Tirzepatide Gets FDA Approval for Sleep Apnea in Adults With Obesity

Tirzepatide (Zepbound; Eli Lilly) is now approved for the treatment of moderate-to-severe obstructive sleep apnea (OSA) with obesity, the Food and Drug Administration announced late last week.

The dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist is the first medication approved in the United States for this indication.

As TCTMD reported in August, topline results from the phase III SURMOUNT-OSA trials showed that maximally tolerated weekly doses of the injectable drug were associated with 25 to 29 fewer sleep apnea events or hypopnea per hour compared with placebo. The reductions were noted in patients on positive airway pressure (PAP) therapy as well as those unable or unwilling to use PAP.

At 52 weeks, participants randomized to tirzepatide had lost an average of 45-50 pounds compared with 4-6 pounds in those on placebo.

Manufacturer Eli Lilly says the drug can be considered in patients with obesity who struggle with fatigue and daytime tiredness and who have an apnea-hypopnea index (AHI) of > 15 on a recent sleep test. The drug is recommended to be used in conjunction with a reduced-calorie diet and increased physical activity.