Vyvanse may help control ADHD in adults

ADHD Symptom Control Matters

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Vyvanse Clinical Study Results

In clinical studies, Vyvanse improved attention and reduced the symptoms of hyperactivity and impulsivity in adults with ADHD. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

In a Study of Adults with ADHD, Vyvanse Improved Attention at 2 Hours and Even 14 Hours After Taking It.

Understanding the research

The Study

In a Study of Adults with ADHD Vyvanse Improved Attention at 2 Hours and Even 14 Hours After Taking It. Understanding the research. The Study – Study Population: 142 adults aged 18 to 55 with ADHD. Dose Selection – For the first four weeks, everyone in the study took Vyvanse. Researchers adjusted the dose as needed to find the right dose for each person. Study groups – At the beginning of the 5th week, half of the group continued to take Vyvanse. The other half switched to a sugar pill (placebo). Researchers and study subjects didn’t know who got Vyvanse and who got the sugar pill. Study setting – At the end of the 5th week, during a single day both groups were placed in a classroom-like setting designed to resemble the workplace environment. Testing – At 7am, everyone took their assigned medication – either Vyvanse or the sugar pill. Next they began a schedule of general activities that were designed to keep study subjects busy and bring out symptoms of ADHD. After each set of activities, subjects were given a timed test* commonly used by researchers to measure attention in ADHD. Tests were given over 14 hours at 9am, 11am, 3pm, 5pm, 7pm; the last test was at 9pm. (*Permanent Product Measure of Performance (PERMP) is a skill-adjusted test that measures attention in ADHD.) Testing repeated – At the beginning of the 6th week, the group that had taken Vyvanse was switched to the sugar pill and the group that had taken the sugar pill was switched to Vyvanse. At the end of the 6th week, study subjects were again given the timed tests under the same conditions. Measures – Attention was measured by using the groups’ average test scores throughout the day when taking Vyvanse compared to when taking sugar pill. Higher scores indicated improved attention. Study results – The average of all test scores throughout the day was higher when Vyvanse was taken. Vyvanse improved attention throughout the day for each time point tested, starting at 2 hours and even at 14 hours after taking it. In a Study of Adults with ADHD Vyvanse Improved Attention at 2 Hours and Even 14 Hours After Taking It. Understanding the research. The Study – Study Population: 142 adults aged 18 to 55 with ADHD. Dose Selection – For the first four weeks, everyone in the study took Vyvanse. Researchers adjusted the dose as needed to find the right dose for each person. Study groups – At the beginning of the 5th week, half of the group continued to take Vyvanse. The other half switched to a sugar pill (placebo). Researchers and study subjects didn’t know who got Vyvanse and who got the sugar pill. Study setting – At the end of the 5th week, during a single day both groups were placed in a classroom-like setting designed to resemble the workplace environment. Testing – At 7am, everyone took their assigned medication – either Vyvanse or the sugar pill. Next they began a schedule of general activities that were designed to keep study subjects busy and bring out symptoms of ADHD. After each set of activities, subjects were given a timed test* commonly used by researchers to measure attention in ADHD. Tests were given over 14 hours at 9am, 11am, 3pm, 5pm, 7pm; the last test was at 9pm. (*Permanent Product Measure of Performance (PERMP) is a skill-adjusted test that measures attention in ADHD.) Testing repeated – At the beginning of the 6th week, the group that had taken Vyvanse was switched to the sugar pill and the group that had taken the sugar pill was switched to Vyvanse. At the end of the 6th week, study subjects were again given the timed tests under the same conditions. Measures – Attention was measured by using the groups’ average test scores throughout the day when taking Vyvanse compared to when taking sugar pill. Higher scores indicated improved attention. Study results – The average of all test scores throughout the day was higher when Vyvanse was taken. Vyvanse improved attention throughout the day for each time point tested, starting at 2 hours and even at 14 hours after taking it.
Study Results

The average of all test scores throughout the day was higher when Vyvanse was taken.

Vyvanse improved attention throughout the day for each time point tested, starting at 2 hours and even at 14 hours after taking it.

Vyvanse Is the Only ADHD Medication Approved for Maintenance Treatment in Adults. Adults with ADHD taking Vyvanse for at least 6 months and whose symptoms were well controlled entered a study to evaluate the benefit of extended treatment with Vyvanse. After 3 weeks of observation while on Vyvanse, half of the patients continued to take Vyvanse for the last 6 weeks of the study while the other half were switched to a sugar pill.  At the end of the 9-week study, 91% of people maintained ADHD symptom control with Vyvanse versus 25% with a sugar pill.* *Treatment failure was defined as a ≥50% increase (worsening) in the ADHD Rating Scale IV (ADHD-RS-IV) Total Score and ≥2-point increase in the Clinical Global Impression Severity (CGI-S) score compared to scores at entry into the double-blind phase.

Vyvanse is not for weight loss.  It is not known if Vyvanse is safe and effective for the treatment of obesity.

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-depression medicine called a monoamine oxidase inhibitor, or MAOI, or are sensitive to, allergic to, or had a reaction to other stimulant medications.

Vyvanse Is the Only ADHD Medication Approved for Maintenance Treatment in Adults

Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

Adults with ADHD taking Vyvanse for at least 6 months and whose symptoms were well controlled entered a study to evaluate the benefit of extended treatment with Vyvanse. After 3 weeks of observation while on Vyvanse, half of the patients continued to take Vyvanse for the last 6 weeks of the study while the other half were switched to a sugar pill.

At the end of the 9-week study, 91% of people maintained ADHD symptom control with Vyvanse versus 25% with a sugar pill.†

A Closer Look at Results from Last 6 Weeks of This Study

Vyvanse Is the Only ADHD Medication Approved for Maintenance Treatment in Adults. Adults with ADHD taking Vyvanse for at least 6 months and whose symptoms were well controlled entered a study to evaluate the benefit of extended treatment with Vyvanse. After 3 weeks of observation while on Vyvanse, half of the patients continued to take Vyvanse for the last 6 weeks of the study while the other half were switched to a sugar pill.  At the end of the 9-week study, 91% of people maintained ADHD symptom control with Vyvanse versus 25% with a sugar pill.* *Treatment failure was defined as a ≥50% increase (worsening) in the ADHD Rating Scale IV (ADHD-RS-IV) Total Score and ≥2-point increase in the Clinical Global Impression Severity (CGI-S) score compared to scores at entry into the double-blind phase.

†Treatment failure was defined as a ≥50% increase (worsening) in the ADHD Rating Scale IV (ADHD-RS-IV) Total Score and ≥2-point increase in the Clinical Global Impression Severity (CGI-S) score compared to scores at entry into the double-blind phase.

Vyvanse (lisdexamfetamine dimesylate) May Not Be Right for Everyone

Vyvanse should be taken exactly as prescribed by your doctor. Before starting Vyvanse and during treatment, tell your doctor about all health conditions (or family history of) including:

  • Any previous or current abuse or dependency on alcohol, prescription medicine or street drugs
  • Heart problems, heart defects, or high blood pressure
  • Mental problems, including psychosis, mania, bipolar illness, or depression
  • Circulation problems in fingers and toes
  • If you have any kidney problems. Your doctor may lower the dose
  • If you are pregnant, breast-feeding, or planning to become pregnant or breast-feed, and about any medications (prescription or non-prescription) that you are taking

See additional Safety Information below.

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Common Questions About Vyvanse

  • Who should not take Vyvanse?

    You should not take Vyvanse (lisdexamfetamine dimesylate) if you:

    • Are taking or have taken within the past 14 days an anti-depressant called a monoamine oxidase inhibitor (MAOI)
    • Are sensitive to, allergic to, or had a reaction to other stimulant medications
    Vyvanse (lisdexamfetamine dimesylate) may not be right for everyone. You should take Vyvanse exactly as the doctor tells you to take it. Get a complete list of side effects.
  • What are side effects of Vyvanse (lisdexamfetamine dimesylate)?

    Vyvanse may cause serious cardiovascular, mental (psychiatric), and circulatory side effects. Vyvanse may also cause the slowing of growth (height and weight) in children. The most common side effects of Vyvanse include anxiety, decreased appetite, diarrhea, dizziness, dry mouth, irritability, loss of appetite, nausea, trouble sleeping, upper stomach pain, vomiting, and weight loss. These are not all the possible side effects of Vyvanse.

    For more information, ask your doctor or pharmacist and see Important Safety Information.

  • What is the recommended Vyvanse dosage?

    Your doctor will work with you to find the dosage that works best — increasing it if your symptoms aren’t well controlled or decreasing it if you experience side effects.

    You should take Vyvanse once a day in the morning. Vyvanse capsules should be swallowed whole — and taken with or without food.

    It’s important that you take Vyvanse exactly as the doctor tells you to take it. And it's also important to keep talking to your doctor about your progress on Vyvanse. If you take too much Vyvanse, call your doctor or poison control center right away, or get to the nearest hospital emergency room.

    See additional dosing information

  • Why is the doctor changing the dosage of my ADHD medicine?

    The doctor may adjust the dosage of your medication. It may require time to determine which dose of medication is right for you. It's important that you take Vyvanse exactly as the doctor tells you to take it.

    See additional dosing information
  • How soon does Vyvanse (lisdexamfetamine dimesylate) start working and how long does it last?

    In an adult clinical trial, Vyvanse was shown to start working 2 hours and 14 hours after taking the medication. Everyone is different, so it may take some time for the doctor to find the right dose for you. The onset and duration of Vyvanse in adolescents have not been studied. However, in a clinical trial of children aged 6-12, Vyvanse was shown to start working 1.5 hours after taking the medication.§

    Based on the Permanent Product Measure of Performance (PERMP), a skill-adjusted test that measures attention in ADHD. 

    §Based on Swanson, Kotkin, Agler, M. Flynn, and Pelham Deportment Scores (SKAMP-DS).

    Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

    Please talk to your doctor if you have any questions about Vyvanse.

    ADHD is a treatable medical condition

  • Can Vyvanse be stopped on weekends or for “drug holidays”?

    Your doctor or health care provider can determine the best course of treatment for you. Take Vyvanse exactly as prescribed and talk to your doctor before stopping or changing the dose of your medication. 
  • How should Vyvanse treatment be discontinued?

    Only the doctor can determine the proper course of treatment for you, including when to start or whether to stop Vyvanse. Make sure you talk with your doctor before stopping or changing the dose of your medication. Your doctor may sometimes stop Vyvanse treatment for a while to check your ADHD symptoms.
  • What information should I tell my doctor before starting Vyvanse (lisdexamfetamine dimesylate)?

    Before starting Vyvanse and during treatment, tell your doctor about all health conditions (or family history of) including:

    • Any previous or current abuse or dependency on alcohol, prescription medicine or street drugs
    • Heart problems, heart defects, or high blood pressure
    • Mental problems, including psychosis, mania, bipolar illness, or depression
    • Circulation problems in fingers and toes
    • If you have any kidney problems. Your doctor may lower the dose
    • If you are pregnant, breast-feeding, or planning to become pregnant or breast-feed, and about any medications (prescription or non-prescription) that you are taking
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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 is:

  • 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, and sudden death, stroke and heart attack have happened in adults. 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, breast-feeding, or plan to become pregnant or breast-feed.

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 studies of adults with moderate to severe B.E.D. 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.