also lost 18.1% and 20.1% of their weight, against 1.3% and 2.3% on the dummy.1 The PI reports the two side by side; it does not say how much of the change came from weight loss.

Free toolQuestions for your sleep doctor or GP

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Open the question list

Does Mounjaro replace CPAP for sleep apnoea?

The label doesn't say so. Trial 2 tested tirzepatide in people who kept using CPAP, and trial 1 in people who could not or would not use it.1

Both trials compared tirzepatide with a dummy injection, not with CPAP.1 So they show what the medicine added, not whether it can stand in for a machine. Healthdirect lists CPAP, weight loss and mouth guards as treatments.4

  • Sleep tests. The trials measured OSA with overnight sleep studies at the start and at 52 weeks.1 A follow-up study is how a sleep doctor would see a change.
  • Driving. Untreated OSA raises the risk of road accidents.4 Any change to treatment is worth talking through with your sleep doctor or GP first.
  • How people felt. Questionnaire scores for sleep-related problems and disturbed sleep improved more on tirzepatide than on the dummy.1

Is Mounjaro on the PBS for sleep apnoea?

No. Mounjaro is not PBS-subsidised for any use as of October 2026, and we found no PBS application for sleep apnoea.5

The PBAC recommended Mounjaro for type 2 diabetes in March 2026. Eli Lilly then told the government it was "not proceeding in the PBS listing process", and the process ceased.5 The PBAC also says Lilly has not applied to list tirzepatide for overweight or obesity.6

So any Mounjaro for sleep apnoea is a private prescription. We don't publish prices.7 Our posts on Mounjaro and the PBS and private health insurance explain what that means for cost.

What are the side effects of Mounjaro in sleep apnoea?

Mostly stomach effects, the same pattern as in the weight trials. About 1 in 4 had diarrhoea and about 1 in 4 felt sick.1

Side effects in the sleep apnoea trials
% of people, tirzepatide vs dummy injection, Australian Mounjaro PI, Table 5
Australian Mounjaro PI, section 4.8, SURMOUNT-OSA trials 1 and 2 combined (233 on tirzepatide, 234 on dummy), checked 12 Oct 2026.1

So about 16 in 100 felt sick because of the medicine itself, by our arithmetic (23.6 minus 7.7).

RisksThe risks, in brief
  • Pancreatitis has been reported with tirzepatide. The PI says to stop if it is suspected and not to restart if it is confirmed.1
  • Gallbladder disease, including gallstones, is listed as uncommon (1 in 100 to 1 in 1,000) in the PI.1
  • The contraceptive pill may work less well when starting and after each dose step. The PI advises a non-oral method, or adding a barrier method, for 4 weeks after each.1,8
  • Anaesthesia. Food can stay in the stomach longer, raising the risk of inhaling it under anaesthesia or deep sedation. Tell your anaesthetist.9 See surgery or a colonoscopy on a GLP‑1.
  • Sudden loss of sight (NAION) has been reported with GLP‑1 medicines. Seek urgent care for any sudden vision loss.10
Full detail in Guide 5: Side effects and risks →
Get help now: call triple zero (000) if an illness is critical or life-threatening.11 For advice when you are not sure what to do, call the healthdirect nurse helpline free on 1800 022 222, 24 hours a day.11 If you think you have taken too much of a medicine, call the Poisons Information Centre on 13 11 26 at any time.12 Severe stomach pain that won't go away can be pancreatitis.1 You can report a side effect to the TGA online or through your GP or pharmacist.13

Questions people ask

Is Mounjaro approved for sleep apnoea in Australia?

Yes. The Australian PI lists moderate to severe obstructive sleep apnoea in adults with obesity as an approved use; newsGP reported it on 4 June 2025.1,2

Is Mounjaro on the PBS for sleep apnoea?

No. Mounjaro is not PBS-subsidised for any use as of October 2026, and we found no PBS application for sleep apnoea.5

Can Mounjaro replace a CPAP machine?

The label doesn't say so. The trials compared tirzepatide with a dummy injection, and one trial kept people on CPAP throughout.1

How much did Mounjaro reduce sleep apnoea?

In the two trials, breathing pauses per hour fell 55% and 63% over 52 weeks, against 5% and 6% on a dummy injection.1

Were people with type 2 diabetes in the sleep apnoea trials?

No. The SURMOUNT-OSA trials excluded people with type 2 diabetes.1

How we researched this

On 12 Oct 2026 we read the Australian Mounjaro PI (version A14.0), newsGP's June 2025 report, the SURMOUNT-OSA trial abstract, healthdirect's sleep apnoea page, the PBS status page for tirzepatide and the PBAC's advice on GLP‑1 obesity treatments.

Trial figures come from the Australian PI; where the published trial differs, we say so. Both trials were paid for by Eli Lilly, which makes Mounjaro. We found no PBS submission for sleep apnoea and no Australian sleep society guidance on combining it with CPAP.

Before you move on

  • Mounjaro is approved for moderate to severe OSA in adults with obesity.
  • Breathing pauses fell by about half or more in 52-week trials.
  • The trials did not compare it with CPAP.
  • It is not PBS-subsidised.
Side effects and risksConsidering it for weightDoctor questions tool

More from the Australia blog

AUAustraliaMounjaro and the PBS: why Lilly said no AUAustraliaWegovy and heart disease: the SELECT trial and the PBS AUAustraliaFatty liver (MASH) and Wegovy in Australia
About GLP Guidebook

The monthly Australia update

An independent guide to GLP‑1 medicines. We don't sell medicines, take drug-company money or earn clinic commissions. Once a month: PBS decisions, TGA approvals, safety notices and recalls. How we write

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Sources

  1. Eli Lilly. Mounjaro (tirzepatide) Australian Product Information, version A14.0, October 2026. medsinfo.com.au Sections 4.1, 4.2, 4.4, 4.5, 4.6, 4.8 (Table 5) and 5.1 (SURMOUNT-OSA, Tables 18 and 19).
  2. newsGP (RACGP). Mounjaro approved to treat sleep apnoea (moderate-to-severe obstructive sleep apnoea in adults living with obesity). 4 June 2025. racgp.org.au
  3. Malhotra A, Grunstein RR, Fietze I et al. Tirzepatide for the treatment of obstructive sleep apnea and obesity (SURMOUNT-OSA). N Engl J Med 2024;391:1193–1205. Funded by Eli Lilly. DOI · PMID 38912654
  4. Healthdirect Australia. Obstructive sleep apnoea (symptoms, overnight sleep study, CPAP, losing weight, oral appliances; higher risk of car and workplace accidents). Last reviewed June 2024. healthdirect.gov.au
  5. Pharmaceutical Benefits Scheme. Medicine status: tirzepatide (Mounjaro), type 2 diabetes ("The pharmaceutical company has advised that it is not proceeding in the PBS listing process at this time"). Information current as at 1 October 2026. pbs.gov.au
  6. Pharmaceutical Benefits Scheme. PBAC advice on equitable access to GLP-1 obesity treatments (priority groups; "a slow and managed roll-out"; "As of February 2026, the Therapeutic Goods Administration (TGA) advises that there are no shortages of any GLP-1 medication in Australia"). pbs.gov.au
  7. Therapeutic Goods Administration. Applying the Advertising Code rules: price information. Updated 21 July 2026. tga.gov.au
  8. Therapeutic Goods Administration. Updated contraception advice for Mounjaro (tirzepatide). Safety update, 1 December 2025. tga.gov.au
  9. Therapeutic Goods Administration. Medicines containing GLP-1 and dual GIP/GLP-1 receptor agonists: new warnings added of risks during anaesthesia or deep sedation. Medicines Safety Update, 3 June 2025. tga.gov.au
  10. Therapeutic Goods Administration. GLP-1 RAs and rare vision disorder (NAION). Medicine Safety Update, 23 July 2026. tga.gov.au
  11. Healthdirect Australia. How healthdirect can help you ("call triple zero (000) for an ambulance immediately"; nurse helpline 1800 022 222, 24 hours a day). healthdirect.gov.au
  12. Healthdirect Australia. Poisoning (Poisons Information Centre, 13 11 26, any time). healthdirect.gov.au
  13. Therapeutic Goods Administration. Reporting adverse events for consumers (online, or through your GP, nurse practitioner, midwife or pharmacist). Updated 2 September 2026. tga.gov.au

Last checked 12 Oct 2026 · Next review due 12 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, nurse or pharmacist before starting, stopping or changing any medicine. How we write