Zepbound for sleep apnea: what the label and the SURMOUNT-OSA trials report

A weight-loss medicine with a sleep medicine indication

Most readers meet tirzepatide as a weight-management drug. But the Zepbound label has two separate indications: to reduce excess body weight and maintain weight reduction in adults with obesity or with overweight and a weight-related condition, and to treat moderate to severe obstructive sleep apnea in adults with obesity. That second indication changes the conversation in a sleep clinic and, depending on the plan, in a coverage review. We have not found it covered in detail elsewhere on this site, so this guide sets out exactly what the label and the trial publication say, and where they stop.

We read the full Zepbound label (revised 08/2026) on 14 October 2026, including sections 1, 2.2, 6.1 and 14.2, the New England Journal of Medicine report of the trials as indexed on PubMed, and the ClinicalTrials.gov record. Numbers below come from those documents. Obstructive sleep apnea is a diagnosed medical condition, and nothing here is guidance on diagnosing or treating it.

What the label says

Section 1 of the Zepbound label states that Zepbound is indicated in combination with a reduced-calorie diet and increased physical activity to treat moderate to severe OSA in adults with obesity. The dosing section lists a maintenance dose for OSA of 10 mg or 15 mg injected subcutaneously once weekly, reached through the same dose escalation schedule used for weight management. The Limitations of Use section says that coadministration with other tirzepatide-containing products or any other GLP-1 receptor agonist is not recommended.

Two details are easy to miss. First, the OSA indication is for adults with obesity; it is not written for OSA in people without obesity. Second, the label identifies moderate to severe OSA, which the trials defined by an apnea-hypopnea index of 15 or more events per hour on a sleep study.

The two trials behind the indication

Section 14.2 of the label describes Study 5 and Study 6, a master-protocol program (NCT05412004) published as SURMOUNT-OSA. Together they randomized 469 adults with moderate to severe OSA and obesity (BMI of 30 or more) 1:1 to the maximum tolerated dose of Zepbound (10 mg or 15 mg) or placebo for 52 weeks, with dose escalation over up to 20 weeks. Adults with type 2 diabetes were excluded, and everyone received reduced-calorie diet and physical activity counseling.

	Study 5	Study 6
Who enrolled	234 adults unable or unwilling to use PAP therapy	235 adults already on PAP therapy
Mean baseline AHI (events/hour)	51.5	49.5
Mean baseline BMI	39.1	38.7
Share with severe OSA (AHI of 30 or more)	63.1%	68.2%

Study 6 participants were instructed to suspend PAP for 7 days before the primary endpoint assessment. The label states plainly that the studies did not evaluate the timing or appropriateness of PAP discontinuation in patients who were previously compliant with PAP. In other words, the label gives no basis for a patient to stop CPAP on their own.

What the results were

The primary endpoint was the change in AHI from baseline at week 52. Table 9 of the label and the NEJM abstract report the same figures:

Week 52 result	Study 5: placebo	Study 5: Zepbound	Study 6: placebo	Study 6: Zepbound
Mean AHI change (events/hour)	-5.3	-25.3	-5.5	-29.3
Difference vs. placebo (95% CI)		-20.0 (-25.8 to -14.2)		-23.8 (-29.6 to -17.9)
Patients with at least a 50% AHI reduction	19%	61.2%	23.3%	72.4%
Remission or mild non-symptomatic OSA (label definition)	15.9%	42.2%	14.3%	50.2%
Body weight change	-1.6%	-17.7%	-2.3%	-19.6%

The label also reports reductions in sleep apnea-specific hypoxic burden and, compared with placebo, greater reductions in systolic blood pressure and high-sensitivity C-reactive protein in both studies, and says AHI reductions were seen irrespective of age, sex, ethnicity, baseline BMI or baseline OSA severity. The NEJM report lists the same set of key secondary outcomes, plus improvements in patient-reported sleep impairment and disturbance.

Two cautions are worth holding onto. Both trials were funded by the manufacturer, which is disclosed in the publication. And the weight loss in these studies was large, so the AHI improvement cannot be separated from the weight change using the label; the NEJM authors describe excess adiposity as an etiologic risk factor, and we do not attribute the effect to anything beyond what the trials measured.

How to read the numbers

The apnea-hypopnea index counts breathing pauses and shallow breaths per hour of sleep. The label defines moderate OSA in these studies as an AHI of 15 to under 30 events per hour and severe OSA as 30 or more. Baseline AHI averaged about 50 events per hour, so a fall of 25 to 29 events per hour is large in absolute terms, but participants on average still had some residual events. The label’s “remission or mild non-symptomatic OSA” category is defined as an AHI under 5, or an AHI of 5 to 14 with an Epworth Sleepiness Score of 10 or less. That category was reached by 42.2% of Study 5 and 50.2% of Study 6 patients on Zepbound, which also means a majority in Study 5 and about half in Study 6 did not reach it.

Another way to see the same data is the share with at least a 50% fall in AHI: 61.2% and 72.4% on Zepbound versus 19% and 23.3% on placebo. Placebo participants improved a little too, which the trial design is built to account for, since all participants received diet and activity counseling. The trials lasted 52 weeks; the label does not report what happens to AHI after treatment stops, and we do not guess.

Safety in the sleep apnea trials

Section 6.1 of the label says Zepbound was evaluated in 467 adults with moderate to severe OSA and obesity in these two trials, and that the adverse reactions seen with 10 mg or 15 mg once weekly were similar to those in the pooled weight-reduction trials. The NEJM abstract states that the most frequent adverse events were gastrointestinal and mostly mild to moderate. The full warnings apply to OSA patients as to anyone else on the drug, including pancreatitis, gallbladder disease, acute kidney injury from volume depletion, hypersensitivity and pulmonary aspiration during anesthesia. We have covered those one by one: see pancreatitis on GLP-1 labels, gallbladder and gallstones, dehydration and kidney injury and GLP-1 medicines before surgery and anesthesia, which is directly relevant because many sleep apnea patients have procedures that involve sedation.

The label also tells patients using oral hormonal contraceptives to switch to a non-oral method or add a barrier method for 4 weeks after starting Zepbound and for 4 weeks after each dose escalation; our guide to contraception and pregnancy on GLP-1 labels explains this in full.

How this fits with getting the medicine

An approved indication does not guarantee coverage, and we are not publishing any coverage or price claims in this article because we did not verify a plan’s rules. What we can say from the label is that the OSA indication is a different use from weight management, so a prior authorization or appeal may be framed around a sleep study diagnosis; our walkthrough of GLP-1 prior authorization and appeals covers how those requests usually work. For a view of plans that take insurance, see GLP-1 providers that accept insurance, and for brand-name prescribing through telehealth, brand-name GLP-1 telehealth providers. The manufacturer’s own routes are collected under official GLP-1 manufacturer programs, and the side-by-side drug view is on our Ozempic vs. Wegovy vs. Zepbound comparison. These are editorial resources, not recommendations.

What to ask a clinician

• Has the OSA been confirmed by a sleep study, and is it moderate to severe (AHI of 15 or more)?
• If I use CPAP now, who decides whether my therapy changes, and what follow-up sleep testing would guide that?
• The trials excluded people with type 2 diabetes; does that affect how my situation is read?
• I have an upcoming procedure involving sedation; what is the plan for the medicine around it?

Frequently asked questions

Is Zepbound approved for sleep apnea?

Yes, for moderate to severe obstructive sleep apnea in adults with obesity, per section 1 of the current label (revised 08/2026).

What dose does the label list for sleep apnea?

10 mg or 15 mg injected subcutaneously once weekly, after dose escalation.

Can I stop CPAP if I start it?

The label says the studies did not evaluate the timing or appropriateness of stopping PAP therapy. That is a decision for your sleep clinician.

Does this apply to the other GLP-1 medicines?

The sleep apnea indication appears on the Zepbound label. The Wegovy label we read for this series lists cardiovascular risk reduction, weight reduction and a liver indication, but no sleep apnea indication.

Medical disclaimer. This article is informational, was prepared by the GLP-1.Reviews editorial team from the public sources listed above, and has not been reviewed by a physician. It is not medical advice. Label wording can change; confirm the instructions for your product with the Medication Guide that came with it. Talk to your prescriber or pharmacist about your own treatment, and see our medical disclaimer and editorial standards.

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