Brand name: Vyvanse
Drug class: Amphetamines

Medically reviewed by Drugs.com on Aug 10, 2025. Written by ASHP.

Introduction

Prodrug of dextroamphetamine; noncatecholamine, sympathomimetic amine with CNS-stimulating activity.

Uses for Lisdexamfetamine

Attention-Deficit/Hyperactivity Disorder

Used orally for the treatment of ADHD in adults and pediatric patients ≥6 years of age.

American Academy of Pediatrics (AAP) states that, for pediatric patients 6–12 years of age with ADHD, provider should prescribe FDA-approved medications for ADHD, in addition to parent training in behavior management (PTBM) and/or behavioral classroom interventions. Evidence is stated as particularly strong for stimulant medications (e.g., amphetamines, methylphenidate). For adolescents 12–18 years of age with ADHD, provider should prescribe FDA-approved medications with assent of the adolescent. Provider is also encouraged to prescribe behavioral and other evidence-based training interventions if available. Titrate doses of medications to achieve maximum benefit with tolerable side effects.

Treatment of ADHD in adults should follow a multimodal approach that includes psychoeducation, pharmacotherapy, cognitive behavior therapy, and coaching for ADHD. First-line pharmacotherapy agents include long-acting stimulants such as mixed amphetamine salts, methylphenidate, and lisdexamfetamine.

Binge-Eating Disorder (BED)

Used orally for the treatment of moderate to severe BED in adults. Not indicated for weight loss. Use of other sympathomimetic drugs for weight loss associated with serious adverse cardiovascular adverse events. Efficacy and safety of lisdexamfetamine for the treatment of obesity not established.

American Psychiatric Association (APA) recommends that patients with BED be treated with eating disorder-focused cognitive-behavioral therapy (CBT) or interpersonal therapy, in either a group or an individual format. For adults who have not responded to psychotherapy alone or who prefer medication, APA suggests treatment with either an antidepressant medication or lisdexamfetamine.

Autism Spectrum Disorder (ASD)

Has been used for the symptomatic treatment of inattention, impulsivity, and hyperactivity in pediatric patients with ASD^{† [off-label]}.

Guidelines from AAP suggest use of psychostimulants (e.g., methylphenidate, dexmethylphenidate, mixed amphetamine salts, lisdexamfetamine, dextroamphetamine) for symptoms of hyperactivity, impulsivity, inattention, and distractibility in pediatric patients with ASD if problems persist after behavioral interventions. Patients should start with a low dose, with increases as needed and tolerated. Stimulants may be most effective in children who do not have a comorbid intellectual disability.

Lisdexamfetamine Dosage and Administration

General

Pretreatment Screening

• Evaluate patients for risk of abuse, misuse, and addiction prior to initiation of CNS stimulant therapy.

• Children, adolescents, and adults being considered for stimulant therapy should undergo a thorough medical history review (including evaluation for a family history of sudden death or ventricular arrhythmia) and physical examination to detect the presence of cardiac disease.

• Prior to initiating stimulant therapy, carefully screen patients with attention deficit hyperactivity disorder (ADHD) to determine if they are at risk for developing a manic episode; such screening should include a detailed psychiatric history (e.g., current or prior depressive symptoms; family history of suicide, bipolar disorder, or depression).

• Prior to initiation of therapy, assess for family history of motor or verbal tics or Tourette’s syndrome, and clinically evaluate patients for such disorders.

Patient Monitoring

• Routinely monitor patients receiving stimulant therapy for the emergence or worsening of tics or Tourette’s syndrome.

• Closely monitor growth (weight and height) in pediatric patients receiving stimulant therapy.

• Throughout treatment, reassess each patient’s risk of abuse, misuse, and addiction. Frequently monitor for signs of abuse, misuse, and addiction during treatment.

• Monitor for hypertension and tachycardia.

Dispensing and Administration Precautions

Handling and Disposal

• Lisdexamfetamine should be disposed of by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site when it is no longer needed. If there is no take-back program or authorized DEA collection site available, the drug can be mixed with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds and disposed of in a sealed plastic bag in the household trash.

Administration

Oral Administration

Administer capsules or chewable tablets once daily in the morning without regard to meals. Because of potential for insomnia, avoid administering in the afternoon.

Swallow capsules whole.

Alternatively, capsule may be opened and entire contents mixed with water, orange juice, or yogurt until completely dispersed; administer resulting mixture immediately. Do not store mixture for use at later time.

Do not subdivide capsule contents; do not administer a dose less than the entire contents of one capsule or one chewable tablet.

Chew tablets thoroughly before swallowing.

Capsules can be substituted for chewable tablets on a mg-per-mg basis.

Dosage

Available as lisdexamfetamine dimesylate; dosage expressed in terms of the salt.

Pediatric Patients

ADHD

Oral

Children and adolescents ≥6 years of age: Initially, 30 mg once daily; dosage may be adjusted in 10- or 20-mg increments at weekly intervals to a maximum of 70 mg daily.

Adults

ADHD

Oral

Initially, 30 mg once daily; dosage may be adjusted in 10- or 20-mg increments at weekly intervals to a maximum of 70 mg daily.

Binge-Eating Disorder

Oral

Initially, 30 mg once daily; adjust dosage in 20-mg increments at weekly intervals to target dosage of 50–70 mg daily. Maximum dosage is 70 mg daily.

Discontinue drug if binge eating does not improve.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

Severe renal impairment (GFR 15 to <30 mL/minute per 1.73 m²): Maximum 50 mg daily. End-stage renal disease (ESRD) (GFR <15 mL/minute per 1.73 m²): Maximum 30 mg daily.

Geriatric Patients

No specific dosage recommendations. Dosage should generally start on lower end of dosing range, reflecting greater incidence of reduced hepatic, renal, or cardiac function, and of concomitant diseases and drug therapies.

Cautions for Lisdexamfetamine

Contraindications

• Known hypersensitivity to amphetamines or any ingredient in the formulation of lisdexamfetamine dimesylate. Anaphylactic reactions, hypersensitivity, Stevens-Johnson syndrome, angioedema, and urticaria have been reported during postmarketing surveillance of lisdexamfetamine.

• Concurrent or recent (i.e., within 14 days) therapy with a MAO inhibitor, including linezolid or IV methylene blue, since hypertensive crisis could result.

Warnings/Precautions

Warnings

Abuse, Misuse, and Addiction

Potential for abuse, misuse, and addiction (see Boxed Warning). Assess risk of abuse, misuse, and addiction prior to initiation of lisdexamfetamine and monitor patients for signs of abuse, misuse, and addiction during therapy. Misuse and abuse can lead to overdose and death. This risk is increased at higher dosages or with unapproved routes of administration (i.e., snorting, injection).

Other Warnings and Precautions

Risks to Patients with Serious Cardiac Disease

Sudden unexplained death reported in patients with structural cardiac abnormalities or other serious cardiac disease receiving usual dosages of stimulants for ADHD.

Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy.

Avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.

Patients who develop exertional chest pain, unexplained syncope, arrhythmias, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.

Increased BP and Heart Rate

Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur. Monitor all patients for changes in BP and heart rate.

Psychiatric Adverse Reactions

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.

Psychotic or manic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness or mania. If psychotic or manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.

May precipitate mixed or manic episodes in patients with bipolar disorder. Prior to initiating therapy, carefully screen patients for risk factors for developing a manic episode; with screening, include a detailed psychiatric history (e.g., comorbid depressive symptoms or history of depressive symptoms; family history of suicide, bipolar disorder, or depression).

Long-term Suppression of Growth in Pediatric Patients

Administration of stimulants in children associated with growth suppression (height and weight). Dose-related weight loss reported in children and adolescents during 4 weeks of therapy with lisdexamfetamine.

Manufacturer recommends closely monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.

Peripheral Vasculopathy, including Raynaud's Phenomenon

Peripheral vascular disorders (e.g., Raynaud's phenomenon) reported in patients in all age groups receiving stimulants at therapeutic dosages and at various times throughout treatment course. Manifestations usually intermittent and mild, but ulceration of digits and/or breakdown of soft tissue occur rarely. Carefully observe patients for digital changes.

Improvement generally observed following dosage reduction or drug discontinuance; patients with signs or symptoms of peripheral vasculopathy may require further evaluation (e.g., referral to rheumatologist).

Serotonin Syndrome

Potentially life-threatening serotonin syndrome may occur when amphetamines are used concomitantly with other drugs that affect serotonergic neurotransmission (e.g., MAO inhibitors, SSRIs, SNRIs, tricyclic antidepressants, 5-hydroxytryptamine [5-HT] type 1 receptor agonists [“triptans”], buspirone, fentanyl, lithium, tramadol, tryptophan, St. John's wort [Hypericum perforatum]). May also occur when lisdexamfetamine and CYP2D6 inhibitors are used concomitantly.

Symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, coma), autonomic instability (e.g., tachycardia, labile BP, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular aberrations (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, GI symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of lisdexamfetamine and MAOIs contraindicated.

If concomitant therapy with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, consider lower initial lisdexamfetamine dosage and monitor patient for emergence of serotonin syndrome, particularly during initiation of therapy and dosage increases.

If symptoms of serotonin syndrome occur, discontinue lisdexamfetamine and any other concomitant serotonergic agents immediately and initiate supportive therapy.

Motor and Verbal Tics and Worsening of Tourette's Syndrome

Onset or exacerbation of motor or verbal tics and worsening of Tourette’s syndrome reported.

Prior to initiation, screen patients for a family history and clinically evaluate for motor or verbal tics or Tourette’s syndrome. Routinely monitor patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically needed.

Specific Populations

Pregnancy

National Pregnancy Registry for ADHD Medications available at [Web].

Only limited data available in pregnant women. Amphetamines may decrease placental perfusion through vasoconstriction and stimulate uterine contractions, increasing the risk of premature delivery. Risk of prematurity and low birth weight in infants born to amphetamine-dependent women; monitor such infants for withdrawal symptoms (e.g., feeding difficulties, irritability, agitation, excessive drowsiness).

In animals, no effects on embryofetal morphology or survival when lisdexamfetamine administered throughout organogenesis. Prenatal and postnatal studies not conducted specifically with lisdexamfetamine. Administration of amphetamine to pregnant rats during gestation and lactation resulted in decreased pup survival and body weight correlating with developmental delays at clinically relevant dosages of amphetamine.

Lactation

Distributed into human milk based on limited case reports. No reports of adverse effects on breast-feeding infants; long-term neurodevelopmental effects from exposure not known. Large dosages of dextroamphetamine may interfere with milk production, especially in women whose lactation is not well established. Because of potential for serious adverse effects to lisdexamfetamine in breast-feeding infants (e.g., BP and heart rate increases, growth suppression, peripheral vasculopathy), breast-feeding not recommended during therapy.

Pediatric Use

ADHD: Safety and efficacy not established in pediatric patients <6 years of age.

Binge-eating disorder: Safety and efficacy not established in pediatric patients <18 years of age.

Psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.

Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults. Differences not identified with other reported clinical experience in responses between geriatric and younger adults.

Hepatic Impairment

Not specifically studied in hepatic impairment.

Renal Impairment

Reduced clearance observed in patients with severe renal impairment or ESRD.

Dosage adjustment recommended in severe renal impairment (GFR 15 to <30 mL/minute per 1.73 m²) or ESRD (GFR <15 mL/minute per 1.73 m²).

Lisdexamfetamine is not removed by dialysis.

Common Adverse Effects

Children, adolescents, or adults with ADHD (≥5% and at least twice that of placebo): Anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, vomiting.

Adults with binge-eating disorder (≥5% and at least twice that of placebo): Dry mouth, insomnia, decreased appetite, increased heart rate, constipation, jittery feeling, anxiety.

Drug Interactions

The prodrug lisdexamfetamine not metabolized by CYP isoenzymes before its conversion to dextroamphetamine.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

CYP2D6 inhibitors: Potential pharmacokinetic interaction (increased exposure to dextroamphetamine); may increase risk of serotonin syndrome. Consider alternative therapy with a non-serotonergic drug or drug that does not inhibit CYP2D6.

If concomitant therapy is clinically warranted, use lower dosages of lisdexamfetamine during initiation of therapy. Monitor patients for signs and symptoms of serotonin syndrome, especially when therapy is initiated or dosage increased.

If serotonin syndrome occurs, discontinue lisdexamfetamine and the CYP2D6 inhibitor.

No clinically important interactions shown with lisdexamfetamine and substrates of CYP1A2 (e.g., duloxetine, melatonin, theophylline), 2D6 (e.g., atomoxetine, desipramine, venlafaxine), 2C19 (e.g., clobazam, lansoprazole, omeprazole), or 3A4 (e.g., midazolam, pimozide, simvastatin).

Serotonergic Drugs

Potential pharmacologic interaction (potentially life-threatening serotonin syndrome) with serotonergic drugs.

If concomitant therapy is clinically warranted, use lower dosages of lisdexamfetamine during initiation of therapy. Monitor patients for signs and symptoms of serotonin syndrome, especially when therapy is initiated or dosage increased.

If serotonin syndrome occurs, discontinue lisdexamfetamine and the concomitant serotonergic drug(s).

Specific Drugs

Lisdexamfetamine Pharmacokinetics

Absorption

Bioavailability

Capsules: peak plasma concentrations of lisdexamfetamine occur in approximately 1 hour; concentrations are low and transient and become nonquantifiable by 8 hours after administration. Peak plasma concentrations of dextroamphetamine occur in approximately 3.5 hours.

Chewable tablets: peak plasma concentrations of lisdexamfetamine occur at about 1 hour, and dextroamphetamine at 4.4 hours.

Peak plasma concentrations and AUC of lisdexamfetamine are reduced by about 15% with the chewable tablets compared to the capsules; however, exposure to dextroamphetamine is similar between products.

No accumulation of lisdexamfetamine or dextroamphetamine occurs at steady state in adults.

Food

Capsules: administration with food (high-fat meal or yogurt) delays time to peak plasma concentration of dextroamphetamine by about 1 hour, but administration with high-fat meal, yogurt, or orange juice does not affect magnitude of peak plasma concentration or AUC of dextroamphetamine.

Chewable tablets: administration with food (high-fat meal) delays time to peak plasma concentration of dextroamphetamine by about 1 hour, and decreases the AUC and magnitude of peak plasma concentrations by about 5−7%.

Distribution

Extent

Amphetamines are distributed into human milk.

Elimination

Metabolism

Lisdexamfetamine is converted to l-lysine and dextroamphetamine mainly via hydrolytic activity of RBCs, which have high capacity for this metabolism.

Lisdexamfetamine is not metabolized by CYP isoenzymes.

Elimination Route

Excreted principally in urine. Approximately 96% of a 70-mg radiolabeled oral dose of lisdexamfetamine was recovered in urine; parent drug accounted for about 2% of the recovered radioactivity.

Changes in urinary pH may alter excretion of amphetamines.

Half-life

Lisdexamfetamine: <1 hour (patients ≥6 years of age)

Dextroamphetamine: 8.6–9.5 hours (children 6−12 years of age); 10−11.3 hours (adults)

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 20–25°C (may be exposed to 15–30°C).

Chewable Tablets

Tight, light-resistant containers at 20–25°C (may be exposed to 15–30°C).

Actions

• Amphetamines are sympathomimetic amines with CNS stimulant activity.

• Exact mechanism of therapeutic action in ADHD and binge eating disorder not known.

• Lisdexamfetamine is a prodrug of dextroamphetamine; dextroamphetamine may block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Advice to Patients

• Provide the patient or caregiver with a copy of the manufacturer’s patient information (Medication Guide); discuss and answer questions about its contents as needed. Advise the patient or caregiver to read and understand contents of Medication Guide before initiating therapy and each time the prescription is refilled.

• Inform patients about the risks of abuse, misuse, and addiction with lisdexamfetamine, which can lead to overdose and death. Advise patients on proper disposal of unused drug; advise them to store lisdexamfetamine in a safe, preferably locked place, and to not give the drug to anyone else.

• Advise patients to take the drug in the morning to minimize insomnia.

• Inform patients of the potential risks to patients with serious cardiac disease, including sudden death. Advise patients to immediately inform a clinician if they develop exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease.

• Risk of increased blood pressure and heart rate; advise patients to monitor blood pressure and heart rate during therapy.

• Advise patients of the risk of psychiatric effects (e.g., psychosis, mania), even in patients without a history of such effects.

• Risk of weight loss or decreased growth rate; monitor height and weight of pediatric patients during therapy.

• Inform patients that capsules may be taken whole, or they can be opened and contents mixed with yogurt, water, or orange juice. Advise patients to immediately consume the mixture and not store for later use if the capsules are opened.

• Inform patients that the chewable tablets must be chewed thoroughly before swallowing.

• Inform patients about the potential for amphetamines to impair their ability to perform potentially hazardous activities, such as driving or operating heavy machinery.

• Potential risk of peripheral vascular disorders, including Raynaud's phenomenon, and the associated signs and symptoms (e.g., numbness, coolness, pain, or changes in color [from pale to blue to red] in fingers or toes). Advise patients to report any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes and to immediately inform their clinician if any signs of unexplained wounds appear on fingers or toes; further clinical evaluation may be appropriate.

• Potential risk of serotonin syndrome with concomitant use of lisdexamfetamine and other serotonergic agents (e.g., buspirone, fentanyl, lithium, selective serotonin-reuptake inhibitors [SSRIs], selective serotonin- and norepinephrine-reuptake inhibitors [SNRIs], tramadol, tricyclic antidepressants, 5-hydroxytryptamine type 1 [5-HT₁] receptor agonists [triptans], tryptophan, and St. John’s wort [Hypericum perforatum]) or drugs that impair metabolism of serotonin (e.g., MAO inhibitors), both those used to treat psychiatric disorders and others, such as the anti-infective agent linezolid. Advise patients to immediately contact their clinician if signs and/or symptoms of serotonin syndrome develop.

• Inform patients that motor and verbal tics and worsening of Tourette’s syndrome can occur during stimulant therapy. Advise patients to notify their clinician if there is an emergence of new or worsening tics or Tourette’s syndrome.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses (e.g., hypertension, cardiovascular disease, psychiatric disorders).

• Advise patients to inform their clinician if they are or plan to become pregnant. Inform patients that there is a pregnancy registry available that monitors outcomes in patients exposed to lisdexamfetamine during pregnancy.

• Advise patients to avoid breast-feeding during therapy.

• Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.

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