The FDA approved tirzepatide, a sleep apnea medication known as Zepbound for managing adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. According to the Director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center, Sally Seymour, MD said in a statement, “Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea. This is considered to be a major step towards the treatment of obstructive sleep apnea.
Zepbound is an injectable medication approved by the FDA for adults with moderate to severe obesity and OSA. The once-weekly drug, designed to be used with diet and exercise, provides a new lifeline to patients who have failed with traditional treatments like CPAP or who need added support in managing the disease.
Sleep Apnea Medication
Zepbound’s efficacy in improving sleep apnea was demonstrated in two pivotal phase III clinical trials involving 469 adults without type 2 diabetes. These trials assessed the impact of tirzepatide, the active ingredient in Zepbound, on the apnea-hypopnea index (AHI), a measure of sleep-disordered breathing.
In the first trial involving patients who did not use continuous positive airway pressure (CPAP) therapy, tirzepatide resulted in an average reduction of 25.3 events per hour in AHI after 52 weeks of treatment, compared to only 5.3 fewer events with a placebo.
Similarly, in the second trial involving CPAP users, tirzepatide led to a 29.3-event reduction in AHI versus 5.5 with a placebo. In both trials, 45 percent of patients achieved a 50 percent or more significant reduction in AHI, which is reasonably substantial and indicates promising potential for Zepbound as a sleep apnea treatment.