FDA Approves Tirzepatide as First Drug Treatment for Obstructive Sleep Apnea in Adults With Obesity

On December 20, the FDA approved tirzepatide for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity - the first drug approved to specifically address OSA. Intended for use alongside a reduced-calorie diet and increased physical activity, tirzepatide provides a new therapeutic option for patients with OSA.

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Sally Seymour, MD, Director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a press release. “This is a major step forward for patients with obstructive sleep apnea.”

Obstructive sleep apnea is a common sleep disorder characterized by repetitive episodes of blocked airflow during sleep, resulting in breathing interruptions, which can lead to daytime fatigue, cardiovascular complications, and other health issues. While the condition can affect individuals of any body type, it is most prevalent among people with overweight or obesity. Until now, treatment options primarily included lifestyle changes, weight loss, and mechanical interventions such as positive airway pressure (PAP) therapy, which many patients find challenging to use consistently.

Tirzepatide is a once-weekly injectable medication that works by activating receptors for glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide, hormones involved in appetite regulation. By reducing appetite and food intake, tirzepatide facilitates weight loss, which is a crucial factor in improving OSA severity.

The FDA's approval is based on data from two randomized, double-blind, placebo-controlled trials involving 469 adults without type 2 diabetes. Participants were split into two groups: one receiving standard PAP therapy and another unable or unwilling to use PAP. Each group was further randomized to receive tirzepatide (10 or 15 mg) or placebo weekly for 52 weeks.

The trials evaluated changes in the apnea-hypopnea index (AHI), which measures the frequency of breathing interruptions during sleep. Results demonstrated a statistically significant reduction in AHI among tirzepatide recipients compared with placebo. Additionally, a higher proportion of patients treated with tirzepatide achieved remission or mild OSA with symptom resolution. These outcomes were strongly linked to substantial weight loss achieved with the medication.

Common reactions for tirzepatide include nausea, diarrhea, constipation, and abdominal discomfort. Rare but serious risks include thyroid tumors in animal studies, pancreatitis, gallbladder issues, and hypoglycemia. Patients with a history of medullary thyroid cancer, multiple endocrine neoplasia syndrome type 2, or severe allergic reactions to tirzepatide should avoid tirzepatide. The FDA also advises health care providers to monitor for complications such as depression, diabetic retinopathy, and acute kidney injury.

Reference
FDA Approves First Medication for Obstructive Sleep Apnea. US Food and Drug Administration. December 20, 2024. Accessed December 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea.