From the labelZepbound is indicated “to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity,” together with a reduced-calorie diet and increased physical activity.[1] The FDA called it the first medication approved for OSA.[2]
The OSA dose schedule
Start at 2.5 mg once weekly for 4 weeks, go to 5 mg, then increase in 2.5 mg steps after at least 4 weeks on each dose. The recommended maintenance dose for OSA is “10 mg or 15 mg injected subcutaneously once weekly.”[1]
- 2.5 mgWeeks 1–4 · starting dose
- 5 mgFrom week 5 at the earliest
- 7.5 mgFrom week 9 at the earliest
- 10 mgFrom week 13 at the earliest
- 12.5 mgFrom week 17 at the earliest
- 15 mgFrom week 21 at the earliest · maximum
At the fastest pace the label allows, 10 mg can begin in week 13 and 15 mg in week 21. 5 and 7.5 mg are steps on the way, not OSA maintenance doses.[1]
SURMOUNT-OSA results
Two 52-week trials gave tirzepatide at the maximum tolerated dose (10 or 15 mg) or placebo. Trial 1 enrolled people not using positive airway pressure (PAP); trial 2 enrolled people on PAP. Participants had an apnea-hypopnea index (AHI) of at least 15 and a BMI of at least 30; average AHI at the start was about 50 events per hour.[3][1]
- −25.3AHI events/hour, trial 1 (placebo −5.3)
- −29.3AHI events/hour, trial 2 on PAP (placebo −5.5)
- −17.7%body weight, trial 1 (placebo −1.6%)
| Outcome | Trial 1 (no PAP) | Trial 2 (on PAP) |
|---|---|---|
| AHI change, events per hour | −25.3 vs −5.3 | −29.3 vs −5.5 |
| Difference from placebo | −20.0 | −23.8 |
| AHI change, % (label) | −50.7% vs −3.0% | −58.7% vs −2.5% |
| Remission or mild non-symptomatic OSA (label) | 42.2% vs 15.9% | 50.2% vs 14.3% |
| Body weight change (label) | −17.7% vs −1.6% | −19.6% vs −2.3% |
Event counts are from the NEJM paper; percentages are from the Zepbound label.[3][1] The label reports that side effects in the OSA trials were similar to those in the weight trials.[1]
Dose math
For OSA the doses are the same strengths as for weight, so the same fixed volumes apply: 0.5 mL from a single-dose pen or vial, 0.6 mL from a multi-dose vial or KwikPen.[1] See 10 mg in units and 15 mg in units.
Related
Frequently asked questions
What dose of Zepbound is used for sleep apnea?
The label's maintenance dose for OSA is 10 mg or 15 mg once weekly, reached by the usual climb from 2.5 mg.[1]
Does Zepbound replace a CPAP machine?
The label does not say so. One of the two trials enrolled people who kept using PAP throughout.[3] Ask your sleep specialist.
Sources
- Zepbound (tirzepatide) injection: prescribing information, Medication Guide and Instructions for Use
- FDA approves first medication for obstructive sleep apnea
- Malhotra A et al. Tirzepatide for the treatment of obstructive sleep apnea and obesity (SURMOUNT-OSA)
- Drugs@FDA: NDA 217806 (Zepbound) approval history and supplement letters