Mysimba Tablets
This page has been reviewed by
Dr. Nicolette Lammers.
Mysimba is an oral medication containing the active ingredients naltrexone and bupropion. It is used to support weight management in adults with obesity or overweight with weight-related comorbidities and is always combined with a reduced-calorie diet and increased physical activity.
Unlike GLP-1-based medications, Mysimba does not work through the GLP-1 receptor, but through central mechanisms that can influence appetite, reward response, and cravings. Treatment is carried out with prolonged-release tablets and is gradually dose-escalated. It is also important to know that Mysimba is currently not on the market in Germany. Which treatment options are currently appropriate should therefore always be discussed individually with a doctor.
If you would like a medical assessment, you can get advice at our locations or nationwide online via video consultation.
Who is Mysimba suitable for?
Mysimba is intended for adults who want to reduce their weight under medical supervision and who have obesity or overweight with weight-related comorbidities. The medication is used in adults with a body mass index of 30 or more, or from a BMI of 27 if at least one comorbidity such as type 2 diabetes, dyslipidemia, or controlled high blood pressure is also present.
Whether Mysimba is medically appropriate in an individual case always depends on the personal starting point. This includes pre-existing conditions, possible contraindications, concurrent medication, tolerability, and the question of which treatment goals are the priority.
What is Mysimba approved for?
Mysimba is approved for weight management in adults when certain medical requirements are met. The medication is used in addition to a reduced-calorie diet and increased physical activity. This classification is important because Mysimba is not a general solution for weight loss, but a medically supervised treatment option for selected patients.
Whether treatment should be continued should be medically reviewed. If at least 5 percent of the initial body weight has not been lost after 16 weeks of treatment, Mysimba should not be continued.
How does Mysimba work?
Mysimba contains the active ingredients naltrexone and bupropion. The exact mechanism of action is not fully understood. According to current understanding, both substances act on areas of the brain that help regulate food intake, energy balance, and reward-related eating behaviour.
As a result, Mysimba may influence appetite and help reduce calorie intake. How strongly weight, hunger, and eating behaviour change during treatment varies from person to person. In everyday life, diet, physical activity, and structured support play a particularly important role.
How is Mysimba used?
Mysimba is taken as a prolonged-release tablet. Treatment begins with a low dose and is gradually increased over four weeks. It usually starts with one tablet in the morning. From the fourth week onward, the maintenance dose is generally reached with two tablets in the morning and two tablets in the evening.
Important: The dosage is always determined by a doctor. It should not be started, changed, or increased independently. Whether treatment is continued should also be reviewed regularly by a doctor.
How do you take Mysimba?
Mysimba is taken orally. The tablets should be swallowed whole with liquid and preferably taken with food. They must not be split, chewed, or crushed.
If a dose is missed, it should not be taken in addition. Instead, the next prescribed dose should be taken at the usual time.
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Who developed Mysimba?
Manufacturer
Mysimba was developed by Orexigen Therapeutics Ireland Limited. The medication contains the active ingredient combination naltrexone and bupropion and is taken as a prolonged-release tablet.
Availability
Mysimba is approved in the European Union. However, what is important for patients in Germany is this: Mysimba is currently not on the market in Germany. Which treatment options are currently appropriate and whether treatment with Mysimba is suitable and realistic in an individual case should therefore always be discussed with a doctor.
Where can I buy Mysimba?
Mysimba is prescription-only and not available over the counter. However, it is important to know that the medication is currently not on the market in Germany. The Body Clinic therefore does not currently offer Mysimba and cannot prescribe it at present.
Which medication options are currently available and medically appropriate in an individual case should always be assessed by a doctor. You can find an overview of our programmes on our page Prices for medical weight loss.
What are the possible side effects?
The most common side effects mainly include gastrointestinal complaints and symptoms affecting the nervous system. These occur especially at the beginning of treatment or during dose escalation.
- Nausea
- Constipation
- Vomiting
- Dizziness
- Dry mouth
In addition, headaches, sleep disturbances, palpitations, or an increase in blood pressure and pulse may occur, among other things. Because Mysimba may also increase the risk of seizures and psychological symptoms should be taken seriously, medical supervision is particularly important. You can find a more detailed overview with warning signs and classification on our page about Mysimba side effects.
Immediate medical advice is important in the event of seizures, noticeable psychological changes, suicidal thoughts, signs of an allergic reaction, persistent vomiting, significantly elevated blood pressure, or symptoms that worsen rapidly.
Pregnancy, breastfeeding, alcohol, and interactions
Mysimba should not be used during pregnancy, if you are trying to conceive, or while breastfeeding. Alcohol should also not be viewed uncritically. During treatment, it is recommended to reduce alcohol consumption or avoid it as much as possible.
Interactions with opioids are particularly important. Mysimba must not be used together with opioid-containing medicines, in opioid dependence, during opioid substitution therapy, or in acute opioid withdrawal. If opioids are needed because of surgery or another procedure, Mysimba should be stopped at least 3 days beforehand.
Mysimba is also not suitable in cases of uncontrolled high blood pressure, a history of seizures, bipolar disorder, bulimia or anorexia, or if other medicines containing bupropion or naltrexone are being taken at the same time. If you would like to read the full information on use, warnings, and contraindications, you can find more details in the Mysimba package leaflet.
Mysimba treatment in Berlin, Munich, Hamburg, Frankfurt, or online.
How does Mysimba differ from other medications?
The most important difference lies not only in the active ingredients, but above all in the mechanism of action and the dosage form. Mysimba is an oral combination of naltrexone and bupropion. Other medications such as Wegovy, Saxenda, or Ozempic rely on different active ingredients and different treatment approaches. Depending on the medical situation, Mounjaro or Rybelsus may also play a role in the overall assessment.
Mysimba vs. Wegovy
Wegovy contains semaglutide and is injected once weekly. Mysimba is taken daily as a prolonged-release tablet and contains naltrexone and bupropion. Both medications are used for weight management, but they differ significantly in mechanism of action and use. You can read more on our page about Wegovy.
Mysimba vs. Saxenda
Saxenda contains liraglutide and is injected once daily. Mysimba, by contrast, is a tablet treatment combining naltrexone and bupropion. While Saxenda belongs to the GLP-1-based medications, Mysimba works through different central mechanisms. You can find more information on our page about Saxenda.
Mysimba vs. Ozempic
Ozempic contains semaglutide and is primarily aimed at the treatment of type 2 diabetes. Mysimba, by contrast, is approved for weight management. The mode of use also differs: Ozempic is injected once weekly, while Mysimba is taken daily as a tablet. You can find more information on our page about Ozempic.
Is Mysimba covered by health insurance?
In the German statutory health insurance system, medications used for weight loss, appetite suppression, or the regulation of body weight are generally excluded from reimbursement. For this reason, Mysimba is generally not expected to be covered by statutory health insurance in Germany. In addition, Mysimba is currently not on the market in Germany. You can find an overview of organisational and financial questions on our page Prices for medical weight loss.
How can I stop taking Mysimba?
Mysimba should not be stopped, paused, or changed in dosage independently. Whether treatment should be discontinued depends, among other things, on tolerability, blood pressure, pulse, possible interactions, and the course of treatment so far. If symptoms or warning signs are the main concern, you can find further information on our page about Mysimba side effects.
It is also important that treatment is reviewed regularly by a doctor. If at least 5 percent of the initial body weight has not been lost after 16 weeks, Mysimba should not be continued. After that, it should also be reviewed annually together with the treating doctor whether the treatment still makes sense. If a weight loss of at least 5 percent is not maintained after one year, treatment should be discontinued. You can find an overview of our medically supervised programmes under medical weight loss.
What does Mysimba cost?
The cost can vary depending on the supply route and the pharmacy. As Mysimba is currently not on the market in Germany, The Body Clinic does not currently list fixed prices for programmes with Mysimba. You can find an overview of our programmes on the page Prices for medical weight loss.
Can you buy Mysimba in Germany?
Mysimba is approved in the European Union, but it is currently not on the market in Germany. Whether and by which route the medication may be available in an individual case should always be clarified by a doctor.
Do you need a prescription for Mysimba?
Yes. Mysimba is prescription-only and should only be used after medical assessment, counselling, and a treatment decision by a doctor.
Does health insurance cover Mysimba?
In Germany’s statutory health insurance system, medicines used for weight loss, appetite suppression, or body-weight regulation are generally excluded. For that reason, Mysimba is generally not expected to be covered by statutory health insurance.
How much weight can you lose with Mysimba?
This cannot be predicted in general terms. How much weight is lost with Mysimba depends, among other things, on the starting point, diet, physical activity, duration of treatment, and tolerability. Medical monitoring is important: if at least 5% of the initial body weight has not been lost after 16 weeks, treatment should not be continued.
What happens if you miss a Mysimba dose?
A missed dose should not be taken in addition. Instead, the next prescribed dose should be taken at the usual time.
What side effects can Mysimba cause?
More common side effects include nausea, constipation, vomiting, dizziness, and dry mouth. In addition, headaches, sleep disturbances, palpitations, or an increase in blood pressure and pulse may occur. You can read more about this on our page about Mysimba side effects.
Can you drink alcohol while taking Mysimba?
Alcohol should not be consumed uncritically while taking Mysimba. During treatment, it is recommended to reduce alcohol consumption or avoid it as much as possible because side effects and risks may increase.
Can Mysimba be taken together with opioids?
No, this is particularly important. Mysimba must not be used together with opioid-containing medicines, in opioid dependence, during opioid substitution treatment, or in acute opioid withdrawal. If opioids are needed because of an operation or another procedure, Mysimba should be stopped at least 3 days beforehand.
Can you simply stop taking Mysimba?
Mysimba should not be stopped, paused, or changed in dose independently. Whether treatment should be ended depends, among other things, on tolerability, blood pressure, pulse, possible interactions, and the course of treatment so far, and should always be decided by a doctor.
Sources
- Greenway, F.L., Fujioka, K., Plodkowski, R.A. et al. 2010. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. Read study.
- European Medicines Agency (EMA). Mysimba: EPAR overview page. Open page.
- European Medicines Agency (EMA). Mysimba: EPAR summary for the public (German, PDF). Open PDF.
- European Medicines Agency (EMA). Mysimba, INN-Naltrexone hydrochloride/Bupropion hydrochloride: EPAR Product Information. Summary of product characteristics and package leaflet (PDF).
- European Medicines Agency (EMA). Mysimba: EPAR Public Assessment Report. Open assessment report (PDF).
- European Commission. Union Register of medicinal products: Mysimba. Open entry.
- Federal Institute for Drugs and Medical Devices (BfArM). Mysimba (naltrexone/bupropion): EMA points to the risks of using the weight loss medicine together with opioids. Open page.
- Federal Institute for Drugs and Medical Devices (BfArM). Mysimba: Potential long-term cardiovascular risk. Open page.