The weight loss drug Zepbound has received expanded approval from the Food and Drug Administration to also treat obstructive sleep apnea in adults with obesity, according to a statement from drugmaker Eli Lilly on Friday. This decision marks the first drug treatment approved for the disorder, which affects approximately 39 million adults in the United States. Zepbound, which contains the same active ingredient as Lilly’s diabetes drug Mounjaro, was already FDA-approved to treat overweight or obese adults. This expanded approval may encourage more insurance companies to cover the medication, addressing the high cost of weight loss drugs.
Julie Flygare, president and CEO of Project Sleep, emphasized the seriousness of obstructive sleep apnea, highlighting that it is often dismissed as just snoring. The condition occurs when the upper airway becomes blocked during sleep, leading to interrupted breathing and poor sleep quality. Obesity, a major risk factor for sleep apnea, can contribute to various health issues if left untreated.
Research presented at the American Academy of Neurology’s annual meeting suggested that individuals with sleep apnea may be at a higher risk of experiencing memory or cognitive problems. The FDA’s approval of Zepbound aligns with the growing evidence that GLP-1 drugs offer health benefits beyond weight loss. While it remains unclear exactly how Zepbound aids individuals with sleep apnea, the two trials conducted by Lilly showed an average weight loss of around 20% among participants who took the drug.
Dr. Susan Spratt, an endocrinologist at Duke Health, noted that weight loss can often lead to improvements in sleep apnea symptoms. However, achieving weight loss without medication can be challenging for many individuals. Current treatments for sleep apnea, such as PAP machines that deliver positive airway pressure, have limitations and not all patients find them effective or tolerable. The recent recall of CPAP machines by a major manufacturer has prompted interest in alternative treatments, including drug options like GLP-1s.
In light of these developments, the FDA’s expanded approval of Zepbound represents a significant advancement in the treatment options available for individuals with obesity and obstructive sleep apnea.
The Zepbound weekly injectable has the potential to revolutionize the treatment of sleep apnea, offering a convenient alternative to cumbersome machines or enhancing the effectiveness of existing therapies. Dr. Morgenthaler points out that weight loss alone can have a significant impact on the severity of obstructive sleep apnea (OSA) for many patients, but the investigational drug tirzepatide may provide additional benefits through alternative mechanisms. However, challenges such as high cost, side effects, and the need for long-term management plans are still under investigation.
The efficacy of Zepbound in addressing sleep apnea was assessed by Lilly researchers in a study comparing its effectiveness to a placebo in reducing the frequency of breathing interruptions during sleep. The first study did not involve the use of positive airway pressure (PAP) machines, while the second study incorporated their use.
After 52 weeks of treatment, individuals not utilizing PAP therapy experienced an average reduction of 25 breathing events per hour with Zepbound, in contrast to a reduction of five events per hour with the placebo. Among those using PAP machines, Zepbound led to an average reduction of 29 events per hour compared to six events per hour in the placebo group. Notably, after one year, 42% of adults treated with Zepbound and 50% of those using Zepbound in combination with PAP therapy reported either remission of symptoms or a decrease in their severity, according to Lilly.
The approval of Zepbound marks a significant advancement in the field of sleep apnea treatment, as noted by Dr. Spratt. However, the question of whether Zepbound surpasses the effectiveness of PAP therapy necessitates further examination through a direct comparative trial.
Dr. Morgenthaler emphasizes the continued need for alternative treatments, highlighting that a substantial portion of sleep apnea patients also experience insomnia. Merely addressing airway obstruction is insufficient to alleviate the complex symptoms of OSA, underscoring the multifaceted nature of the condition.
In conclusion, the introduction of Zepbound as a weekly injectable treatment option for sleep apnea presents both promise and challenges. While the drug demonstrates efficacy in reducing breathing interruptions during sleep, further research is required to determine its comparative effectiveness with traditional therapies. Addressing the diverse needs of patients with OSA involves a comprehensive approach that goes beyond mechanical interventions, underscoring the importance of ongoing innovation in the field of sleep medicine.
