Learn About CONTRAVE

Diet and exercise alone not working for you? Learn how CONTRAVE can help

When you have found that—regardless of your commitment—your attempts with diet and exercise programs are just not working on their own, it might be time to talk with your doctor about adding prescription weight-loss medication CONTRAVE. Adding CONTRAVE to a diet and exercise plan has helped thousands of people lose weight and keep it off. And unlike other weight-loss medications, CONTRAVE is not a controlled substance, scheduled drug, or stimulant.

Is CONTRAVE Right for Me?

CONTRAVE Is Approved for Use in Adults Based on Body Mass Index (BMI) and Weight-Related Medical Conditions

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at least 1 weight-related medical condition (such as high blood pressure, high cholesterol, type 2 diabetes)

or

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at least 1 weight-related medical condition (such as high blood pressure, high cholesterol, type 2 diabetes)
or

Body mass index (BMI) is a measure of body fat based on height and weight. BMI is a simple screening method to help doctors determine if a patient is underweight, healthy weight, overweight, or obese. This measurement can be a first indicator if a patient is at risk for any weight-related health problems.

Let’s see if your BMI is within the range to take CONTRAVE:

Calculate Your BMI and CONTRAVE Eligibility

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Check all related conditions that you may have:

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You must be 18 or older to be eligible for CONTRAVE.

Your results show you may be a candidate for CONTRAVE. Talk to a doctor to see if CONTRAVE is right for you.

You do not meet the indicated criteria for using CONTRAVE. Even so, it’s always a good idea to talk with your doctor about your desire to lose weight.

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How CONTRAVE Works

When thinking about losing weight, it helps to understand how people relate to food. In the past few decades, scientists have begun to identify how the body’s mechanisms can dictate how often we eat, and even what we love to eat, without us even realizing.

Food & Your Body

Hunger and cravings are real weight-loss challenges that your brain is controlling

Hunger is when your brain tells you it needs nutrition, and any food will satisfy this need

Craving is when your brain wants specific foods, even when you may not feel hungry

Did you know?

You are not alone. 9 out of 10 people who don’t achieve their weight-loss goals are also having difficulty with hunger and cravings.

Your Weight-Loss Struggles Could Be Showing Up in Different Ways

Stress Eating

Continuous Hunger

Comfort-Food Snacking

Do any of these situations sound familiar? Talk to a doctor to see if CONTRAVE may help you lose weight and keep it off.

Did you know that cravings and hunger are one of the main reasons your weight-loss efforts can fail?

This is why weight loss can be complicated because there are signals between your brain and your body that could be working against you.

You are less likely to lose weight with diet and exercise alone if you struggle with cravings.

Managing your cravings and hunger can help you achieve your healthy weight goal.

It is worth figuring this out because even a modest weight loss of 5%-10% of your total body weight is likely to produce health benefits.

Set Point Theory Can Help Explain Continuous Hunger

Your set point could be contributing to weight-loss struggles.

Set Point Theory Can Help Explain Continuous Hunger

Another important point to know is that your body is thought to be programmed to defend against weight loss and maintain a certain range of body weight referred to as set point. This range of body weight may be determined by your heaviest past weight.

This could explain why the more you diet, the hungrier you may get and the more cravings you may have. When you start to lose weight, your brain causes hunger and cravings that seem uncontrollable. This is your body’s attempt to bring your body weight back to its pre-determined level or set point.

The Science Behind CONTRAVE

The Struggle to Lose Weight and Keep It Off Is Real

There is a real weight-loss struggle that happens to many of us—and it’s not due to lack of commitment or effort. Through science, we can better understand this challenge because it turns out your brain may be working against you by sending hunger signals or triggering cravings, even when you’re not hungry.

See how 2 areas in the brain can cause hunger and cravings*

*Other areas of the brain may be involved.

Our brains play a role in the struggle to lose weight:

The hunger center (hypothalamus) can reduce hunger, telling you to eat again or eat more

The mesolimbic circuit or reward system can create cravings that seem uncontrollable even when you’re not hungry

The Science Behind CONTRAVE

See how CONTRAVE is thought to act on those same 2 areas of the brain

The hypothalamus (hunger center) to reduce hunger

The mesolimbic reward system to help control cravings

The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood.

 

CONTRAVE combines 2 medications that together reduce hunger and control cravings to help you lose weight and keep it off: bupropion HCl and naltrexone HCl.

 

Both medicines have well-established safety profiles and have been prescribed by doctors for other conditions for more than 30 years. However, the individual medicines in CONTRAVE are not approved for weight loss when used on their own, and CONTRAVE is not approved to treat depression or other mental illnesses, alcohol or opioid dependency, or to help people quit smoking.

CONTRAVE was studied for efficacy and safety in several clinical trials

The efficacy and safety of CONTRAVE were assessed in the 56-week CONTRAVE Obesity Research (COR) clinical studies.

Who Participated?

  • COR-I and COR-BMOD enrolled adults struggling with obesity (BMI of 30 kg/m2 or greater) or who were overweight (BMI of 27 kg/m2 or greater) with at least one weight-related medical condition, such as high blood pressure or high cholesterol.
  • In COR-I, the average baseline weight before starting the study was about 220 pounds for patients in the CONTRAVE group and 219 pounds in the placebo group, and the average waist circumference was 43 inches for both groups.
  • In COR-BMOD, the average baseline weight before starting the study was about 221 pounds for patients in the CONTRAVE group and 224 pounds in the placebo group, and the average waist circumference was 43 inches for both groups.
  • COR-Diabetes enrolled patients with a BMI of 27 kg/m2 or greater with type 2 diabetes who were not achieving a glycemic goal of HbA1c less than 7% either with oral antidiabetic agents or with diet and exercise alone. The average baseline weight before starting the study was about 229 pounds for patients in the CONTRAVE group and 232 pounds in the placebo group, and the average waist circumference was 45 inches for both groups.

What Did They Do?

Some participants received CONTRAVE, and others were randomly selected to receive a placebo.

  • COR-I: 538 patients received CONTRAVE and 536 patients received a placebo.
  • COR-BMOD: 565 patients received CONTRAVE and 196 patients received a placebo.
  • COR-Diabetes: 321 patients received CONTRAVE and 166 patients received a placebo

Both groups participated in lifestyle modification programs that included a reduced-calorie diet and regular physical activity. COR-BMOD also included an intensive behavioral modification program consisting of 28 group counseling sessions over 56 weeks.

In each of the COR studies, the co-primary endpoints used to determine if CONTRAVE was effective at Week 56 were the percent change from baseline body weight and the percentage of patients achieving at least a 5% reduction in body weight.

CONTRAVE Clinical Studies Showed Long-Term Weight Loss

CONTRAVE is a long-term approach that works when added to a diet and exercise to help you achieve sustainable results

Three different clinical studies showed how patients taking CONTRAVE, along with diet and exercise, lost 2-4x more weight than with diet and exercise alone.

Across 3 different clinical studies, patients struggling with obesity who took CONTRAVE, along with diet and exercise, lost 2-4 times more weight over 1 year than with diet and exercise alone.

What Happened?

Along with diet and exercise, patients taking CONTRAVE lost more weight after 56 weeks of treatment than patients taking placebo.

The CONTRAVE group lost an average of 5.4% of their baseline body weight (or 12 pounds) compared with the placebo group, which lost an average of 1.3 % of their body weight (or 3 pounds).

 

In addition, 42% of CONTRAVE patients lost at least 5% of their total body weight (compared to 17% of placebo patients), and 21% of CONTRAVE patients lost at least 10% of their total body weight (compared with 7% of placebo patients).

 

Finally, the average waist reduction for patients taking CONTRAVE was 2.4 inches, compared to 1 inch for those in the placebo group.

The CONTRAVE group lost an average of 8.1% of their baseline body weight (or 18 pounds) compared with the placebo group, which lost an average of 4.9% of their body weight (or 11 pounds).

 

In addition, 57% of CONTRAVE patients lost at least 5% of their total body weight (compared with 43% of placebo patients), and 35% of CONTRAVE patients lost at least 10% of their total body weight (compared to 21% of those in the placebo group).

 

Finally, the average waist reduction for patients taking CONTRAVE was 3.9 inches, compared to 2.7 inches for those in the placebo group.

The CONTRAVE group lost an average of 3.7% of their baseline body weight (or 8.5 pounds) compared with the placebo group, which lost an average of 1.7% on average (or 4 pounds).

 

In addition, 36% of CONTRAVE patients lost at least 5% of their total body weight (compared with 18% of placebo patients), and 15% of CONTRAVE patients lost at least 10% of their total body weight (compared to 5% of those in the placebo group).

 

Finally, the average waist reduction for patients taking CONTRAVE was 2 inches, compared to 1.1 inches for those in the placebo group.

 

When added to diet and exercise, CONTRAVE is a long-term approach to help you achieve sustainable results. Your results may vary depending on your weight, body mass index (BMI), diet, activity level, and other factors.

What to Expect

We want to answer your questions and support you on your weight-loss journey. These FAQs provide you with safety and side effects information that is important to understand at the start of your journey with CONTRAVE. For more detailed information about CONTRAVE, visit our Prescribing Information and Medication Guide, or call one of our customer service representatives at 1-800-905-5576.

If you’re new to CONTRAVE, it’s important to follow your doctor’s direction and increase your dose slowly over the first month to help you adjust to the medication. Most patients begin with 1 morning pill during the first week and gradually work their way up to 2 pills twice a day by week 4. This dosing schedule was followed by the patients in the CONTRAVE clinical trials who achieved weight-loss success when CONTRAVE was added to their diet and exercise routine.

Your body needs time to become familiar with medications and increasing your dose over time allows you to adjust to the full dosage. In CONTRAVE clinical trials, most side effects occurred during the dose adjustment period and were mild to moderate in severity.

Remember to always take CONTRAVE exactly as prescribed by your doctor. Refer to the CONTRAVE Dosing Chart below to help you stay on track, and know that some people, like those with kidney or liver problems, or those taking other medications, may need to follow a different dosing schedule.

 

CONTRAVE Dosing Chart: Getting Started and Staying on Track

Dosing for Most Patients Taking CONTRAVE

An icon of a CONTRAVE® patient drinking an 8oz glass of water

An icon of a CONTRAVE® patient drinking an 8oz glass of water

In general, it is recommended you drink plenty of water when taking CONTRAVE. A good rule of thumb is to take CONTRAVE with 8 oz of water. And then throughout your day, drink additional glasses of water—as this can help with both weight loss and, for some people, with preventing constipation.

Pills are featured for illustrative purposes, not shown to actual size.

  • Take CONTRAVE exactly as your doctor tells you to
  • If you have kidney or liver problems, your final dose may be lower (for example, 1 pill in the morning and 1 pill in the evening or 1 pill in the morning)
  • Your doctor will change your dose if needed
  • Do not change your CONTRAVE dose without talking with your doctor
  • Your doctor should tell you to stop taking CONTRAVE if you have not lost a certain amount of weight after 16 weeks of treatment
  • Swallow CONTRAVE pills whole. Do not cut, chew, or crush CONTRAVE pills. Tell your doctor if you cannot swallow CONTRAVE pills whole
  • Do not take more than 2 pills in the morning and 2 pills in the evening
  • Do not take more than 2 pills at the same time or more than 4 pills in 1 day
  • Do not take CONTRAVE with high-fat meals. It may increase your risk of seizures
  • If you miss a dose of CONTRAVE, wait until your next regular time to take it. Do not take more than 1 dose of CONTRAVE at a time
  • If you take too much CONTRAVE, call your doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room

What is the most important information I should know about CONTRAVE?

CONTRAVE can cause serious side effects, including:

  • Suicidal thoughts or actions. One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.

Stop taking CONTRAVE and call a doctor right away if you, or your family member, have any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood
  • trouble sleeping (insomnia)

While taking CONTRAVE, you or your family members should:

  • pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes
  • keep all follow-up visits with your healthcare provider as scheduled. Call your doctor between visits as needed, especially if you have concerns about symptoms

CONTRAVE has not been studied in and is not approved for use in children under the age of 18.

Who should not take CONTRAVE?

Do not take CONTRAVE if you:

  • have uncontrolled hypertension
  • have or have had seizures
  • use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN, and ZYBAN
  • have or have had an eating disorder called anorexia (eating very little) or bulimia (eating too much and vomiting to avoid gaining weight)
  • are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal
  • drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them all of a sudden
  • are taking medicines called monoamine oxidase inhibitors (MAOIs). Ask your doctor or pharmacist if you are not sure if you take an MAOI, including linezolid. Do not start CONTRAVE until you have stopped taking your MAOI for at least 14 days
  • are allergic to naltrexone or bupropion or any of the ingredients in CONTRAVE. See the Medication Guide for a complete list of ingredients in CONTRAVE

What should I tell my doctor about other medical conditions I may have?

Before taking CONTRAVE, tell your doctor about all of your medical conditions, including if you:

  • have or have had depression or other mental illnesses (such as bipolar disorder)
  • have attempted suicide in the past
  • have or have had seizures
  • have had a head injury
  • have had a tumor or infection of your brain or spine (central nervous system)
  • have had a problem with low blood sugar (hypoglycemia) or low levels of sodium in your blood (hyponatremia)
  • have or have had liver problems
  • have high blood pressure
  • have or have had a heart attack, heart problems, or have had a stroke
  • have kidney problems
  • are diabetic taking insulin or other medicines to control your blood sugar
  • have or have had an eating disorder
  • drink a lot of alcohol
  • abuse prescription medicines or street drugs
  • are over the age of 65
  • are pregnant or plan to become pregnant. Losing weight while pregnant may harm your unborn baby. Stop taking CONTRAVE if you become pregnant. Tell your healthcare provider if you become pregnant or you think you may be pregnant during treatment with CONTRAVE
  • are breastfeeding or plan to breastfeed. CONTRAVE can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you should take CONTRAVE or breastfeed. You should not do both

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONTRAVE may affect the way other medicines work and other medicines may affect the way CONTRAVE works, causing side effects. Ask your doctor for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

What are the most serious side effects of CONTRAVE?

  • Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who:

    • take higher doses of CONTRAVE
    • have certain medical conditions
    • take CONTRAVE with certain other medicines

    Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them.

    If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away. You should not take CONTRAVE again if you have a seizure.

  • Risk of opioid overdose. One of the ingredients in CONTRAVE (naltrexone) can increase your chance of having an opioid overdose if you take opioid medicines while taking CONTRAVE.

    You can accidentally overdose in 2 ways:

    • Naltrexone blocks the effects of opioids, such as heroin, or opioid pain medicines. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death.
    • After you take naltrexone, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with naltrexone can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
      • after you have gone through detoxification
      • when your next dose of CONTRAVE is due
      • if you miss a dose of CONTRAVE
      • after you stop CONTRAVE treatment

    It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

    You or someone close to you should get emergency medical help right away if you:

    • have trouble breathing
    • become very drowsy with slowed breathing
    • have slow, shallow breathing (little chest movement with breathing)
    • feel faint, very dizzy, confused, or have unusual symptoms
  • Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.
  • Severe allergic reactions. Some people have had a severe allergic reaction to bupropion, one of the ingredients in CONTRAVE. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction:

    • rash
    • itching
    • hives
    • fever
    • swollen lymph glands
    • painful sores in your mouth or around your eyes
    • swelling of your lips or tongue
    • chest pain
    • trouble breathing
  • Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE.
  • Liver damage or hepatitis. One of the ingredients in CONTRAVE, naltrexone can cause liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems:

    • stomach area pain lasting more than a few days
    • dark urine
    • yellowing of the whites of your eyes
    • tiredness

    Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem.

  • Manic episodes. One of the ingredients in CONTRAVE, bupropion can cause some people who were manic or depressed in the past to become manic or depressed again.
  • Visual problems (angle-closure glaucoma). One of the ingredients in CONTRAVE, bupropion, can cause some people to have visual problems (angle-closure glaucoma). Signs and symptoms of angle-closure glaucoma may include:

    • eye pain
    • changes in vision
    • swelling or redness in or around the eye

Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it if you are at risk.

  • Increased risk of low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat their diabetes. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE.

What are the most common side effects when taking CONTRAVE?

The most common side effects of CONTRAVE include:

    • nausea
    • constipation
    • headache
    • vomiting
    • dizziness
    • trouble sleeping
    • dry mouth
    • diarrhea

These are not all the possible side effects of CONTRAVE. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What can I do to manage the common side effects of CONTRAVE?

If you do experience some of the common side effects, there are things you can do to manage them. For instance:

  • Nausea: In general, it is recommended you drink plenty of water when taking CONTRAVE. If you experience nausea, you may also want to eat a small amount of dry toast with CONTRAVE. For most people, this symptom went away within the first 4 weeks of taking CONTRAVE. If symptoms do not improve, please consult with your doctor who may also recommend an over-the-counter anti-nausea medication for you.
  • Constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea have also occurred and usually can be managed with over-the-counter products your doctor can recommend.

Call your doctor if you do experience any side effects while taking CONTRAVE that bother you or don’t go away.

Success Stories

Meet People Who Lost Weight and Kept It Off With CONTRAVE