*An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone.
Cobenfy (xanomeline and trospium chloride) is a prescription medication used to treat schizophrenia in adults. It works by targeting muscarinic receptors in the brain to help manage symptoms. This medication can have potential side effects, such as nausea, constipation, and increased heart rate. The recommended dose for Cobenfy is one capsule by mouth twice daily at least 1 hour before or 2 hours after a meal.1
Key takeaways
Cobenfy is a new FDA-approved antipsychotic medication to treat schizophrenia in adults. It is not approved for use for children or teens under the age of 18.
Cobenfy has a lower risk of side effects than standard schizophrenia treatments, but it is not without risks.
Cobenfy is available as a capsule that is taken twice daily without food, specifically 1 hour before or 2 hours after a meal. Your dosage of Cobenfy will likely be increased slowly during the first week or two of treatment.
If you are looking to get to Cobenfy, a good place to start is with an evaluation from a medical provider. Lifestance Health is a reliable online psychiatry platform offering online assessments and medication management.
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What Is Cobenfy (Xanomeline & Trospium Chloride)?
Cobenfy, with the active ingredients xanomeline & tropism chloride, is an FDA-approved medication for the treatment of schizophrenia in adults. FDA approval means that the U.S. Food and Drug Administration has reviewed the drug through clinical trials and research studies and has determined the drug to be both safe and effective.
Together, Xanomeline and trospium chloride affect the activity of certain brain receptors to manage schizophrenia symptoms. Cobenfy is only available as a brand name with no generic options available currently.1
How Does Cobenfy Work?
Cobenfy works by helping balance certain chemicals and signals in the brain. Xanomeline, one of the active ingredients in Cobenfy, helps activate brain receptors that improve communication between brain cells. Trospium chloride, the other active ingredient in Cobenfy, blocks brain receptors that can cause overstimulation. By balancing these effects, Cobenfy can help reduce symptoms like hallucinations, confusion, and disorganized thinking in people with schizophrenia.1,2,3
What Is Cobenfy Used to Treat?
Cobenfy is FDA-approved for the treatment of schizophrenia in adults. Schizophrenia is a psychiatric condition that impacts how a person thinks, feels, and behaves, often making it seem like they have lost touch with reality. This can be distressing both for the individual and their loved ones.
Common symptoms of schizophrenia include hallucinations, delusions and disorganized thinking, which can make everyday activities very difficult. Cobenfy helps manage these symptoms by targeting specific receptors in the brain, which can improve clarity of thought and reduce disruptive behaviors.2
As a newly approved medication, Cobenfy is specifically intended as a treatment for schizophrenia. Currently, there are no off-label uses for this drug, meaning it is only prescribed for treating schizophrenia as approved by the FDA.1
How Effective Is Cobenfy?
Cobenfy has been shown to be effective in treating schizophrenia in adults. In two clinical research trials involving 470 patients, Cobenfy significantly reduced schizophrenia symptoms. In these studies, patients on Cobenfy saw a notable improvement in symptoms by week 5. These trials supported the effectiveness in managing schizophrenia, although more research is ongoing to fully understand its long-term safety and effects. 1
Cobenfy lasts for about 12 hours after each dose. The medication is typically taken twice daily, with the doses 12 hours apart, to maintain steady levels and manage symptoms throughout the day. The duration of the effect is consistent across different doses given.1
How Long Does it Take for Cobenfy to Work?
Cobenfy begins to take effect within hours after taking a dose. Some may notice a change in schizophrenia symptoms within the first week of treatment, but it can take up to several weeks to see full benefits. Cobenfy is designed to be taken twice daily. Because the drug reaches a steady state in the body over time, symptoms get better gradually.
In clinical trials, significant improvements in symptoms were observed by Week 5. However, individual responses may vary, and it’s important to continue taking the medication as prescribed for best results.1
How Long Do I Need to Keep Taking Cobenfy?
The duration of treatment with Cobenfy is typically determined by your healthcare provider based on individual treatment response. It is important to follow the provider’s recommendations and attend regular check-ups to monitor medication effectiveness and side effects. Long-term treatment may be necessary for managing schizophrenia symptoms.1
Common Side Effects of Cobenfy
Common Cobenfy side effects may include nausea, dizziness, stomach discomfort, or increased heart rate. These effects result from the medication’s action in the body. While some individuals may need medical care for persistent or severe symptoms, most side effects are mild and tend to lessen after the first few days or weeks of treatment.1
Common side effects of Cobenfy include:*1
- Nausea
- Indegestion
- Stomach pain (abdominal pain)
- Constipation
- Diarrhea
- Heartburn
- Vomiting
- Fast heart rate
- Dizziness
- High blood pressure
- GERD (gastroesophageal reflux disease)
*All medications, including Cobenfy, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor and pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.
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Serious Side Effects of Cobenfy
Serious side effects of Cobenfy may occur, requiring immediate medical attention. These serious side effects often affect the heart, gastrointestinal system, or bladder, and their severity may vary depending on individual health conditions. Patients experiencing such symptoms should seek medical care promptly due to the possible life-threatening nature of these effects.1
Serious side effects of Cobenfy include:*1
- Urinary retention
- Increased heart rate
- Liver damage
- Bile duct blockage
- Slowed movement within the digestive tract
- Angioedema (swelling of face, lips or throat)
- Increased heart rate
- Severe central nervous depression like confusion, dizziness, hallucinations, drowsiness
*All medications, including Cobenfy, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor and pharmacist about any questions you have and to understand the potential side effects and benefits of any medication.
What Are The Long-term Effects of Taking Cobenfy?
Since Cobenfy is a newly approved drug, long-term effects are still being studied, and comprehensive data are limited. However, ongoing research, such as the EMERGENT-4 study, focuses on assessing its long-term safety, tolerability, and efficacy in patients with schizophrenia over a 53-week period. The study monitors treatment-emergent adverse events and serious side effects, helping gather essential data on the drug’s long-term impact.
There are no definitive conclusions about long-term effects, but current research is closely monitoring potential risks. This includes cardiovascular, gastrointestinal, and neurological side effects, which have been observed during shorter-term use. More data from ongoing and future studies will provide a clearer picture of Cobonefy’s long-term safety profile.
Pros & Cons of Taking Cobenfy
Fewer side effects than other antipsychotic medications
Additional new option if existing antipsychotics haven’t worked well
Effectively improves symptoms
Patient support program offering discounts
Pros
Still some side effects to be aware of
Not available as a generic
Not approved for children or teens under 18
Can be costly, even with insurance
Cons
What Are the Risks & Warnings for Cobenfy?
Confusion or Hallucinations
Some patients, particularly older adults or those with certain medical conditions, may experience confusion, dizziness, or even hallucinations while taking Cobenfy. Caution is advised when performing tasks that require alertness, such as driving.
Problems Emptying Bladder Completely
Cobenfy may cause difficulty emptying the bladder completely (urinary retention), especially in older adults or those with bladder issues such as an enlarged prostate. Patients should watch for symptoms like trouble starting to urinate or a weak stream.
Liver Damage
Cobenfy can increase the risk of liver injury, particularly in those with liver problems. Regular monitoring of liver enzymes is required, and symptoms such as yellowing skin or dark urine should be reported immediately.
Bile Duct Blockage
Some patients may experience problems with bile flow, leading to gallstones and pancreatitis. Symptoms like upper abdominal pain, nausea, or vomiting should prompt medical attention.
Slowed Digestion
Cobenfy may reduce the movement of food through the stomach, especially in patients with pre-existing gastrointestinal issues such as colitis or myasthenia gravis. Watch for signs of stomach pain or constipation.
Angioedema (Severe Swelling)
Swelling of the face, lips, tongue, or throat has been reported and may require emergency care.
Increased Heart Rate
Cobenfy may raise heart rates, especially in patients with pre-existing heart conditions. Monitoring heart rate during treatment is recommended.
Narrow-angle Glaucoma Risk
Cobenfy can trigger or worsen glaucoma in those with anatomically narrow angles. Patients with this eye condition should use the medical only under close supervision.
Central Nervous Side Effects
Cobenfy can cause side effects that affect the central nervous system (CNS), also called anticholinergic CNS side effects. These include dizziness, confusion, hallucinations, and drowsiness. Those with kidney problems may experience stronger anticholinergic side effects like dry mouth, constipation, or trouble urinating. The medication is not recommended for individuals with moderate to severe kidney impairment.
There may be additional warnings or precautions with this medication. Talk with your provider and pharmacist about all the risks before you start taking this medication.
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Who Should Not Take Cobenfy?
Cobenfy should not be taken by individuals with certain medical conditions or sensitivities. People with urinary retention, severe liver impairment, or untreated narrow-angle glaucoma should avoid the medication due to the risk of serious complications.
Additionally, individuals who are allergic to xanomeline, trospium chloride, or any of the ingredients in Cobenfy should avoid it. Caution is also advised for those with mild liver issues or those taking medications that interact with Cobenfy.1
People who may need to avoid taking Cobenfy include:
- Pregnant and breastfeeding parents
- People with urinary retention or bladder issues
- People with kidney problems
- People with liver problems
- People with narrow-angle glaucoma
- People allergic to xanomeline, trospium chloride, or any ingredients in Cobenfy
- People taking medications that affect liver function or cause drug interactions
Drug Interactions With Cobenfy
Cobenfy can interact with various medications, substances, and herbs, leading to an increased risk of side effects or reduced effectiveness of treatment. These interactions can result in harmful outcomes, such as increased side effects or altered drug absorption. It is important to inform your healthcare provider about all medications and supplements you are taking. In some cases, immediate medical care may be needed to manage severe interactions.1
5 substances you should avoid while taking Cobenfy include:
- Strong CYP2D6 inhibitors: These medications include certain antidepressants or antipsychotics that can increase levels of xanomeline in the body, leading to more severe side effects like dizziness, confusion, or gastrointestinal issues4
- Drugs eliminated by active tubular secretion: Some medications, like certain diabetes drugs and antibiotics, are filtered out of the body by the kidneys. When taken with Cobenfy, they might cause higher drug levels in the system, leading to worsened side effects like dry mouth or trouble urinating.5
- CYP3A4-sensitive drugs: Oral drugs like certain statins, steroids, etc, can interact with Cobenfy, potentially increasing their levels in the body and leading to a higher risk of muscle pain or liver issues.6
- Substrate of P-glycoprotein: Absorption of drugs like digoxin and others may be increased by Cobenfy, leading to dangerous side effects like irregular heartbeats or dizziness.
- Other antimuscarinic drugs: Taking Cobenfy with other drugs that reduce saliva or slow digestion (like certain antihistamines) can increase the risk of severe dry mouth, constipation, or other anticholinergic side effects.
This is not a comprehensive list of the possible interactions with Cobenfy. You should talk with your provider and your pharmacist about all prescription and over-the-counter medications, herbs, and supplements you take before starting Cobenfy.
Cobenfy Dosages for FDA-Approved Treatment
Cobenfy dosages may vary depending on the individual, with factors like age, liver function, and other health conditions. The typical FDA-approved dosage for adults is 100 mg/20 mg taken twice daily, with the option to increase to 125 mg/30 mg based on how well it is tolerated. Dosages are usually started lower and adjusted gradually to ensure the best balance between effectiveness and managing side effects.1
Cobenfy is approved for treating schizophrenia in adults between 18 and 65 years old. Special considerations may be needed for older adults, and a lower starting dose may be recommended to minimize the risk of adverse effects. For patients with certain health conditions, such as mild liver impairment, dosage adjustments may be necessary to ensure safety. Cobenfy is not approved for any off-label uses as of now.1
Cobenfy Forms & Strengths
Cobenfy is available in oral capsule form, with varying strengths to suit individual treatment. The strengths come in 50 mg/20 mg, 100 mg/20 mg, and 125 mg/30 mg. These capsules contain a combination of xanomeline and trospium chloride. Cobenfy does not come in extended-release or delayed-release forms.
When choosing the right strength of Cobenfy, prescribers consider several factors, including the patient’s age, liver function, and other underlying health conditions. Dosages may be adjusted based on how well the patient tolerates the medication or any side effects that arise. It is important to follow the prescribed dosage and take Cobenfy at consistent times each day at least 1 hour before or 2 hours after meals for the best results.1
Cobenfy is available in the following forms and strengths:1
- 50 milligrams (mg)/20 mg oral capsule
- 100 milligrams (mg)/20 mg oral capsule
- 125 milligrams (mg)/30 mg oral capsule
Cobenfy Dosages for Adults With Schizophrenia
Cobenfy is an FDA-approved medication for treating schizophrenia in adults. It is typically taken twice daily, with dosage adjustments made based on individual tolerance and treatment response. For best results, Cobenfy should be taken at least 1 hour before a meal or 2 hours after, as food can affect how the medication is absorbed. The effects of medication start within hours, but it may take several days or weeks for someone to start to notice the effects.1
Here is Cobenfy dosage information for schizophrenia in adults:1
- Typical starting dosage: The starting dose is 50 mg/20 mg taken twice daily for the first two days. This helps assess tolerance and minimize side effects early on.
- Dosage increases: After two days, the dose is typically increased to 100 mg/20 mg taken twice daily for five days, with adjustments based on tolerance.
- Maximum dosage: The maximum recommended dose is 125 mg/30 mg twice daily, depending on how well the patient responds and tolerates the medication.
How Should I Take Cobenfy?
Cobenfy should be taken exactly as prescribed by the healthcare provider, usually twice a day. It is important to take it at consistent times each day, at least 1 hour before a meal or 2 hours after eating. You should also try to take your Cobenfy doses at the same time each day and exactly 12 hours apart. Cobenfy comes in oral capsule form and should be swallowed whole. It should not be crushed, chewed or opened. It is important to always follow the dosing schedule and instructions provided by the prescriber to ensure the best results and avoid any potential side effects.1
What Happens If I Miss a Dose of Cobenfy?
If you miss a dose of Cobenfy, take it as soon as you remember unless it’s almost time for your next dose. In that case, skip the missed dose and take your next dose at the regular time. Do not take two doses at once to make up for the missed one, as this could increase the risk of side effects. If you’re unsure, consult your healthcare provider for guidance.1
Can You Overdose on Cobenfy?
Yes, you can overdose on Cobenfy. Doing so may lead to symptoms of an overdose like severe dizziness, confusion, hallucinations, extreme dry mouth, constipation, fast heart rate and trouble urinating. In some cases, an overdose could cause more serious symptoms, such as seizures, severe gastrointestinal distress, or dangerous changes in heart rate. It is important to take Cobenfy exactly as prescribed to avoid the risk of overdose.1
What Should You Do If You Take Too Much Cobenfy?
If you take too much Cobenfy, seek medical help immediately. Call 911 or go to the nearest emergency room. You can also contact Poison Control at 1-800-222-1222 for further advice. Do not wait for symptoms to appear, as prompt treatment can help prevent serious complications.1
How to Get a Prescription for Cobenfy
If you are looking to start Cobenfy, or are considering an alternative, start by speaking with a prescriber. To get a prescription for Cobenfy or an alternative in person, start with an evaluation for your symptoms. Your primary care provider, who may be a physician, nurse practitioner, or physician assistant, can help you get the process started. They may make a referral to a psychiatrist or specialist to determine if a prescription Cobenfy alternatives should be included in your treatment plan.
Can I Get Cobenfy Prescribed Online?
It’s possible. Medications like Cobenfy require close monitoring by a healthcare provider to assess their effectiveness, adjust dosages, and manage potential side effects. To get an online prescription for Cobenfy or an alternative, you will start by getting evaluated by an online psychiatry platform. We have thoroughly reviewed platforms like Lifestance Health that prescribe antipsychotic medications.
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Questions to Ask Your Provider
Before starting Cobenfy, begin with an evaluation from your primary healthcare provider. They may refer you to a specialist, such as a psychiatrist, to determine if Cobenfy is appropriate for you. If you need to switch prescribers, online psychiatry services can be a convenient option for continued care and medication adjustments.
Questions to ask your care team about Cobenfy include:
- How safe is Cobenfy?
- How long will it take for me to adjust to taking Cobenfy?
- Am I at risk for more serious symptoms with Cobenfy if I am already taking other medications?
- What is the best dosage of Cobenfy to ensure fewer side effects?
- Should I avoid certain foods or drinks while taking Cobenfy?
- How will Cobenfy interact with my other treatments?
- Is Cobenfy safe for me given my medical history?
- Are there any long-term risks with taking Cobenfy?
- What should I do if I miss a dose of Cobenfy?
- How often will I need follow-up visits while on Cobenfy?
- Can I safely stop taking Cobenfy if needed?
- How will Cobenfy affect my daily activities, like driving or working?
- What should I do if I experience side effects while taking Cobenfy?
Prescriber’s Tips
“Your prescriber will share important information about your Cobenfy prescription. They will explain how to take and store your medication, what to avoid when taking it, and what to do about side effects. Follow these tips for safe and effective use of Cobenfy.
- Cobenfy works best taken on an empty stomach. Taking the medication with food can lessen the medication’s effect. Do your best to take Cobenfy at least 1 hour before or 2 hours after a meal.
- Cobenfy is a new and unique medication to treat schizophrenia. It is important to keep routine appointments with your prescriber to ensure safe treatment.
- Address side effects right away. Use management strategies recommended by your provider, or reach out to your care team. Do not assume that side effects will work themselves out.
- Keep track of how often you use the bathroom while on Cobenfy. Rare but serious side effects include urinary retention and slowing of the digestive tract. It is important to identify changes in bathroom use promptly and seek medical care. “
Frequently Asked Questions
Is Cobenfy Safe for Older Adults?
Cobenfy may be used by older adults, but it has not been specifically studied in patients over 65. Due to the increased risk of urinary retention, especially in older men with bladder issues like benign prostatic hyperplasia (BPH), healthcare providers usually recommend starting with lower doses and gradually increasing them to minimize risks.1
Can Cobenfy Be Used During Pregnancy?
There is limited data on Cobenfy use during pregnancy, so its risks to unborn babies are not well understood. Animal studies suggest possible risks to fetal development at high doses, so Cobenfy should only be used if the potential benefits outweigh the risks.
Can Cobenfy Be Used While Breastfeeding?
For breastfeeding, there is no data on whether Cobenfy passes into human milk, but it has been found in animal milk, so caution is advised. Consult with your healthcare provider before using Cobenfy during pregnancy or while breastfeeding.1
Is Cobenfy an Antipsychotic?
Yes, Cobenfy is an antipsychotic medication used to treat schizophrenia.1
Is Cobenfy Safer Than Other Medications for Schizophrenia?
Cobenfy offers a different mechanism of action compared to traditional antipsychotics, which may result in better tolerability and fewer side effects. However, it is not necessarily safer for everyone. Its safety profile varies depending on individual health conditions and needs.7
Is Cobenfy Better Than Clozapine?
It depends. Cobenfy has a lower risk of side effects than standard schizophrenia medications such as clozapine. Cobenfy has also shown effectiveness in clinical trials, but it is unclear how its effectiveness compares to other medications. Depending on the specific symptoms and needs of individuals, one medicine may be better for some people than another one, and vice versa. Talk with your healthcare provider about the best medicine for your condition.
Can Cobenfy Be Taken With Other Schizophrenia Medications?
It’s not clear yet if this is possible. Taking Cobenfy with other schizophrenia medications is still being studied and more research is needed to know if taking Cobenfy with other schizophrenia medications is safe and efficacious.
Is it Safe to Drive While Taking Cobenfy?
Cobenfy may cause dizziness, confusion or drowsiness, so it is not recommended to drive or operate heavy machinery while taking the medication or until you know how the medication affects you.1
Choosing Therapy strives to provide our readers with mental health content that is accurate and actionable. We have high standards for what can be cited within our articles. Acceptable sources include government agencies, universities and colleges, scholarly journals, industry and professional associations, and other high-integrity sources of mental health journalism. Learn more by reviewing our full editorial policy.
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U.S. National Library of Medicine. (2024). Cobenfy (xanomeline). DailyMed. Retrieved October 19, 2024, from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8f0e73bf-6025-44f6-ab64-0983322de0df
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National Institute of Mental Health. (n.d.). Schizophrenia. Retrieved October 19, 2024, from https://www.nimh.nih.gov/health/topics/schizophrenia
-
ClinicalTrials.gov. (2024). A Phase 2, open-label study to evaluate the safety, tolerability, and efficacy of xanomeline and trospium chloride capsules in patients with schizophrenia (NCT04659174). Retrieved from https://www.clinicaltrials.gov/study/NCT04659174
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Nahid, N. A., & Johnson, J. A. (2022). CYP2D6 pharmacogenetics and phenoconversion in personalized medicine. Expert opinion on drug metabolism & toxicology, 18(11), 769–785. https://doi.org/10.1080/17425255.2022.2160317
-
Wang, K., & Kestenbaum, B. (2018). Proximal Tubular Secretory Clearance: A Neglected Partner of Kidney Function. Clinical journal of the American Society of Nephrology : CJASN, 13(8), 1291–1296. https://doi.org/10.2215/CJN.12001017
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National Center for Biotechnology Information. (2019). Table 1: Adverse effects associated with commonly prescribed antipsychotics. In Schizophrenia (pp. 459-462). Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK553990/table/ch31.Tab1/
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Krystal, J. H. (2024). The FDA approval of Cobenfy: A historic moment in schizophrenia. Psychiatric Times. Retrieved from https://www.psychiatrictimes.com/view/the-fda-approval-of-cobenfy-a-historic-moment-in-schizophrenia
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