Key Topics

Vyvanse (lisdexamfetamine dimesylate) and Your Child

Vyvanse was shown to improve attention and reduce the symptoms of hyperactivity and impulsivity in children ages 6 to 17 with ADHD. In kids ages 6 to 12 with ADHD, Vyvanse provided ADHD symptom control throughout the day and into the evening.  Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

Clinical Trials

Studies in Kids (Ages 6 to 12)

In one study in kids ages 6 to 12:

  • When taken at 7 am, Vyvanse provided ADHD symptom control at 8:30 am.* 
  • Vyvanse demonstrated ADHD symptom control throughout the day and into the evening — even at 8 pm.* 

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

In another clinical study in kids ages 6 to 12:

  • Parents reported symptom improvement in the morning, in the afternoon, and into the early evening.

Based on Conners’ Parent Rating Scale

Duration of ADHD symptom control has not been studied in teens.

Studies in Teens (Ages 13 to 17)

In one study of teens with ADHD ages 13 to 17, Vyvanse was shown to improve the symptoms of ADHD in a 4-week clinical study.

  • Vyvanse was shown to improve attention and reduce the symptoms of hyperactivity and impulsivity. 

Based on the ADHD Rating Scale IV (ADHD-RS-IV) Total Score

Who should not take Vyvanse (lisdexamfetamine dimesylate)

Your child should not take Vyvanse if he or she:

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

Vyvanse for Maintenance Treatment

Children (Ages 6 to 17)

In 2013, Vyvanse was approved by the FDA for maintenance treatment in children (ages 6 to 17):

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

A study in children with ADHD who took Vyvanse for at least 6 months and whose symptoms were well controlled evaluated the benefit of extended treatment with Vyvanse.

During the first 4 weeks of the study, children were started on a dose of Vyvanse; the dose was adjusted as needed for the next 20 weeks. After 2 weeks of observation without any changes to the dose, children were randomly placed in 1 of 2 groups: half of the children continued to take Vyvanse while the other half were switched to placebo (sugar pill).

At the end of the study:

  • 84.2% of children maintained ADHD symptom control with Vyvanse, compared to 32.5% with a sugar pill.*

The study found that 84.2% of children maintained symptom control with Vyvanse compared to 32.5% with a sugar pill*

    *Treatment failure was defined as ≥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

Your child should take Vyvanse exactly as the doctor tells him or her to take it.

Before starting Vyvanse and during treatment, tell your child's 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 your child has any kidney problems. Your child's doctor may lower the dose
  • If your child is pregnant, breast-feeding, or planning to become pregnant or breast-feed, and about any medications (prescription or non-prescription) that your child is taking
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Common Questions About Vyvanse

  • What is the recommended Vyvanse (lisdexamfetamine dimesylate) dosage?

    The doctor will work with your child to find the dosage that works best—increasing it if your child’s symptoms aren’t well controlled or decreasing it if your child experiences side effects. It may require time to determine which dose of medication is right for your child.

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

    It’s important that your child takes Vyvanse exactly as the doctor tells him or her to take it. And it’s also important to keep talking with the doctor while your child is taking Vyvanse. If your child takes too much Vyvanse, call your doctor or poison control center right away, or get to the nearest hospital emergency room.

    See additional dosing information  

  • Is there another way to take Vyvanse if my child has trouble swallowing pills?

    Yes. If your child has trouble swallowing capsules, open the Vyvanse capsule and pour all the powder into yogurt, water, or orange juice. 

    • Use all of the Vyvanse powder from the capsule so your child gets all of the medicine.
    • Using a spoon, break apart any powder that is stuck together. Stir the Vyvanse powder and yogurt, water, or orange juice until they are completely mixed together.
    • Your child should eat all the yogurt or drink all the water or orange juice right away after it has been mixed with Vyvanse. Do not store the yogurt, water, or orange juice after it has been mixed with Vyvanse. It is normal to see a filmy coating on the inside of the glass or container after your child eats or drinks all the Vyvanse. 

    See additional dosing information

    Mix in yogurt | Mix in orange juice | Mix in water | Consume whole
  • How soon does Vyvanse (lisdexamfetamine dimesylate) start working and how long does it last?

    • In a clinical trial of kids ages 6-12 with ADHD, Vyvanse was shown to start working 1.5 hours after taking the medication.* Vyvanse was shown to be effective for ADHD symptoms 13 hours after the morning dose.
    • The onset and duration of Vyvanse in teens (13-17) have not been studied.

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

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

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

    Your child’s doctor or health care provider can determine the best course of treatment for your child. Make sure you talk with the doctor before stopping or changing the dose of your child’s medication. 
  • How should Vyvanse treatment be discontinued?

    Only the doctor can determine the proper course of treatment for your child, including when to start or whether to stop Vyvanse. Your child’s doctor may sometimes stop Vyvanse treatment for a while to check his or her ADHD symptoms. Talk to your child’s doctor before stopping Vyvanse.

  • Who should not take Vyvanse?

    Your child should not take Vyvanse (lisdexamfetamine dimesylate) if he or she:

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

    Vyvanse (lisdexamfetamine dimesylate) may not be right for everyone. Your child should take Vyvanse exactly as the doctor tells him or her to take it. Get a complete list of side effects.

  • What should I tell my child’s doctor before starting Vyvanse?

    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 your child has any kidney problems. Your child's doctor may lower the dose
    • If your child is pregnant, breast-feeding, or planning to become pregnant or breast-feed, and about any medications (prescription or non-prescription) that your child is taking

  • What are side effects of Vyvanse?

    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 below.
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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.