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Zepbound ® (tirzepatide) injection
2.5 mg/ 5 mg/ 7.5 mg/ 10 mg/ 12.5 mg/ 15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What is the dosing of Zepbound® (tirzepatide) in patients with moderate to severe obstructive sleep apnea and obesity?
The recommended starting dosage for OSA is 2.5 mg injected subcutaneously once weekly for 4 weeks, increasing in 2.5 mg increments after at least 4 weeks until the recommended maintenance dose of 10 mg or 15 mg is reached.
See important safety information, including boxed warning, in the attached prescribing information.
Recommended Dosing for Obstructive Sleep Apnea With Obesity
The recommended starting dosage of tirzepatide for all indications (including the treatment of moderate to severe obstructive sleep apnea [OSA] in adults with obesity) is 2.5 mg injected subcutaneously once weekly for 4 weeks.1
The dosage may be increased in 2.5 mg increments after at least 4 weeks on the current dose (5 mg→7.5 mg→10 mg→12.5 mg→15 mg).1
It is recommended to follow the dose escalation schedule to reduce the risk of adverse reactions.1
The recommended maintenance dose for treatment of moderate to severe OSA in adults with obesity is 10 mg or 15 mg injected subcutaneously once weekly.1
The maximum dosage of tirzepatide for all indications is 15 mg injected subcutaneously once weekly.1
Missed Dose
If a dose is missed, patients can administer tirzepatide as soon as possible within 4 days (96 hours) after the missed dose.1
If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.1
In each case, patients can then resume their regular once-weekly dosing schedule.1
Change of Injection Day
If necessary, the day of weekly administration can be changed as long as the time between the 2 doses is at least 3 days (72 hours).1
Dosing in the SURMOUNT-OSA Clinical Studies
The SURMOUNT-OSA master protocol described two 52-week, phase 3, double-blind, randomized studies of tirzepatide maximum tolerated dose (MTD) (10 or 15 mg) once weekly compared with placebo in 469 adults with moderate to severe OSA and obesity.2
Both of these OSA studies followed the same dosage escalation scheme that was used in the clinical development program for weight management (Dose Escalation Schedule for Tirzepatide in Phase 3 Clinical Studies).1,2
The starting dose of tirzepatide was 2.5 mg and was increased by 2.5 mg every 4 weeks until a MTD of 10 or 15 mg was achieved (Dose Escalation Schedule for Tirzepatide in Phase 3 Clinical Studies).1,2
Figure 1 description: Dose Escalation Schedule for Tirzepatide in Phase 3 Clinical Studies. Initial starting dose of 2.5 mg is escalated after 4 weeks by 2.5 mg to achieve 5 mg. The dose is increased by 2.5 mg every 4 weeks to achieve 10 mg by 12 weeks. The dose is then increased by 2.5 mg every 4 weeks to achieve 15 mg by 20 weeks.
Participants continued with a MTD of
Maintenance Dose Rationale in SURMOUNT-OSA
Alternative Dosing or Treatment Schedules
Routine tirzepatide doses and treatment scenarios that differ from those studied in the phase 3 clinical trial program have not been evaluated and, therefore, there is no clinical data available to provide recommendation.
The health care practitioner may use the information provided, the patient’s prior medical history, and other individual factors in developing a treatment plan. The health care practitioner should consider potential risks and benefits of treatment options and monitor appropriately.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Zepbound [package insert]. Indianapolis, IN: Eli Lilly and Company; 2024.
2Malhotra A, Grunstein RR, Fietze I, et al; SURMOUNT-OSA Investigators. Tirzepatide for the treatment of obstructive sleep apnea and obesity. N Engl J Med. 2024;391(13):1193-1205. https://doi.org/10.1056/NEJMoa2404881
3le Roux CW, Zhang S, Aronne LJ, et al. Tirzepatide for the treatment of obesity: rationale and design of the SURMOUNT clinical development program. Obesity (Silver Spring). 2023;31(1):96-110. https://doi.org/10.1002/oby.23612
4Conterno E, Yuffa I, Woodward B. Eli Lilly and Company diabetes 2019 business update. Eli Lilly and Company. Published June 10, 2019. Accessed January 22, 2025. https://investor.lilly.com/static-files/a5dbe9fa-f45f-41ef-bc16-bc12be6dd606
5Malhotra A, Bednarik J, Chakladar S, et al. Tirzepatide for the treatment of obstructive sleep apnea: rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial. Contemp Clin Trials. 2024(141):107516. https://doi.org/10.1016/j.cct.2024.107516
6Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: January 16, 2025