FDA approves Zepbound for obstructive sleep apnea

The U.S. Food and Drug Administration approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used along with a reduced-calorie diet and increased physical activity ^[1]. The agency called it "the first drug treatment option for certain patients with obstructive sleep apnea," in a statement from Sally Seymour, M.D., director of the FDA's Division of Pulmonology, Allergy, and Critical Care ^[1].

OSA happens when the upper airway becomes blocked during sleep, causing pauses in breathing. It is more common in people with overweight or obesity ^[1]. Zepbound activates receptors for two gut hormones — GLP-1 and GIP — to reduce appetite and food intake, and the FDA said the improvement in sleep apnea seen in trials is likely related to the weight loss the drug produces ^[1].

What the trials showed

The approval rests on two randomized, double-blind, placebo-controlled studies known as SURMOUNT-OSA, which together enrolled 469 adults without type 2 diabetes ^[1][2]. One study enrolled people already using positive airway pressure (PAP) therapy, the standard of care; the other enrolled people unable or unwilling to use PAP ^[1]. Participants received either 10 mg or 15 mg of Zepbound or placebo once weekly for 52 weeks ^[1].

The main measure was change in the apnea-hypopnea index (AHI), which counts how many times per hour a person stops breathing or breathes shallowly during sleep ^[1]. Among adults not using PAP, Zepbound led to 25 fewer breathing disruptions per hour, compared with five on placebo ^[2]. Among those on PAP, Zepbound produced 29 fewer disruptions per hour versus six on placebo ^[2].

After one year, 42% of adults on Zepbound alone and 50% of those on Zepbound plus PAP reached remission or mild, non-symptomatic OSA, compared with 16% and 14% on placebo, respectively ^[2]. Weight loss averaged 45 pounds (18%) in the no-PAP group and 50 pounds (20%) in the PAP group, versus 4 pounds (2%) and 6 pounds (2%) on placebo ^[2].

Dosing for the OSA indication is narrower than for weight management. The prescribing information lists a maintenance dose of 10 mg or 15 mg once weekly for obstructive sleep apnea, versus 5 mg, 10 mg, or 15 mg for weight reduction, with a starting dose of 2.5 mg weekly and increases in 2.5 mg steps no sooner than every four weeks ^[6].

Zepbound's known risks carried over to this indication. The FDA lists nausea, diarrhea, vomiting, constipation, abdominal pain, injection site reactions, fatigue, allergic reactions, burping, hair loss and reflux among side effects, plus warnings for pancreatitis, gallbladder problems, low blood sugar, acute kidney injury, diabetic retinopathy in people with type 2 diabetes, and pulmonary aspiration during anesthesia ^[1]. The drug carries a boxed warning about thyroid C-cell tumors seen in rats and is contraindicated in people with a personal or family history of medullary thyroid carcinoma or MEN 2 ^[1][6]. The OSA application received Fast Track, Priority Review and Breakthrough Therapy designations ^[1].

Why it matters for patients

The practical significance is largely about coverage. Under the Medicaid Drug Rebate Program, states may exclude weight-loss drugs, but coverage is required for drugs approved for other indications — and since the December 2024 decision, that includes Zepbound for moderate to severe OSA in adults with obesity ^[3]. As of January 2026, only 13 state Medicaid programs covered GLP-1s for obesity treatment under fee-for-service ^[3].

Medicare works differently. Medicare Part D does not currently cover Zepbound for weight loss alone, but some plans cover it for obstructive sleep apnea when the condition is weight-related, typically with prior authorization and a diagnosis confirmed by a sleep study or home sleep apnea test ^[4]. Formularies vary by plan ^[4].

The approval does not displace PAP therapy, which the FDA describes as the standard of care for moderate to severe OSA ^[1]. One of the two trials tested Zepbound in people who stayed on PAP throughout ^[2].

The prevalence figure sometimes attributed to Lilly — roughly 20 million U.S. adults with moderate-to-severe OSA — does not appear in the FDA or Lilly materials reviewed here, so that number is not confirmed by these sources.