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About Vyvanse for Adults with Moderate to Severe B.E.D.

In February 2015, Vyvanse (lisdexamfetamine dimesylate) became the first and only medication approved to treat moderate to severe Binge Eating Disorder in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

It is important to talk to your doctor to see if Vyvanse may be right for you, as medicine is not appropriate for all adults with moderate to severe B.E.D.

Vyvanse may help you get control of your Moderate to Severe Binge Eating Disorder

Jaime:
Binge Eating Disorder, or B.E.D., is something I have…not something I do.
When my doctor told me I had moderate B.E.D., it explained why my eating was so out of control.
I’d often eat a lot more than normal in a short period of time, in secret. It was so upsetting. My doctor told me about Vyvanse, the first medicine approved for adults with moderate to severe B.E.D.
Announcer:
Vyvanse shouldn’t be used for weight loss, or to treat obesity.
It has a high risk of abuse or dependence.
Selling or sharing Vyvanse may harm others and is illegal. Store it safely.
Do not take it if you take MAOIs or are allergic to stimulants.
Some patients taking stimulants like Vyvanse experienced: sudden death, stroke, heart attack and increased blood pressure and heart rate.
Call the doctor if you have chest pain, shortness of breath, or fainting.
New or worsening mental illness has occurred while taking stimulants. Call the doctor if you have changes in mood, behavior, or thoughts.
Circulation problems in the fingers and toes can occur.
Call your doctor if they feel numb, cool, painful, are sensitive to temperature, change color from pale, to blue, to red, or develop unexplained wounds.

Jaime :
Ask your doctor about Vyvanse for moderate to severe B.E.D.…so food can just be food again.

Who should not take Vyvanse (lisdexamfetamine dimesylate)

Do not take Vyvanse if you are taking or have taken within the past 14 days an anti-depressant called a monoamine oxidase inhibitor (MAOI) or are sensitive to, allergic to, or had a reaction to other stimulant medications.

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Why Vyvanse?

It's important to know how Vyvanse may be able to help adults who suffer from moderate to severe B.E.D. Remember, Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. Below are the highlights of two clinical trials in which adults with moderate to severe B.E.D. took Vyvanse or a sugar pill (placebo).

Need Help Controlling Your Moderate or Severe B.E.D. Symptoms?
In two 12-week studies of adults who were diagnosed with moderate to severe Binge Eating Disorder (B.E.D.), Vyvanse (lisdexamfetamine dimesylate) was proven to reduce weekly binge days (a day with at least 1 binge episode).
 
At the end of both Study 1 and Study 2, adults with moderate to severe B.E.D. who took Vyvanse experienced, on average, significantly fewer binge days per week compared to those who took a sugar pill. The change in binge days per week for adult patients with moderate to severe B.E.D. from the start of the study to the end was measured using a statistical measure called the LS-Mean. The results from each study at Week 12 are below.
 
At the end of Study 1, on average, Vyvanse decreased binge days per week by 1.35 days more than a sugar pill (from the start of the study) - that is an average decrease of 3.87 days for Vyvanse and 2.51 days for sugar pill.
 
At the end of Study 2, on average, Vyvanse decreased binge days per week by 1.66 days more than a sugar pill (from the start of the study) - that is an average decrease of 3.92 days for Vyvanse and 2.26 days for sugar pill.

Additional Clinical Trial Results

In the same studies, a tool used by a doctor that measures obsessive binge eating thoughts and compulsive binge eating behaviors related to B.E.D. - the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating, or Y-BOCS-BE - was used. At the final visit of each of the 12-week studies, patients taking Vyvanse had a greater decrease in obsessive and compulsive thoughts and behaviors about binge eating compared to patients taking a sugar pill.

4-Week Time Period with No Binge Eating Episodes

In the two clinical studies, the percentage of patients who had no binge-eating episodes in the last 4 weeks of the studies was measured. This was defined as a patient who experienced no binge-eating episodes during the 4 weeks leading up to the patients' last visit of the study. Patients taking Vyvanse were more likely to have no binge eating episodes during this 4-week time period compared to patients taking a sugar pill.

Doctors’ Rating of Improvement

In the two studies, doctors also rated patients as much improved or very much improved ("improved"), or not improved, using the Clinical Global Impressions-Improvement rating scale. In Study 1, of patients treated with Vyvanse, 82% were rated "improved" and 18% rated "not improved." Of patients treated with a sugar pill, 47% were rated "improved" and 53% rated "not improved." In Study 2, of patients treated with Vyvanse, 86% were rated "improved" and 14% rated "not improved." Of patients treated with a sugar pill, 43% were rated "improved" and 57% were rated "not improved."

It is important to talk to your doctor to see if Vyvanse may be right for you, as medicine is not right for all adults with B.E.D.

Important Information About Vyvanse
Some people have had the following problems when taking stimulant medicines, such as Vyvanse. Tell the doctor:
 
  • if you have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects taking stimulant medicines, and sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
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Getting Started with Vyvanse

Vyvanse is a once-daily capsule that should be taken in the morning, with or without food, exactly as your doctor tells you to take it.

Vyvanse is available in 7 dosage strengths, including 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. 

Your doctor will determine the dose that is right for you. In clinical studies, adult patients with moderate to severe B.E.D. began treatment at 30 mg per day, and by week 4 were treated with 50 mg or a maximum dose of 70 mg per day.

Your own treatment needs may be different. It’s important to work with your doctor to find the dose that is right for you.

Tell the doctor:

  • if you have kidney problems. Your doctor may lower your dose.
  • if you are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
  • if you are breastfeeding or plan to breastfeed. Do not breastfeed while taking Vyvanse. Talk to your doctor about the best way to feed your baby if you take Vyvanse.
Vyvanse is a once-a-day capsule that should be taken in the morning, with or without food, exactly as your doctor tells you to take it. Tell your doctor if you have kidney problems. Your doctor may lower your dose. Also, tell your doctor if you are pregnant, breast-feeding or plan to become pregnant or breast-feed. Vyvanse is a once-a-day capsule that should be taken in the morning, with or without food, exactly as your doctor tells you to take it. Tell your doctor if you have kidney problems. Your doctor may lower your dose. Also, tell your doctor if you are pregnant, breast-feeding or plan to become pregnant or breast-feed.
It's Important to Work With Your Doctor

Take Vyvanse exactly as your doctor tells you to take it. Before starting treatment with Vyvanse for moderate to severe B.E.D., tell your doctor about all health conditions, or a family history of any health conditions. Vyvanse is a stimulant medicine. Tell the doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Tell the doctor:

  • if you have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects taking stimulant medicines, and sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
  • if you have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • if you have circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Vyvanse.

Vyvanse is a stimulant medicine. Prescription stimulant medications are controlled substances (regulated by the federal government) and need to be handled in a serious manner because they have a high risk of abuse and dependence. That's why it's important to understand the appropriate use of stimulants. Learn more about the proper use of stimulant medications.

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IMPORTANT SAFETY INFORMATION

Vyvanse® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others and is against the law.

Vyvanse is a stimulant medicine. Tell the doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Who should not take Vyvanse?

Do not take Vyvanse if you or your child are:

  • taking or has taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the past 14 days.
  • sensitive or allergic to, or had a reaction to other stimulant medicines.

Problems that can occur while taking Vyvanse. Tell the doctor:

  • if you or your child have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects taking stimulant medicines, and sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
  • if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • if you or your child have circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Vyvanse.
  • if your child is having slowing of growth (height and weight); Vyvanse may cause this serious side effect. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
  • if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
  • if you or your child are breastfeeding or plan to breastfeed. Do not breastfeed while taking Vyvanse. Talk to your doctor about the best way to feed your baby if you take Vyvanse.

What are possible side effects of Vyvanse?

The most common side effects of Vyvanse reported in ADHD studies include:

    • anxiety
    • decreased appetite
    • diarrhea
    • dizziness
    • dry mouth
    • irritability
    • loss of appetite
    • nausea
    • trouble sleeping
    • upper stomach pain
    • vomiting
    • weight loss

The most common side effects of Vyvanse reported in adults with moderate to severe BED include:

    • dry mouth
    • trouble sleeping
    • decreased appetite
    • increased heart rate
    • constipation
    • feeling jittery
    • anxiety

What is Vyvanse?

Vyvanse® (lisdexamfetamine dimesylate) is a prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


  • if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
  • if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
  • if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
  • if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
  • if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
  • if you or your child are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.