Foundayo for Sleep Apnoea: UK Guide

Foundayo for sleep apnoea represents a significant development in the management of moderate-to-severe obstructive sleep apnoea (OSA) in adults living with obesity. Foundayo is a brand name for tirzepatide, a dual GIP and GLP-1 receptor agonist that has received regulatory authorisation for OSA in certain jurisdictions. In the UK, tirzepatide is currently marketed as Mounjaro, and patients should verify the MHRA authorisation status of Foundayo directly with the MHRA. This article explains how tirzepatide works for OSA, its side effects, UK prescribing considerations, and the current regulatory position.

What is Mounjaro (tirzepatide) and how is it used for sleep apnoea?

Foundayo is a brand name associated with orforglipron, a different medicine, and is not a tirzepatide product. The medicine relevant to obstructive sleep apnoea (OSA) is tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. In the European Union, the European Medicines Agency (EMA) has granted a marketing authorisation for Mounjaro (tirzepatide) specifically for the treatment of moderate-to-severe obstructive sleep apnoea in adults with obesity. In the UK, tirzepatide is marketed under the brand name Mounjaro, which holds MHRA authorisation for type 2 diabetes management and chronic weight management. Patients and clinicians should verify the current MHRA authorisation status for the OSA indication directly with the MHRA or via the electronic medicines compendium (emc) at medicines.org.uk/emc, as an EMA authorisation does not automatically apply in Great Britain and a separate MHRA decision is required.^[18]

The mechanism by which tirzepatide may help OSA is primarily through significant weight reduction. Excess adipose tissue around the upper airway is a major contributor to airway collapse during sleep, and reducing body weight can meaningfully decrease the apnoea-hypopnoea index (AHI), which is the standard measure of OSA severity. The AHI counts the number of breathing interruptions per hour of sleep; a score of 15 to 30 events per hour is generally classified as moderate OSA, and above 30 as severe.^[4] Clinical trial data from the SURMOUNT-OSA programme (two randomised, placebo-controlled trials published in the New England Journal of Medicine) demonstrated statistically significant reductions in AHI alongside substantial weight loss in participants treated with tirzepatide compared with placebo, in both those using CPAP and those not using CPAP.^[5][7]

It is important to understand that tirzepatide is not a replacement for established OSA treatments such as continuous positive airway pressure (CPAP) therapy. Rather, it may be considered as part of a broader management plan that includes lifestyle modification and, where appropriate, device-based therapy. Any decision to use tirzepatide for OSA should be made in discussion with a qualified clinician who can assess individual suitability, comorbidities, and treatment goals, in line with NICE guidance on OSA management (NICE NG202).

What side effects should you watch for when taking tirzepatide (Mounjaro)?

The most commonly reported side effects of tirzepatide (the active ingredient in Mounjaro) are gastrointestinal in nature, and these are consistent across the class of GLP-1 and dual GIP/GLP-1 receptor agonists. These include nausea, vomiting, diarrhoea, constipation, and abdominal discomfort. These effects are typically most pronounced when starting treatment or after a dose increase, and they often improve as the body adjusts over several weeks.

Acute pancreatitis has been reported in association with tirzepatide use, including post-marketing reports of necrotising pancreatitis and cases with a fatal outcome.^[8][15] Patients should seek prompt medical attention if they develop persistent, severe abdominal pain, particularly if it radiates to the back. Treatment should be discontinued if pancreatitis is confirmed.

Gallbladder-related events, including gallstones (cholelithiasis) and gallbladder inflammation (cholecystitis), have been reported with this class of medicine, and may be associated with rapid weight loss.^[9][10] Patients should seek medical advice if they develop persistent upper abdominal pain, jaundice, or fever.

Persistent vomiting or diarrhoea can lead to dehydration, which in some cases may affect kidney function. Patients should maintain adequate fluid intake and seek medical advice if they are unable to keep fluids down or if symptoms are severe or prolonged.

Patients with pre-existing diabetic retinopathy, particularly pre-proliferative or proliferative retinopathy, should be aware that rapid improvements in blood glucose control can sometimes be associated with worsening of retinopathy.^[11][12] Ophthalmology review and appropriate glycaemic monitoring are advisable for this group.

Other notable effects include injection-site reactions, fatigue, dizziness, and reduced appetite. Heart rate increases have been observed with tirzepatide; patients with pre-existing cardiac conditions should be monitored appropriately by their clinician. Hypoglycaemia is a risk particularly when tirzepatide is used alongside insulin or sulfonylureas.^[15] Patients should be counselled on the signs of low blood sugar and how to manage it.

If you experience symptoms of a serious allergic reaction, such as difficulty breathing, swelling of the face or throat, or a severe skin rash, call 999 immediately. For other concerning symptoms that are not life-threatening, contact your GP or call NHS 111 for advice. Suspected adverse reactions to tirzepatide can be reported via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk.

Can you get tirzepatide prescribed for sleep apnoea in the UK?

Access to tirzepatide for obstructive sleep apnoea in the UK depends on which brand holds a current MHRA marketing authorisation for that specific indication, and on commissioning decisions made by local Integrated Care Boards (ICBs). Mounjaro is the established UK brand of tirzepatide, authorised by the MHRA for type 2 diabetes management and chronic weight management. The EMA has granted Mounjaro (tirzepatide) a marketing authorisation for moderate-to-severe OSA in adults with obesity in the European Union; however, an EMA authorisation does not confer authorisation in Great Britain, which requires a separate MHRA decision.^[18] Patients and clinicians should verify the current MHRA authorisation status for the OSA indication directly with the MHRA or via the emc before assuming UK availability. Prescribing tirzepatide for OSA outside a clearly defined licensed UK indication requires careful clinical justification, specialist assessment, and adherence to local off-label governance frameworks.

In practice, a clinician assessing a patient for OSA-related treatment with tirzepatide would consider factors including BMI, severity of OSA as confirmed by a sleep study (including AHI score), previous treatment history (including CPAP use and adherence), and the presence of relevant comorbidities such as type 2 diabetes or cardiovascular disease. Specialist sleep or obesity medicine services typically oversee pharmacotherapy decisions for OSA, in line with NICE NG202 referral and management pathways.^[3][4]

Patients with OSA who experience excessive daytime sleepiness should be aware of DVLA guidance on fitness to drive. The DVLA advises that patients with excessive sleepiness due to OSA must not drive and should notify the DVLA; patients should discuss this with their clinician and follow current DVLA rules, which are available on the GOV.^[16][17]UK website.

Patients interested in exploring whether tirzepatide-based treatment may be appropriate for their OSA should begin by speaking with their GP, who can refer them to a sleep specialist or obesity medicine service as needed. Bolt Pharmacy is a GPhC-registered UK online pharmacy offering online weight-management consultations, with prescriber review and pharmacist support; tirzepatide may be one option a prescriber considers following such a consultation, where it is clinically appropriate and where a current MHRA authorisation covers the relevant indication. NHS availability for any specific indication will depend on local ICB commissioning decisions and relevant NICE guidance.

Is tirzepatide (Mounjaro) approved in the UK for treating sleep apnoea?

The regulatory position of tirzepatide for OSA in the UK requires careful clarification. The MHRA authorises medicines for use in Great Britain, and tirzepatide is currently MHRA-authorised under the Mounjaro brand for type 2 diabetes and for chronic weight management. The European Medicines Agency (EMA) has granted a marketing authorisation for Mounjaro (tirzepatide) for the treatment of moderate-to-severe obstructive sleep apnoea in adults with obesity in the European Union; however, an EMA authorisation does not automatically apply in Great Britain. A separate MHRA marketing authorisation is required for a medicine to be lawfully supplied in Great Britain for a given indication. Patients and clinicians should verify the current MHRA authorisation status for the OSA indication directly with the MHRA or via the emc at medicines.org.uk/emc.

NICE may subsequently evaluate tirzepatide for OSA and issue guidance on whether it should be recommended for NHS use in England; however, a NICE technology appraisal recommendation does not automatically result in NHS availability, as local ICBs make commissioning decisions based on their own priorities and resources.

It is also worth noting that tirzepatide carries specific guidance regarding use in pregnancy and breastfeeding. The UK SmPC for Mounjaro advises that tirzepatide should not be used during pregnancy or breastfeeding.^[15][19] Women of childbearing potential should use effective contraception. The SmPC advises using an additional non-oral contraceptive method for four weeks after starting treatment and for four weeks after each dose increase, as oral contraceptive absorption may be transiently affected by gastrointestinal side effects.^[19][15] Patients should confirm the current contraceptive interaction guidance with their prescriber or pharmacist, and refer to the Mounjaro SmPC on the emc for the most up-to-date detail. Anyone with questions about their eligibility or the current approval status of tirzepatide for OSA should speak with their GP or a specialist clinician.

Frequently Asked Questions