BOXED WARNING High potential for abuse, misuse, and addiction; misuse/abuse can cause overdose and death — assess risk before prescribing and monitor throughout treatment.
FDA dosing
Population
Start
Target
Max
Narcolepsy
Adults
10 mg QD
5–60 mg/day in divided doses
60 mg/day
Narcolepsy
≥12 yr
10 mg QD
↑10 mg/day weekly to optimal response
60 mg/day
Narcolepsy
6–12 yr
5 mg QD
↑5 mg/day weekly to optimal response
60 mg/day
ADHD (attention deficit disorder with hyperactivity)
3–5 yr
2.5 mg QD
↑2.5 mg/day weekly to optimal response
Not stated
ADHD (attention deficit disorder with hyperactivity)
≥6 yr
5 mg QD–BID
↑5 mg/day weekly to optimal response
40 mg/day (rarely necessary to exceed)
Titration Increase at weekly intervals.
Renal Undefined
Hepatic Undefined
Instructions
Use the lowest effective dosage; individualize.
Give first dose on awakening; 1 or 2 additional doses at 4–6 hr intervals.
Avoid late-evening doses (causes insomnia).
Reduce dose if bothersome adverse reactions appear (e.g. insomnia, anorexia).
ADHD: interrupt therapy occasionally to determine whether behavioral symptoms recur and continued treatment is needed.
Before treating: assess for cardiac disease (history, family history of sudden death or ventricular arrhythmia, physical exam) and evaluate family history/patient for motor or verbal tics or Tourette's syndrome.
Not recommended in pediatric patients under 3 years of age.
Contraindications
MAOIs (concurrently or within 14 days) due to risk of hypertensive crisis
Pheochromocytoma or history of pheochromocytoma — serious reactions incl. elevated blood pressure and tachyarrhythmia reported
Cautions
Abuse, misuse, and addiction (boxed) - high potential; can lead to substance use disorder, overdose, and death; assess risk before prescribing, reassess and monitor throughout treatment; counsel on secure (preferably locked) storage and disposal
Sudden death reported in patients with structural cardiac abnormalities or other serious cardiac disease at recommended ADHD doses - avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmia, or coronary artery disease
Increases blood pressure (mean ~2-4 mm Hg) and heart rate (mean ~3-6 bpm) - monitor all patients for tachycardia and hypertension
Psychiatric reactions: may exacerbate pre-existing psychosis; may induce manic/mixed episode in bipolar disorder (screen for risk factors first); new psychotic or manic symptoms (~0.1%) at recommended doses in patients without prior history - consider discontinuing
Long-term suppression of growth in pediatric patients - closely monitor weight and height; interrupt treatment if not growing/gaining as expected
May lower the convulsive threshold - discontinue if seizures occur
Peripheral vasculopathy, including Raynaud's phenomenon - observe for digital changes; rare digital ulceration/soft-tissue breakdown; consider rheumatology referral
Serotonin syndrome (potentially life-threatening) with serotonergic drugs (SSRIs, SNRIs, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) or CYP2D6 inhibitors; MAOI use contraindicated - discontinue immediately if it occurs
Onset or exacerbation of motor/verbal tics and worsening of Tourette's syndrome - assess family history and evaluate before initiating; monitor regularly, discontinue if clinically appropriate
Adverse reactions
Palpitations, tachycardia, elevated blood pressure; isolated reports of cardiomyopathy with chronic use