The first medicine approved for sleep apnea
Zepbound (tirzepatide) was approved in December 2024 for moderate to severe obstructive sleep apnea in adults with obesity, used alongside a reduced-calorie diet and increased physical activity. It is not a replacement for CPAP.
What it is approved for
On 20 December 2024 the FDA approved Zepbound, tirzepatide, for moderate to severe obstructive sleep apnea in adults with obesity. It was the first medicine ever approved to treat sleep apnea.
The labelled indication is in combination with a reduced-calorie diet and increased physical activity. That phrase is part of the indication, not a footnote to it. The medicine is approved as one component of a programme, not on its own.
It is not a replacement for CPAP
This needs saying plainly, because it is the most common misreading and the one with the most at stake.
One of the two pivotal studies enrolled people who were using positive airway pressure and kept them on it. The prescribing information states explicitly that the trials did not evaluate the timing or appropriateness of stopping positive airway pressure in people who were previously using it. Nothing in the label instructs anyone to stop.
If you are on CPAP and considering this medicine, the question of what happens to your CPAP is a clinical decision for your physician, taken after treatment and on the evidence of a repeat study. It is not something the approval answers.
What the trials showed
The SURMOUNT-OSA programme ran two 52-week randomised, double-blind, placebo-controlled studies. Everyone in both, including the placebo groups, received diet and activity counselling.
| Outcome | Not using PAP | Using PAP |
|---|---|---|
| Participants | 234 | 235 |
| Change in events per hour, tirzepatide | −25.3 | −29.3 |
| Change in events per hour, placebo | −5.3 | −5.5 |
| Reached remission or mild, non-symptomatic apnea | 42.2% | 50.2% |
| Same, on placebo | 15.9% | 14.3% |
| Change in body weight | −17.7% | −19.6% |
Those are substantial results. They are also not a cure: average residual breathing events were not zero in either treated group, and the trials enrolled people with a body mass index of 30 or above and at least 15 events an hour.
How it is taken
It is a once-weekly injection under the skin. Treatment starts at 2.5 mg weekly for four weeks, which is an initiation dose and not a maintenance dose, then increases in 2.5 mg steps with at least four weeks at each step. For sleep apnea the maintenance dose is 10 mg or 15 mg once weekly, and 15 mg is the maximum for any indication. It should not be combined with other tirzepatide products or with a GLP-1 receptor agonist.
Insurance
Medicare Part D excludes drugs used for weight loss. The sleep apnea indication is a separate labelled use and may be covered by a given Part D formulary, generally with prior authorisation. That is plan by plan. We cannot tell you Medicare covers this, because as a national rule it does not.
Commercial plans commonly require prior authorisation, and some that exclude weight-loss drugs may still consider the sleep apnea indication.
Considering this instead of your machine?
Bring that question to the appointment. It is a reasonable thing to ask and a bad thing to decide alone.
Call (614) 898-9340Sources
- AASM: Zepbound approved by FDA as first sleep apnea medication. https://aasm.org/zepbound-approved-fda-first-sleep-apnea-medication/
- Zepbound prescribing information, Eli Lilly. https://pi.lilly.com/us/zepbound-uspi.pdf
- Malhotra A et al. Tirzepatide for the treatment of obstructive sleep apnea and obesity. N Engl J Med 2024. https://www.nejm.org/doi/abs/10.1056/NEJMoa2404881