The first medication for obstructive sleep apnea has been approved by the US Food and Drug Administration (FDA).
On December 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 should be paired with a reduced-calorie diet and increased physical activity, the FDA notes.
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Sally Seymour, MD, director of the Division of Pulmonology, Allergy and Critical Care at the FDA’s Center for Drug Evaluation and Research in Washington, DC, applauded the approval at the announcement.
A happy and healthy old man sleeping deeply on his left side without snoring (Stock)
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Seymour wrote. “This is a huge step forward for patients with obstructive sleep apnea.”
OSA occurs when the upper airway becomes blocked and causes shortness of breath during sleep, according to the FDA. This condition is more common in overweight or obese people.
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Similar to semaglutide treatments such as Ozempic and Wegovy, Zepbound activates hormone receptors produced in the gut (GLP-1 and GIP) to reduce appetite and food intake.
About 30 million people suffer from sleep apnea in the US
Studies show that by reducing body weight, Zepbound “also improves OSA,” the FDA noted.
In a 52-week study, participants treated with Zepbound experienced a “statistically significant and clinically meaningful reduction in the incidence of apnea or hypopnea,” and the majority of participants experienced remission or “resolution of symptoms.”
Zepbound improves obstructive sleep apnea by reducing body weight, study shows. (Stock)
Patients treated with Zepbound also reported significant weight loss, the FDA said.
The drug is reported to cause side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, allergic reactions (usually fever and rash), belching, hair loss and gastroesophageal reflux disease.
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Although Zepbound causes thyroid C-cell tumors in mice, it is not known to cause these tumors in humans, so it should not be used in patients with a personal or family history of medullary thyroid cancer or with multiple endocrine neoplasia syndrome type 2, according to the FDA.
The agency encourages all OSA patients to consult a doctor before taking Zepbound and to monitor for any complications.
One sleep expert called the FDA approval “a promising development for millions of people with this condition.” (Stock)
Sleep expert Dr. Wendy Troxel, a senior consultant at the RAND Corporation and a licensed clinical psychologist in Utah, called the FDA’s approval “a promising development for the millions of people who suffer from this condition.”
“Zepbound promotes weight loss and has been shown to reduce apnea events.”
About 30 million people suffer from apnea in the US, Troxel told Fox News Digital.
Although the most common treatment for sleep apnea – positive airway pressure (PAP) – is “very effective” in treating the condition, up to 50% of patients “are not adherent,” he said.
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“Zepbound promotes weight loss and has been shown to reduce apnea events,” notes Troxel.
“For obese people with moderate or severe sleep apnea, this new treatment option may provide an important alternative or adjunctive treatment, especially for those who have difficult to treat apnea, such as positive airway pressure.”
People with a history of severe allergy to tirzepatide should not use Zepbound, the FDA warned in a news release. (Stock)
Troxel added that treating apnea “is important not only for the patient’s health and well-being, but also for their bed partners, who are often the ‘hidden victims’ of untreated apnea, given that loud snoring and gasping are the main ones.” symptoms,” he said.
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Dr. William Lu, medical director of Dream Health in San Francisco, told Fox News Digital that obesity and sleep apnea are “two of the most common health conditions affecting Americans today.”
“We still need to push to change the diet and health habits of many, but this is a good start.”
“And they go hand in hand,” he said. “For patients who are suitable and have no contraindications, tirzepatide has the potential to be a breakthrough drug that can help people lose weight, reduce the severity of sleep apnea and improve overall quality of life.”
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“We still need to push to change the diet and health habits of many, but this is a good start.”
Getting tested for sleep apnea is “important to your health,” Lu says, and may be necessary to get medical help.
Fox News Digital has reached out to Eli Lilly for comment.
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