The U.S. Food and Drug Administration has approved Eli Lilly’s weight loss drug Zepbound to treat moderate-to-severe obstructive sleep apnea in adults with obesity.
FDA Approval and Clinical Trial Results
The U.S. Food and Drug Administration authorized the use of Zepbound, made by Eli Lilly & Co., for adults with obesity and moderate to severe obstructive sleep apnea (OSA), a common condition where a person struggles to breathe properly during sleep. The federal agency advises that the drug is used in combination with dietary habits and increased physical activity. The regulatory milestone followed evidence from the SURMOUNT-OSA phase 3 trials, which evaluated the therapy over a 52-week period.
In those studies, participants who received Zepbound experienced what regulators termed a statistically significant and clinically meaningful reduction
in episodes of shallow breathing or temporary pauses in breathing while asleep compared to those who received a placebo, the FDA said. The improvement appeared in participants using positive airway pressure machines and those who did not.
According to data from scientists from the University of Pittsburgh Medical Center, who analyzed existing data on the use of drugs in this group in patients with OSA including two studies with a total of 469 patients suffering from moderate or severe obstructive sleep apnea and treated with tirzepatide, patients lost an average of about a fifth of their body weight, while improvements in sleep apnea were significant. According to the results, they had over 20 fewer episodes of apnea for every hour of sleep.
How the Medication Affects Airway Function
Obstructive sleep apnea occurs when a person’s upper airway becomes blocked, causing pauses in breathing during sleep. The National Council on Aging explains that OSA occurs when the muscles and tissues within the throat relax during sleep, blocking the airway. While OSA can affect anyone, it is more common in those who are overweight or have obesity, says Steve Carstensen, D.D.S., a specialist in sleep-related breathing disorders and dental sleep medicine based in Seattle. This approval helps people struggling with sleep apnea get coverage for Zepbound,
he explains. If they can lose weight, it could help them breathe better, which often leads to improved OSA management.
Beyond general weight reduction, a new research review published in JAMA Otolaryngology on September 3 found that glucagon-like peptide-1 (GLP-1) receptor agonists may offer significant improvement in obstructive sleep apnea (OSA) related to obesity. The effects were especially true for tirzepatide (Zepbound, Mounjaro), which also acts on glucose-dependent insulinotropic polypeptide (GIP) receptors. Zepbound works by activating receptors of hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake. By reducing body weight, studies show that Zepbound also improves OSA, appearing to improve OSA associated with obesity by promoting fat loss in the neck, throat, and tongue.
Relationship With Standard CPAP Therapy
Historically, the condition known as obstructive sleep apnea (OSA) was typically treated with lifestyle changes and the use of a continuous positive air pressure (CPAP) machine. While those approaches still hold plenty of merit, there’s a new tool in doctors’ kits: An approved medication that may finally make a solid night’s sleep more than a dream for people struggling with OSA. Last December, the U.S. Food and Drug Administration (FDA) approved Zepbound (tirzepatide) for the treatment of moderate-to-severe OSA in adults with obesity, with the understanding that it would be used in combination with dietary habits and increased physical activity.
CPAP therapy should be continued until a physician has confirmed remission with a sleep study. GLP-1 medications prescribed for weight loss, such as Zepbound and Wegovy, show promise for easing symptoms associated with sleep apnea. One study enrolled participants using positive airway pressure.
Long-Term Management and Discontinuation Risks
The FDA approved Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with dietary habits and increased physical activity. Up to half of patients who used tirzepatide, a drug widely known by the trade name Mounjaro, achieved complete remission of sleep apnea. Sleep apnea causes breathing to stop and start repeatedly during sleep. If left untreated, it can be linked to serious health problems, including high blood pressure, stroke, type 2 diabetes, heart disease, and depression. The most common form is obstructive sleep apnea, known as OSA.
