In a major development, the first drug treatment option for certain patients with obstructive sleep apnea (OSA) is now available with the United States Food and Drug Administration (FDA) approving Zepbound (tirzepatide) for the treatment of moderate to severe OSA (OSA) in adults with obesity. The  medicine is to be used alongside a reduced-calorie diet and increased physical activity.

"Today's approval marks the first drug treatment option for certain patients with obstructive sleep apnea," said Sally Seymour, MD, director of the Division of Pulmonology, Allergy, and Critical Care in the FDA's Centre for Drug Evaluation and Research. "This is a major step forward for patients with obstructive sleep apnea."

OSA is a condition in which the upper airway becomes blocked during sleep, leading to pauses in breathing. It is more common in individuals with overweight or obesity. Zepbound works by activating receptors of specific intestinal hormones (GLP-1 and GIP), reducing appetite and food intake, which leads to body weight reduction. Studies indicate that this weight loss improves OSA symptoms.

Clinical trials demonstrate efficacy

Zepbound's approval is based on two clinical trials involving 469 adults without type 2 diabetes. The trials, conducted over 52 weeks, assessed the drug's impact on the apnea-hypopnea index (AHI), which measures the frequency of apnea (breathing stops) or hypopnea (shallow breathing) episodes per hour during sleep.

Key findings from the trials include:

* Participants treated with Zepbound experienced a statistically significant reduction in AHI compared to the placebo group.

* Higher proportions of Zepbound users achieved remission or mild OSA with symptom resolution compared to placebo.

* Participants taking Zepbound showed a significant decrease in body weight, likely contributing to the improvement in OSA.

Potential side effects and warnings

While Zepbound offers a promising solution, it is not without risks. Common side effects include gastrointestinal issues like Nausea, diarrhea, vomiting, constipation, and abdominal discomfort. Other reactions include injection site reactions, fatigue, hair loss, hypersensitivity, and gastroesophageal reflux disease. In extreme cases, patients risk thyroid C-cell tumors, pancreatitis, gallbladder issues, and kidney injury, hypoglycemia, depression and suicidal behaviours.

Zepbound is contraindicated for individuals with a personal or family history of medullary thyroid cancer, Multiple Endocrine Neoplasia syndrome type 2, or severe allergic reactions to tirzepatide.

Patients are advised to discuss their medical history with health care providers to evaluate Zepbound's suitability. Providers should monitor patients with pre-existing conditions like kidney disease, diabetic retinopathy, and depression, and adjust treatments as necessary.