First-Ever Obstructive Sleep Apnea Drug, Zepbound, Approved by FDA for Obesity

21 December 2024
The FDA has approved tirzepatide (Zepbound) as the first and only medication for obstructive sleep apnea (OSA) in adults with obesity. Clinical trials revealed that tirzepatide achieved an average weight loss of up to 20%, along with a dramatic reduction of at least 25 breathing interruptions per hour. Remarkably, half of these patients no longer exhibited OSA symptoms after one year.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea. This is a major step forward for patients with obstructive sleep apnea,” said Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research.
A Major Step Forward
Eli Lilly and Company announced that the FDA's approval of tirzepatide comes after a series of clinical trials demonstrated significant improvements in obstructive sleep apnea severity and meaningful weight loss among participants. Used alongside a healthy diet and regular physical activity, tirzepatide offers a groundbreaking alternative to existing treatments.
How Zepbound Works
Tirzepatide combines two hormones secreted by the intestine—glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)—to help reduce appetite and food intake. This mechanism has previously shown promise in supporting weight loss for people with obesity. In trials, significant weight reduction correlated with fewer sleep interruptions in patients with OSA.
"Too often, OSA is brushed off as 'just snoring' — but it's far more than that. It's important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes," said Julie Flygare, president and CEO of Project Sleep.
Groundbreaking Clinical Results
The approval is based on two phase 3, randomized, double-blind, placebo-controlled studies known collectively as SURMOUNT-OSA. In total, 469 adults with obesity and moderate-to-severe OSA participated. One study enrolled individuals unable or unwilling to use positive airway pressure (PAP) therapy, while the other study included adults who continued using PAP throughout the trial.
- Reduced Breathing Interruptions: Participants not on PAP therapy reduced their breathing interruptions (apnea or shallow breathing) by 25 events per hour on average with Zepbound, compared to just 5 events per hour with a placebo. In those on PAP therapy, the reduction was 29 events per hour for Zepbound vs 6 per hour for placebo.
- Alleviation of OSA Symptoms: Nearly half of participants receiving Zepbound (42% without PAP and 50% with PAP) achieved remission or only mild, non-symptomatic OSA by the end of the 52-week study period, compared to 16% and 14% of those on placebo, respectively.
- Significant Weight Loss: Adults taking Zepbound without PAP therapy lost an average of 45 lbs (18% of their body weight), while those on PAP therapy lost around 50 lbs (20% of their body weight). By contrast, those in the placebo groups lost only 4 lbs (2%) or 6 lbs (2%), depending on PAP use.
"Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges," said Patrik Jonsson, EVP and President of Lilly USA.
Obstructive sleep apnea occurs when a person’s upper airway becomes blocked during sleep. While this can affect individuals of any body size, it is most frequently seen in people who have overweight or obesity. The condition is commonly underdiagnosed, in part because its main signs—snoring, daytime sleepiness, and fatigue—are often overlooked.
A New Era for OSA Management
Experts are hailing Zepbound’s FDA approval as a game-changing advance in the management of moderate-to-severe obstructive sleep apnea. This innovative therapy offers an alternative for adults with obesity who either cannot or choose not to use PAP therapy, or who may require additional support to achieve sustained weight loss and relieve OSA symptoms.
Usage and Safety Information
Zepbound is designed for long-term use alongside a reduced-calorie diet and increased physical activity. It should not be combined with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. Research has not yet determined its safety or efficacy in children.
Key Warnings and Precautions:
- Thyroid C-cell Tumors: Zepbound has been associated with thyroid tumors in animal studies. Patients with a personal or family history of medullary thyroid carcinoma (MTC) or with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should avoid using this medication.
- Serious Allergic Reactions: Individuals who have had severe allergic reactions to tirzepatide or any ingredient in Zepbound should not use it.
- Gastrointestinal Side Effects: The most common adverse events include nausea, diarrhea, vomiting, constipation, abdominal pain, and indigestion. Severe gastrointestinal issues should be reported to a healthcare provider.
- Other Risks: Zepbound carries warnings about pancreatitis, gallbladder problems, hypoglycemia (especially if used with insulin or certain diabetes medications), and kidney injury. In patients with type 2 diabetes, there is also a caution regarding diabetic retinopathy (damage to the eye’s retina), and healthcare providers are advised to monitor patients for suicidal thoughts or behaviors.
Patients considering Zepbound should discuss their complete medical history with a healthcare provider to evaluate the risks and benefits of this new treatment.
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