Vyvanse

(lisdexamfetamine dimesylate)
Vyvanse (lisdexamfetamine dimesylate); CII
Full Prescribing Information
DailyMed Drug Information
Summary
Vyvanse is a long-acting amphetamine prodrug approved for ADHD from age 6 and for moderate to severe binge eating disorder in adults only. It is pharmacologically inert until red blood cells hydrolyse it to dextroamphetamine, so its onset is governed by that conversion rather than by a coating, a bead or a matrix. That single property is its differentiator: there is no release mechanism to defeat by crushing, chewing or dissolving, and capsule and chewable tablet interchange milligram for milligram. Schedule II; brand and generic.
Forms & Strengths
Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg
Chewable tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Oral solution (Arynta, a separate NDA product): 10 mg/mL
Dosing
Age:
ADHD: ≥ 6 y/o; not recommended below 6 years
Binge eating disorder: ≥ 18 y/o only; not established under 18
Onset: 1.5-2 hours
Duration: 13-14 hours
Release Profile: None. Inactive prodrug hydrolysed by red blood cells; Tmax about 3.5 h from the capsule, 4.4 h from the chewable
Initial Dose:
ADHD, ≥ 6 y/o and adults: 30 mg once daily in the morning
BED, adults: 30 mg once daily in the morning
Titration:
ADHD: 10 mg or 20 mg at approximately weekly intervals
BED: 20 mg at approximately weekly intervals, to a target of 50 to 70 mg/day
Max Dose:
ADHD and BED: 70 mg/day
Severe renal impairment (GFR 15 to < 30): 50 mg/day
End stage renal disease (GFR < 15): 30 mg/day
Considerations: Give in the morning; avoid afternoon doses. Capsule and chewable substitute milligram for milligram, but there is no 70 mg chewable.
Pharmacology
Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
Prodrug: Dextroamphetamine bound to L-lysine, inactive as swallowed; the parent does not bind DAT or NET
Delivery / Release: None. Hydrolysis in blood means crushing, chewing or dissolving does not accelerate it
Metabolism: Not metabolised by CYP450. Prodrug half-life under 1 hour; dextroamphetamine 8.6-9.5 h in children 6-12, 10-11.3 h in adults
Pharmacogenomics: Activation is CYP-independent; downstream clearance still involves CYP2D6. No genotype-directed dosing
Class Positioning: No bead, coating or pH trigger, so gut pH and PPIs matter far less than for Adderall XR or Mydayis. Shorter than Mydayis but available from age 6
Indications
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o and adults
Moderate to severe binge eating disorder (ICD-10: F50.81): adults ≥ 18 y/o only
Limitation of Use: not indicated for weight loss or obesity
Off-Label Uses
Binge eating disorder in adolescents (ICD-10: F50.81): insufficient. Document and consent as off-label if used.
Narcolepsy (ICD-10: G47.419): off-label at every age; insufficient. Use an approved product: Adderall, Zenzedi, Dexedrine Spansule.
Depression augmentation (ICD-10: F33.x): studied as adjunct in adult MDD, indication not granted; insufficient.
ADHD under 6 years (ICD-10: F90.x): studied and rejected; weight loss and insomnia at exposures 44% above the 6-11 band. AAP names behavioral intervention first-line (AAP 2019).
Cognitive enhancement or weight loss: not indications; weight loss is explicitly excluded by the label (AHRQ 2024).
Contraindications & Warnings
Boxed Warning: Abuse, misuse, and addiction; misuse can cause overdose and death. Assess abuse risk before prescribing and monitor throughout. The prodrug design does not exempt this product.
Contraindicated:
Known hypersensitivity to amphetamine products or any ingredient in Vyvanse
MAOI use, current or within 14 days
Use with caution (label Warnings, not contraindications):
Structural cardiac abnormality or serious arrhythmia; the label says avoid
Pre-existing hypertension; blood pressure and heart rate rise
Psychosis or bipolar disorder
Peripheral vasculopathy including Raynaud phenomenon
Tics or Tourette syndrome, personal or family
Substance use disorder, patient or household
Renal impairment; maximum 50 mg severe, 30 mg ESRD
Restrictive eating features, where appetite suppression is reinforcing
Screen before starting:
Cardiac and family history of sudden death; ECG only if positive
Tics, Tourette syndrome and mania risk factors
Abuse and diversion risk
Baseline height, weight, blood pressure and heart rate
Eating attitudes and restrictive or purging behaviour
Drug Interactions
MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, IV methylene blue): hypertensive crisis; do not give within 14 days.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone): serotonin syndrome; counsel on symptoms and stop both if it occurs.
CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion, quinidine): raise dextroamphetamine exposure, though not prodrug activation; start lower.
Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels by reducing renal elimination; adjust the dose.
Acidifying agents (high-dose ascorbic acid, ammonium chloride): lower levels; adjust on response. Orange juice as a dispersal vehicle does not change exposure.
Administration
Once daily in the morning, with or without food; afternoon doses cost sleep.
Swallow whole, or empty the entire contents into yogurt, water or orange juice, mix and drink immediately. Do not store.
A film left in the glass is inactive ingredient, not lost drug.
Chewable tablets must be chewed thoroughly.
Capsule and chewable substitute milligram for milligram with no re-titration; 70 mg exists only as a capsule.
Do not take less than one capsule or tablet daily; do not divide a dose.
A high-fat meal delays Tmax by about an hour without changing absorption.
If a dose is missed, skip it; do not double up.
Store securely, preferably locked; the prodrug limits snorting and injection but does not make diversion safe.
Side Effects
Common, 6 to 12: decreased appetite 39%, insomnia 22%, upper abdominal pain 12%, irritability 10%, vomiting 9%, decreased weight 9%, dizziness 5%, tic 2%
Common, 13 to 17: decreased appetite 34%, insomnia 13%, decreased weight 9%, dry mouth 4%, palpitations 2%, tremor 2%
Serious:
Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
Psychosis, mania and new aggression. Consider discontinuing.
Serotonin syndrome, from coadministration or overdose. Stop both drugs and treat supportively.
Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
Growth suppression. Interrupt if height or weight gain falls behind.
New or worsening motor and verbal tics. Discontinue if clinically appropriate.
Monitoring & Labs
Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if the child crosses two major percentile lines.
Appetite and Sleep: at every visit and dose change; ask about sleep-onset latency and midday intake.
Psychiatric and tics: psychosis, mania, aggression, affect lability and new tics at every visit.
Peripheral vasculopathy: inspect fingers and toes at every visit.
Abuse and Diversion: adherence, pill counts and PDMP check at every refill.
Renal function: at baseline where impairment is suspected, and annually.
Eating behaviour where BED or restrictive features exist: at every visit.
Laboratory: none routinely.
Discontinuation & Taper
May be stopped abruptly at therapeutic doses; no taper is required.
Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
Rebound irritability and hunger land in the evening, not after school.
In BED, the label instructs discontinuing if binge eating does not improve; apply that stopping rule.
Interrupt treatment where growth or weight gain falls behind.
Drug holidays work better here; restarting needs no re-titration.
Pregnancy & Lactation
Pregnancy: No identified risk of major birth defects or miscarriage. Premature delivery and low birth weight reported. Monitor exposed newborns for withdrawal.
Lactation: Label says breastfeeding is not recommended. Relative infant dose 2 to 13.8%; no reported infant adverse effects.
Lactation, drug-specific: Two small series found colic, restlessness and delayed birthweight regain in a minority, with normal follow-up. (LactMed 2026)
Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2026)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.
Counseling Points
Counsel the family on:
The capsule does nothing until the body converts it, so effect starts around 90 minutes.
Emptying it into water, yogurt or juice is a complete option for a child who cannot swallow capsules.
Capsule and chewable interchange milligram for milligram, except that no 70 mg chewable exists.
The prodrug makes snorting or injection harder; it does not make sharing safe.
Appetite loss 39% at ages 6 to 12, the highest here. Move the largest meal to breakfast and evening.
Where a family has heard Vyvanse "treats binge eating": adults only, never for weight loss.
Locked storage; sharing or selling a Schedule II medication is a felony.
Bring a teacher rating scale to the next visit.
Advise them to call for:
Chest pain on exertion, fainting, or a racing heart that does not settle.
New hallucinations, or new suspicious or fearful thinking.
Numbness, coldness or colour change in the fingers or toes.
A new or markedly worse tic, motor or verbal.
Weight loss, or a child eating nothing between breakfast and dinner.
New meal skipping, hiding food, or a stated wish to lose weight.
Agitation, shivering, sweating or confusion after an antidepressant change.
References
DailyMed. VYVANSE (lisdexamfetamine dimesylate) capsules and chewable tablets prescribing information. Takeda Pharmaceuticals America. Revised 4/2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=704e4378-ca83-445c-8b45-3cfa51c1ecad
LactMed. Lisdexamfetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2026. https://www.ncbi.nlm.nih.gov/books/NBK501741/
openFDA. NDC Directory, generic_name "lisdexamfetamine". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis
Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
DailyMed. Arynta (lisdexamfetamine dimesylate) oral solution prescribing information. Azurity Pharmaceuticals, Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71cdfc97-96af-4378-a44a-6d5d77e7d6b7