FDA approves first-ever medication for obstructive sleep apnea

The first-ever drug to treat obstructive sleep apnea (OSA) was approved by the Food and Drug Administration (FDA).

Zepbound (tirzepatide), a recently licensed medication, is intended for obese adults with moderate to severe OSA. It should be used in conjunction with a diet lower in calories and more exercise.

According to Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care at the FDA’s Center for Drug Evaluation and Research, the clearance today represents the first medication therapy option for certain people with obstructive sleep apnea.

The most prevalent type of sleep apnea, OSA, is caused by blockages in the upper airway, which causes breathing pauses while you’re asleep. Although it can affect anyone, people who are overweight or obese are more likely to have it; in males who are obese, the prevalence can approach 40%, and in very obese people with high BMIs, it can reach 90%.

OSA is common, affecting at least 10% of adults worldwide and 2% to 4% of children, according to MedlinePlus. The disorder is roughly twice as common in boys as in girls.

Excessive daytime sleepiness, loud snoring (though not always), episodes of stopped breathing during sleep, waking in the middle of the night with gasping or choking, morning headaches, dry mouth or sore throat, difficulty focusing during the day, and elevated blood pressure are some of the symptoms of OSA.

A continuous positive airway pressure (CPAP) machine is usually the primary treatment for sleep apnea. It prevents breathing pauses by supplying humidified air through the nose and sustaining air pressure to keep the throat open as you sleep.

Zepbound, a novel medication, helps lower hunger and food intake by activating receptors for hormones released from the intestine, such as glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1).

Based on two studies involving 469 adults without Type 2 Diabetes, the FDA authorized Zepbound for adults with obesity who have moderate to severe OSA.

Participants in one research used positive airway pressure (PAP), while those in the second trial were unable or unwilling to utilize PAP. For 52 weeks, participants received a weekly dose of either 10 or 15 mg of Zepbound or a placebo.

The apnea hypopnea index (AHI), which measures how frequently a person stops or has short breaths while they sleep, was the primary indicator of efficacy.

When compared to placebo, participants who used Zepbound experienced a substantial decrease in apnea and hypopnea episodes as determined by AHI after 52 weeks of treatment. In comparison to a placebo, Zepbound helped more people achieve remission or moderate OSA, and the results demonstrated a significant improvement in OSA symptoms. Significant weight loss was another benefit of Zepbound, which probably helped explain the improvement in OSA.

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