Mount Sinai’s Mira Tadros, DO, was in the midst of developing a new sleep obesity program when her efforts received a significant boost from the U.S. Food and Drug Administration (FDA).
In December 2024, the agency announced the approval of tirzepatide (Zepbound®), a dual glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor (GLP-1) agonist indicated as a treatment for moderate to severe obstructive sleep apnea (OSA) among adults with obesity.
“I am board certified in internal medicine and recently completed the American Board of Obesity Medicine certification training, and was reaching out to different departments to get the program up and running,” says Dr. Tadros, Assistant Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine) at the Icahn School of Medicine at Mount Sinai. “This approval is welcome because it will expedite the availability of novel treatments for sleep apnea that will be useful in obese patients.”
Scheduled to launch in March 2025, Dr. Tadros’s program will take a holistic, multidisciplinary approach to managing OSA among patients with obesity. It is a timely undertaking. According to Centers for Disease Control and Prevention data released in 2024, more than one in three adults (35 percent) in 23 states are obese—a notable development given that no state had an adult obesity prevalence at or above 35 percent 10 years prior. Obesity is a major risk factor for OSA; Dr. Tadros notes that approximately 40 percent of patients with a body mass index greater than 30 kg/m2 present with OSA, and that figure rises to 90 percent among individuals who are referred for bariatric surgery. Additionally, having untreated OSA can make it difficult to lose weight.
“In my four years of sleep medicine practice, I found it challenging to effectively manage obesity, which is a major risk factor for OSA,” says Dr. Tadros, who is board certified in sleep medicine. “I became interested in learning more about obesity management and sought board certification. That double board certification makes this program unique because it gives me unique insights on the pathophysiology and management of comorbid obesity and sleep disorders.”
Dr. Tadros is working to address the biggest challenge in obesity-related obstructive sleep apnea: a shortage of treatment options.
Although the dual certification is advantageous, Dr. Tadros explains that the biggest challenge in managing obesity-related OSA is a shortage of treatment options. She says data on continuous positive airway pressure (CPAP) therapy—the gold standard for sleep apnea—showed that while it treats OSA with significant improvement in daytime sleepiness, its impact on weight is not always favorable. Meanwhile, alternative options have their limitations. Oral appliances have variable efficacy, and ENT interventions such as surgery and hypoglossal nerve stimulation are invasive and thus have limited appeal among patients.
The FDA approval of tirzepatide, the first drug approved for OSA treatment, helps fill this gap in treatment options. Dr. Tadros says that participants in the SURMOUNT-4 randomized clinical trial, which assessed the therapeutic agent’s efficacy, experienced a mean weight reduction of up to 17 percent compared to placebo, and halved patients’ AHI (measure of sleep apnea severity) compared to placebo, which is clinically significant.
“We have Mount Sinai patients with OSA who have been administered tirzepatide by their endocrinologists for weight loss and diabetes,” Dr. Tadros says. “In some cases, we have seen significant reduction in their sleep apnea when we have done retesting. It is exciting now that, with the FDA approval, we can increase access to this medication among our patients.”
Dr. Tadros says patients referred to the program will undergo extensive assessment to determine their suitability for tirzepatide treatment. The selection criteria include presenting symptoms, severity of sleep apnea, review of contraindications—such as a family history of medullary thyroid cancer and multiple endocrine neoplasia syndrome type 2—and the patient’s goals. Those who are approved for treatment will be monitored for tolerance and outcomes. They will also get nutritional counseling to help them adjust their dietary habits to assist with weight loss, as well as counseling on increasing physical activity and exercise to maintain their weight loss and general fitness. All these interventions are aimed at optimizing both the quality and duration of sleep and weight loss.
Dr. Tadros is finalizing program logistics and continuing outreach to departments and physicians to engage patients who would benefit from enrollment and access to tirzepatide. She is also exploring opportunities to participate in clinical trials for emerging therapeutic agents that have shown promise in treating OSA among patients with obesity.
“I think tirzepatide is just the beginning,” Dr. Tadros says. “There are a lot of other medications that are being investigated for sleep apnea, and I want to ensure our patients have access to them."