What is the recommended starting dose of Concerta (methylphenidate) for an adult?

Starting Dose of Concerta for Adults

For adults initiating Concerta (OROS methylphenidate), the FDA-approved starting dose is 18 mg once daily in the morning, with titration in 18 mg increments at weekly intervals as needed, up to a maximum of 72 mg daily. 1

FDA-Approved Adult Dosing

• Initial dose: 18 mg once daily in the morning 1
• Administration timing: Preferably 30-45 minutes before breakfast, though food does not significantly affect absorption 1, 2
• Titration schedule: Increase by 18 mg increments weekly based on response and tolerability 1
• Maximum daily dose: 72 mg (though the immediate-release methylphenidate label specifies 60 mg as the maximum) 1
• Average therapeutic dose: 20-30 mg daily of methylphenidate equivalents 1

Key Dosing Considerations

Dose Equivalency

• Concerta 18 mg once daily is equivalent to methylphenidate immediate-release 5 mg three times daily 3
• The OROS delivery system provides an ascending plasma concentration profile over 10-12 hours, designed to overcome acute tolerance (tachyphylaxis) 4
• This ascending pattern maintains efficacy throughout the day without the need for multiple doses 4

Timing and Sleep

• For patients with insomnia, administer the last (or only) dose before 6 PM to minimize sleep disturbance 1
• The duration of action is approximately 12 hours with the OROS formulation 5

Pretreatment Screening Requirements

Before prescribing Concerta, the FDA mandates assessment for: 1

• Cardiac disease: Obtain careful personal and family history of sudden death, ventricular arrhythmia, structural cardiac abnormalities, cardiomyopathy, or serious arrhythmias
• Tics and Tourette's syndrome: Evaluate family history and clinically assess for motor or verbal tics
• Risk factors for abuse: Screen each patient's risk for substance use disorder, as methylphenidate has high abuse potential

Important Safety Warnings

Contraindications

• Avoid in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease 1
• Contraindicated with concurrent MAOI use or within 14 days of MAOI discontinuation 1

Monitoring Requirements

• Blood pressure and heart rate: Monitor regularly, as CNS stimulants increase BP by 2-4 mmHg and heart rate by 3-6 bpm on average 1
• Psychiatric symptoms: Screen for risk factors for mania before initiating; monitor for emergence of psychotic or manic symptoms 1
• Abuse and misuse: Reassess risk throughout treatment and monitor for signs of diversion or substance use disorder 1

Advantages of OROS Formulation

• Food-independent absorption: Unlike amphetamine extended-release formulations, Concerta provides consistent early drug exposure regardless of high-fat breakfast consumption 2
• Once-daily dosing: Eliminates need for mid-day administration, improving privacy, reducing stigma, and enhancing adherence 5
• Predictable pharmacokinetics: Rapid rise in plasma concentration within 1-2 hours, followed by gradually increasing levels that peak at 7-9 hours post-dose 4

Titration Strategy

• Start at 18 mg once daily in treatment-naïve adults 1
• Increase by 18 mg weekly if response is inadequate and medication is well-tolerated 1
• Assess response after one month: If no improvement after appropriate dosage adjustment over one month, discontinue treatment 1
• Typical therapeutic range: Most adults respond to 36-54 mg daily, though some may require up to 72 mg 1

Common Pitfalls to Avoid

• Do not exceed 72 mg daily without specialist consultation 1
• Do not administer late in the day if sleep disturbance occurs; ensure last dose is before 6 PM 1
• Do not use in patients with serious cardiac disease without cardiology clearance 1
• Do not assume plasma levels correlate with response—clinical assessment using rating scales is more predictive than drug levels 3