What is the recommended dose of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) for patients with Attention Deficit Hyperactivity Disorder (ADHD)?

Azstarys Dosing for ADHD

For children aged 6-12 years, start Azstarys at 39.2 mg/7.8 mg once daily in the morning, with dose adjustments after one week to either 52.3 mg/10.4 mg (maximum) or 26.1 mg/5.2 mg based on response; for adolescents 13-17 years and adults, start at 39.2 mg/7.8 mg once daily and increase to 52.3 mg/10.4 mg after one week based on response and tolerability. 1

Pediatric Dosing (Ages 6-12 Years)

Starting dose: 39.2 mg/7.8 mg (serdexmethylphenidate/dexmethylphenidate) orally once daily in the morning 1

Titration schedule:

• After one week, adjust dose based on clinical response 1
• May increase to 52.3 mg/10.4 mg once daily (maximum dose) 1
• May decrease to 26.1 mg/5.2 mg once daily if needed 1

Maximum recommended dose: 52.3 mg/10.4 mg once daily 1

Adolescent (13-17 Years) and Adult Dosing

Starting dose: 39.2 mg/7.8 mg orally once daily in the morning 1

Titration schedule:

• Increase after one week to 52.3 mg/10.4 mg once daily depending on response and tolerability 1
• This represents the standard maintenance dose for this age group 1

Administration Guidelines

Timing: Administer once daily in the morning to minimize sleep disturbances 1

Food considerations: May be taken with or without food 1

Administration options:

• Swallow capsules whole, OR 1
• Open capsules and sprinkle contents onto applesauce, OR 1
• Open capsules and add contents to water 1

Critical Dosing Precautions

Do not substitute Azstarys for other methylphenidate products on a milligram-per-milligram basis to avoid substitution errors and overdosage 1. Azstarys contains a prodrug formulation (serdexmethylphenidate) combined with immediate-release dexmethylphenidate, making direct dose conversions inappropriate 1.

Efficacy Timeline and Monitoring

Onset and duration of effect:

• Efficacy demonstrated from 0.5 to 13 hours post-dose in laboratory classroom studies 2
• Significant treatment effects observed from 1 to 10 hours after administration 2
• This extended duration allows for once-daily dosing without midday administration 2

Monitoring during titration:

• Assess both therapeutic response and adverse effects at each dose adjustment 3
• Use standardized ADHD rating scales (such as ADHD-RS-5 or CADS) from teachers and parents for children 2, 4
• Schedule follow-up appointments at least monthly until symptoms stabilize 3
• Monitor vital signs including blood pressure and pulse at each visit 1
• Assess height and weight at appropriate intervals in pediatric patients 1

Common Adverse Effects Requiring Monitoring

The most frequently reported treatment-emergent adverse events in clinical trials were:

• Decreased appetite (18.5%) 4
• Insomnia 2
• Upper respiratory tract infection (9.7%) 4
• Nasopharyngitis (8.0%) 4
• Decreased weight (7.6%) 4
• Irritability (6.7%) 4

These adverse effects were generally mild to moderate in severity and consistent with other methylphenidate products 2, 4.

Pre-Treatment Assessment Requirements

Before initiating Azstarys, conduct the following evaluations:

Cardiovascular screening:

• Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease 1
• Obtain baseline blood pressure and pulse 1

Psychiatric screening:

• Screen for risk factors for developing manic episodes 1
• Assess family history and clinically evaluate for tics or Tourette's syndrome 1

Substance use assessment:

• Assess each patient's risk for abuse, misuse, and addiction before prescribing 1
• Azstarys is a Schedule II controlled substance with high potential for abuse 1

Ophthalmologic considerations:

• Patients at risk for acute angle closure glaucoma (e.g., those with significant hyperopia) should be evaluated by an ophthalmologist 1
• Use caution in patients with open-angle glaucoma or abnormally increased intraocular pressure 1

When to Consider Alternative Treatments

If adequate symptom control is not achieved at the maximum dose of 52.3 mg/10.4 mg, or if intolerable side effects occur, consider:

• Switching to an alternative stimulant formulation (different methylphenidate product or amphetamine-based medication) 5, 3
• Adding or switching to non-stimulant medications such as atomoxetine, guanfacine, or clonidine 5

The general treatment algorithm for ADHD recommends stimulants as first-line therapy, with non-stimulants reserved as second-line options 5. If the first stimulant trial fails, switching to an alternative stimulant formulation is recommended before moving to non-stimulants 5.

Special Population Considerations

Older adolescents and adults: More conservative titration may be appropriate, particularly in treatment-naive patients or those with cardiovascular risk factors 3

Patients with comorbidities: The presence of comorbid conditions (anxiety, depression, tic disorders, substance use disorders) may influence medication selection and require consideration of non-stimulant alternatives 5