How should Vyvanse (lisdexamfetamine) be prescribed for a patient with suspected ADHD or binge eating disorder?

Vyvanse (Lisdexamfetamine) Prescribing Guidelines

FDA-Approved Indications

Vyvanse is FDA-approved for two specific conditions: ADHD in patients 6 years and older, and moderate to severe binge eating disorder (BED) in adults. 1

ADHD Treatment

• Start at 30 mg once daily in the morning for both adults and pediatric patients 6 years and older 1
• Titrate in increments of 10 mg or 20 mg at approximately weekly intervals up to a maximum of 70 mg once daily 1
• Avoid afternoon doses due to insomnia risk 1
• The medication can be taken with or without food 1

Binge Eating Disorder Treatment

• Start at 30 mg once daily in adults 1
• Titrate in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50-70 mg once daily 1
• Maximum dose is 70 mg once daily 1
• The 50 mg and 70 mg doses demonstrated superior efficacy compared to placebo, with effect sizes of 0.83-0.97 2, 3
• Number needed to treat (NNT) for response is 3, and NNT for remission (4-week binge cessation) is 4 3

Critical Pre-Treatment Screening

Before prescribing Vyvanse, you must assess:

• Cardiac disease history: Perform careful personal and family history of sudden death or ventricular arrhythmia, plus physical examination 1
• Motor or verbal tics or Tourette's syndrome: Evaluate family history and clinically assess the patient 1
• Risk for abuse, misuse, and addiction: This is a Schedule II controlled substance with high abuse potential 1
• Contraindications: Uncontrolled hypertension, coronary artery disease, tachyarrhythmias, or active substance use disorders 4

Administration Options

Vyvanse can be administered in two ways 1:

1. Swallow capsules whole
2. Open capsules and mix entire contents with yogurt, water, or orange juice; consume immediately (do not store)

Never divide a single dose—one capsule or chewable tablet per day minimum 1

Maximum Dose Limitations

The FDA-approved maximum dose is 70 mg daily—exceeding this dramatically amplifies cardiovascular and psychiatric risks without proven therapeutic benefit 5, 1

• Doses above 70 mg may cause significant cardiovascular toxicity, including dose-dependent increases in blood pressure and heart rate 5
• If inadequate response at 70 mg, reevaluate the diagnosis rather than increasing the dose 5
• Consider switching to alternative medications (Adderall or methylphenidate-based agents) if 70 mg is insufficient 5

Monitoring Requirements

Initial and Ongoing Monitoring

• Vital signs: Blood pressure, heart rate, and orthostatic changes 6
• Weight: Monitor for weight loss, particularly in pediatric patients under 6 years who experience more long-term weight loss 1
• Common adverse effects (NNH values vs placebo): Dry mouth (NNH=4), decreased appetite (NNH=11), insomnia (NNH=11), headache (NNH=19) 3
• Cardiovascular effects: Monitor throughout treatment 4
• Signs of abuse, misuse, or addiction: Reassess frequently 1

BED-Specific Monitoring

• Binge eating days per week: Track reduction from baseline 2
• Weight changes: Mean weight loss of 4.3-4.9 kg observed in clinical trials at 50-70 mg doses 2
• Global improvement: Assess using Clinical Global Impressions-Improvement scores 3

Special Populations and Considerations

Pediatric Patients

• Not recommended for children under 6 years due to greater long-term weight loss 1
• For children 6 years and older with ADHD, follow the same dosing as adults (start 30 mg, titrate to max 70 mg) 1

Pregnancy and Lactation

• Lisdexamfetamine crosses the placenta in animal models 6
• Weigh risks of medication exposure against risks of untreated ADHD, which is associated with increased spontaneous abortion and preterm birth 6
• Hale lactation risk category: L3 6

Binge Eating Disorder Context

• Lisdexamfetamine is the only FDA-approved medication for BED 6, 7, 8
• It significantly reduces binge eating episodes and improves obsessive-compulsive symptoms related to eating 6
• Not indicated for weight loss or obesity treatment—use of sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events 1

When to Consider Alternatives

If switching from Vyvanse to another amphetamine (e.g., Adderall) is needed 4:

• Use direct switch (no washout period required) 4
• Approximate dose conversion: 30 mg Vyvanse ≈ 10 mg Adderall; 50 mg Vyvanse ≈ 15-20 mg Adderall; 70 mg Vyvanse ≈ 20-30 mg Adderall 4
• Monitor closely during first 1-2 weeks for side effects and symptom control 4

Consider methylphenidate-based medications (Ritalin, Concerta) if amphetamine side effects are problematic, as they have different mechanisms and side effect profiles 4

Critical Safety Warnings

Boxed Warning: Abuse, Misuse, and Addiction

Vyvanse has high potential for abuse and misuse, which can lead to substance use disorder, including addiction 1:

• Misuse and abuse can result in overdose and death 1
• Risk increases with higher doses or unapproved administration methods (snorting, injection) 1
• Educate patients and families about proper storage and disposal 1

Contraindications and Precautions

• Avoid in patients with uncontrolled hypertension, coronary artery disease, tachyarrhythmias 4, 5
• Stimulants are not first-line for depression and may precipitate mania in undiagnosed bipolar disorder 5
• Discontinuation due to adverse events is uncommon (NNH=44) 3

Clinical Efficacy Data

ADHD

• Methylphenidate is recommended as first-line treatment in most Asian guidelines, with lisdexamfetamine as an alternative or third-line option 6
• In Japan, lisdexamfetamine is approved with a maximum dose of 70 mg daily 6

Binge Eating Disorder

• 50 mg and 70 mg doses significantly reduced binge eating days per week compared to placebo (p<0.001 for 70 mg) 2
• 4-week binge cessation rates: 50% with 70 mg vs 21.3% with placebo 2
• Mean reduction in binge eating days: -4.1 days/week for both 50 mg and 70 mg doses 2
• Long-term studies (up to 52 weeks) show sustained efficacy and marked reduction in relapse risk 7