FDA approves first medication for obstructive sleep apnea, which also promotes weight loss
The first medication for obstructive sleep apnea has been approved by the U.S. Food and Drug Administration (FDA).
On Dec. 20, the FDA announced that the agency has approved Eli Lilly's Zepbound (tirzepatide) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity.
The drug is to be paired with a reduced-calorie diet and increased physical activity, the FDA noted.
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Sally Seymour, M.D., director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research in Washington, D.C., applauded the approval in an announcement.
"Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea," Seymour wrote. "This is a major step forward for patients with obstructive sleep apnea."
OSA occurs when the upper airway becomes blocked and causes pauses in breathing during sleep, according to the FDA. The condition is more common in people who are overweight or obese.
Similar to semaglutide treatments like Ozempic and Wegovy, Zepbound activates receptors of hormones secreted from the intestine (GLP-1 and GIP) to reduce appetite and food intake.
Studies show that by reducing body weight, Zepbound "also improves OSA," the FDA noted.
In a 52-week study, participants treated with Zepbound experienced "statistically significant and clinically meaningful reduction in events of apnea or hypopnea," and a large share of participants achieved remission or "resolution of symptoms."
Zepbound-treated patients also reported a significant decrease in body weight, the FDA mentioned.
The drug can reportedly cause side effects like nausea, diarrhea, vomiting, constipation, stomach discomfort and pain, injection site reactions, fatigue, allergic reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease.
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While Zepbound causes thyroid C-cell tumors in rats, it’s unknown whether it causes these tumors in humans, so it should not be used by patients with a personal or family history of medullary thyroid cancer or with multiple endocrine neoplasia syndrome type 2, per the FDA.
The agency encourages all OSA patients to consult with a doctor before taking Zepbound and to monitor for any complications.
Sleep expert Dr. Wendy Troxel, who is a RAND Corporation senior behavioral specialist and licensed clinical psychologist in Utah, called the FDA’s approval a "promising advancement for the millions of people who suffer from this condition."
About 30 million people suffer from sleep apnea in the U.S., Troxel told Fox News Digital.
While the most common treatment for sleep apnea — positive airway pressure (PAP) — is "highly effective" at treating the condition, up to 50% of patients are "non-adherent," she said.
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"Zepbound promotes weight loss and has been shown to reduce apnea events," Troxel noted.
"For obese individuals with moderate to severe sleep apnea, this new treatment option may offer an important alternative or adjunctive treatment, particularly for those who struggle with sleep apnea therapies, such as positive airway pressure."
Troxel added that treating sleep apnea is "critical not only for the patient’s health and well-being, but also for their bed partners, who are often the ‘hidden casualties’ of untreated sleep apnea, given that loud snoring and gasping for air are primary symptoms," she said.
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Dr. William Lu, medical director of Dreem Health in San Francisco, told Fox News Digital that obesity and sleep apnea are "two of the most prevalent health conditions that affect Americans today."
"And they go hand in hand," he said. "For the patients who qualify and have no contraindications, tirzepatide has the opportunity to be a generational medication that can help people lose weight, reduce the severity of sleep apnea and improve overall health."
"We still need to emphasize shifting the diet and health habits of many, but this is a fantastic start."
Getting tested for sleep apnea is "critical for your health," Lu said, and could also be a requirement for getting coverage for the medication.
Fox News Digital reached out to Eli Lilly requesting comment.