Xanomeline
Pronunciation: (zan-OH-meh-leen).
- Generic name
- Xanomeline
- Brand names
- Cobenfy
- Drug class
- Muscarinic receptor agonist (xanomeline) combined with a muscarinic antagonist (trospium chloride) to offset peripheral side effects
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What Xanomeline is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Xanomeline works
Xanomeline is a centrally acting muscarinic acetylcholine receptor agonist with selectivity for M1 and M4 subtypes. By stimulating these receptors in the brain, xanomeline modulates neurotransmitter release, particularly dopamine and acetylcholine, which are implicated in the pathophysiology of schizophrenia and other neuropsychiatric disorders. (1)
What Xanomeline is used for
Schizophrenia in adults
Xanomeline is only approved and marketed as part of the fixed-dose combination Cobenfy (xanomeline and trospium chloride) for treating schizophrenia in adults. It is not approved as a standalone medicine, and not approved for Alzheimer’s disease or dementia with Lewy bodies — those were historical investigational uses of xanomeline alone that were never approved. (1)
Before taking Xanomeline
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to xanomeline, untreated narrow-angle glaucoma, or severe gastrointestinal obstruction. (Contraindication) (1)
Tell your clinician about
(1)How to take Xanomeline
- General Instructions: Take Xanomeline exactly as prescribed by your doctor. Do not change your dose or stop taking it without consulting your healthcare provider.. Adult Dosing: Cobenfy (xanomeline/trospium) starting dose is 50 mg/20 mg orally twice daily for at least 2 days, then increased to 100 mg/20 mg twice daily for at least 5 days; may be further increased to 125 mg/30 mg twice daily based on tolerability and response. Take at least 1 hour before or 2 hours after a meal.. Pediatric Dosing: Safety and efficacy in children have not been established. Use in pediatric patients is not recommended.. Administration: Take at least 1 hour before or 2 hours after a meal, as directed by the Cobenfy (xanomeline/trospium) label. Swallow capsules whole with water; do not crush or chew unless directed.. When To Seek Review: Do not stop taking Xanomeline suddenly unless instructed by your doctor, as symptoms may return or worsen.. Storage: Store at room temperature (20–25°C/68–77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, contact your prescriber or pharmacist for guidance on the missed dose and resume your regular schedule. do not take an extra dose to catch up.
Overdose
In case of overdose, seek emergency medical help immediately. Symptoms may include severe nausea, vomiting, confusion, irregular heartbeat, or loss of consciousness. Supportive care and monitoring of vital signs are recommended. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Abdominal cramps
Incidence: Reported in the clinician-authored database; frequency not established
Sweating
Incidence: Reported in the clinician-authored database; frequency not established
Salivation
Incidence: Reported in the clinician-authored database; frequency not established
Bradycardia
Incidence: Reported in the clinician-authored database; frequency not established
Urinary frequency
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
May cause drowsiness or dizziness — serious
Symptoms: May cause drowsiness or dizziness; use caution when performing tasks requiring alertness. Can increase risk of dehydration, especially in hot weather or with vigorous exercise. May worsen symptoms in patients with certain heart conditions. Not recommended during pregnancy or breastfeeding unless clearly needed. Monitor for signs of allergic reaction or severe gastrointestinal symptoms.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with hypersensitivity to xanomeline, untreated narrow-angle glaucoma, or severe gastrointestinal obstruction. Use with caution in patients with cardiovascular disease, arrhythmias, seizure disorders, hepatic or renal impairment, and those at risk for urinary retention.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Xanomeline may interact with anticholinergic drugs, cholinesterase inhibitors, certain heart medications, and other CNS-acting agents. Always inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Xanomeline has no monotherapy label; per the COBENFY (xanomeline/trospium) label, available data are insufficient to establish a drug-associated risk of major birth defects or miscarriage. Discuss the risks and benefits of the combination product with the prescriber if pregnancy is being considered. (1)
Breastfeeding
Xanomeline has no monotherapy label; per the COBENFY (xanomeline/trospium) label, there is no information on the presence of the drug in human milk or its effects on a breastfed infant. Discuss breastfeeding with the prescriber. (1)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Safety not established in children (1)
Renal_impairment
Xanomeline has no FDA-approved monotherapy dosing — it is only approved combined with trospium chloride as COBENFY. Renal: not recommended for moderate or severe renal impairment (eGFR <60 mL/min); no adjustment needed for mild impairment (eGFR 60-<90). Hepatic: COBENFY is contraindicated in moderate or severe hepatic impairment and not recommended in mild hepatic impairment, because xanomeline exposure increases with hepatic dysfunction. (1)
Hepatic_impairment
Xanomeline has no FDA-approved monotherapy dosing — it is only approved combined with trospium chloride as COBENFY. Renal: not recommended for moderate or severe renal impairment (eGFR <60 mL/min); no adjustment needed for mild impairment (eGFR 60-<90). Hepatic: COBENFY is contraindicated in moderate or severe hepatic impairment and not recommended in mild hepatic impairment, because xanomeline exposure increases with hepatic dysfunction. (1)
Monitoring
(1)Storage
Xanomeline is not sold as a standalone product; COBENFY (xanomeline/trospium) capsules are stored at 20-25°C (68-77°F) per the FDA label, with excursions permitted to 15-30°C.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Schizophrenia in adults (as the fixed-dose combination Cobenfy: xanomeline/trospium)
Dose summary: Cobenfy (xanomeline/trospium chloride): start 50 mg/20 mg orally twice daily for at least 2 days, increase to 100 mg/20 mg twice daily for at least 5 days, may further increase to 125 mg/30 mg twice daily based on tolerability and response. Take at least 1 hour before or 2 hours after a meal. Xanomeline is not approved or dosed as a standalone monotherapy for any condition, including Alzheimer’s disease.
Renal context: Per the COBENFY label, patients with mild renal impairment (eGFR 60 to <90 mL/min) show higher systemic exposure to both components but had a similar safety profile to normal renal function in clinical studies; COBENFY is not recommended in patients with moderate or severe renal impairment (eGFR <60 mL/min), since trospium chloride exposure is significantly higher in that population. (3)
Frequently asked questions
What is Xanomeline used for?
Xanomeline is primarily used to treat symptoms of schizophrenia and is being studied for use in Alzheimer's disease and other neuropsychiatric disorders.
How does Xanomeline work?
It works by stimulating muscarinic acetylcholine receptors in the brain, which helps regulate mood, thinking, and behavior.
What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it is almost time for your next dose. do not take an extra dose doses.
Can I drink alcohol while taking Xanomeline?
It is best to avoid alcohol, as it may increase the risk of side effects such as drowsiness or confusion.
Is Xanomeline safe during pregnancy or breastfeeding?
Safety in pregnancy and breastfeeding has not been established. Use only if clearly needed and prescribed by your doctor.
What are the most common side effects?
Common side effects include nausea, vomiting, constipation, dry mouth, headache, and increased sweating.
Can children take Xanomeline?
Xanomeline is not recommended for use in children, as safety and efficacy have not been established.
What happens if I take too much Xanomeline?
Taking too much Xanomeline can lead to an exacerbation of cholinergic side effects, such as excessive sweating, salivation, nausea, vomiting, and diarrhea. In severe cases, it may cause bradycardia, hypotension, or seizures. If an overdose is suspected, seek immediate emergency medical attention or contact a poison control center.
Is Xanomeline safe during pregnancy?
The safety of Xanomeline during pregnancy has not been definitively established. It is crucial to consult with your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your healthcare provider can assess the potential risks and benefits and determine the most appropriate course of action for your individual situation.
What is the mechanism of action of Xanomeline?
Xanomeline is a centrally acting muscarinic acetylcholine receptor agonist with selectivity for M1 and M4 subtypes. By stimulating these receptors in the brain, xanomeline modulates neurotransmitter release, particularly dopamine and acetylcholine, which are implicated in the pathophysiology of schizophrenia and other neuropsychiatric disorders. (1)
What is the generic name of Xanomeline?
The generic name is Xanomeline. It is sold under brand names including Cobenfy.
What class of drug is Xanomeline?
Xanomeline is classed as: Muscarinic receptor agonist (xanomeline) combined with a muscarinic antagonist (trospium chloride) to offset peripheral side effects.
References
- Xanomeline — Prescribing InformationMedGuideGlobal · Global · accessed 2026-08-07 · source 1
- COBENFY (xanomeline and trospium chloride) prescribing informationU.S. National Library of Medicine, DailyMed · United States · accessed 2026-08-07 · source 2
- COBENFY (xanomeline and trospium chloride) capsule — Prescribing InformationDailyMed / FDA · United States · accessed 2026-08-08 · source 3
- Cobenfy — FDA approval record (Drugs@FDA NDA216158)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- Xanomeline — RxNorm normalized drug concept (RXCUI 2694828)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient Xanomeline names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.