FDA approves Zepbound for sleep apnea, the first drug cleared for the condition

The FDA on December 20, 2024 approved Zepbound (tirzepatide) for moderate-to-severe obstructive sleep apnea in adults with obesity, the first medication ever cleared to treat the sleep disorder ^[1]. Eli Lilly makes the drug, which is meant to be used with a reduced-calorie diet and more physical activity ^[1]. Tirzepatide is also sold under the brand name Mounjaro ^[3].

Obstructive sleep apnea happens when the upper airway becomes blocked during sleep, causing breathing to stop and start ^[1]. The condition is more common in people with overweight or obesity, and Lilly says many cases go undiagnosed and untreated ^[1][2].

"This is a major step forward for patients with obstructive sleep apnea," said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Center for Drug Evaluation and Research, who called it the first drug treatment option for certain patients with the condition ^[1].

What the studies showed

Two randomized, double-blind, placebo-controlled trials supported the decision, enrolling 469 adults without type 2 diabetes between them ^[1]. One study included people using positive airway pressure (PAP) therapy, the standard of care; the other included people unable or unwilling to use PAP ^[1]. Participants received Zepbound at 10 mg or 15 mg, or a 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]. In both trials, Zepbound produced a statistically significant and clinically meaningful reduction in AHI events compared with placebo, and larger shares of treated participants reached remission or mild OSA with symptoms resolved ^[1]. The FDA said the AHI improvement is likely related to weight loss ^[1].

Lilly reported that in the group not using PAP, Zepbound reduced breathing disruptions by about 25 per hour, versus five per hour with placebo, roughly five times the placebo effect. In the PAP group, the reduction was 29 per hour with Zepbound versus six with placebo ^[2]. After one year, 42% of participants taking Zepbound alone and 50% of those taking it with PAP no longer had symptoms associated with OSA, compared with 16% and 14% on placebo ^[2].

Average weight loss was 45 pounds (18%) without PAP and 50 pounds (20%) with PAP, compared with 4 pounds (2%) and 6 pounds (2%) in the placebo groups ^[2].

Reported side effects include nausea, diarrhea, vomiting, constipation, stomach discomfort and pain, injection site reactions, fatigue, allergic reactions, burping, hair loss and gastroesophageal reflux disease ^[1][6]. A boxed warning says tirzepatide causes thyroid C-cell tumors in rats and that it is unknown whether it does so in humans; the drug is not for people with a personal or family history of medullary thyroid cancer or with Multiple Endocrine Neoplasia syndrome type 2 ^[1][6]. Other labeled warnings cover pancreatitis, gallbladder problems, low blood sugar, acute kidney injury, diabetic retinopathy in people with type 2 diabetes, and food or liquid entering the lungs during anesthesia or deep sedation ^[1]. The FDA's 2024 announcement also listed suicidal behavior or thinking as a warning, while the current prescribing information lists that warning as removed in February 2026 ^[1][6].

Why it matters for patients

Until now, moderate-to-severe sleep apnea was handled mainly with devices and procedures rather than drugs. PAP therapy is usually the first treatment offered, and other options exist for people who cannot use it ^[4]. Zepbound adds a medication route for adults whose sleep apnea comes with obesity, and it is also approved separately for weight reduction in adults with obesity or overweight plus at least one weight-related condition ^[2][6].

Insurance rules shift with the new indication. State Medicaid programs must cover nearly all FDA-approved drugs for medically accepted uses, but weight-loss drugs are an exception states may skip. Because Zepbound is now approved for sleep apnea, coverage for that use is required, while coverage for obesity alone stays optional; 13 state Medicaid programs covered GLP-1s for obesity under fee-for-service as of January 2026 ^[3].

For people on Medicare, Zepbound falls under Part D, which does not cover it for weight loss alone. Some plans cover it for sleep apnea when a sleep study confirms the diagnosis and the patient meets weight criteria, and prior authorization is often required ^[4]. In 2025, Part D's $2,000 annual cap applied to covered prescriptions ^[4].

What happens next

An agreement between Lilly and the U.S. government is set to lower costs for Medicare recipients, tentatively to as little as a $50 monthly copay beginning in April 2026 once a deductible is met ^[4]. A separate Medicare Part D demonstration is scheduled to open obesity drug access in July 2026, and a voluntary model called BALANCE is expected to begin in May 2026 ^[3].

The label lists 10 mg or 15 mg once weekly as the maintenance dose for sleep apnea, and says Zepbound should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist; its safety and effectiveness in children is not known ^[2][6]. The FDA granted the approval to Eli Lilly and Co. and gave the application Fast Track, Priority Review and Breakthrough Therapy designations ^[1].