Standard Dosing of Mydayis for ADHD
Mydayis dosing differs by age group: adults (18+ years) should start at 12.5 mg once daily in the morning and may titrate to 12.5 mg, 25 mg, 37.5 mg, or 50 mg daily based on response; adolescents (13–17 years) should use 12.5 mg or 25 mg once daily, with the maximum dose being 25 mg. 1
Adult Dosing (18–55 years)
- Starting dose: 12.5 mg once daily in the morning 1
- Available doses: 12.5 mg, 25 mg, 37.5 mg, and 50 mg once daily 1
- Maximum recommended dose: 50 mg once daily 1
- Titration approach: Doses were evaluated using forced-dose titration in clinical trials, with weekly increases from 12.5 mg to target doses of 37.5 mg by Week 3 1
- Important note: Doses up to 75 mg daily (1.5 times the maximum recommended dose) were studied but demonstrated no additional clinical benefit beyond 50 mg and are not recommended 1, 2
Adolescent Dosing (13–17 years)
- Starting dose: 12.5 mg once daily 1
- Available doses: 12.5 mg or 25 mg once daily 1
- Maximum recommended dose: 25 mg once daily 1
- Clinical trial data: A 4-week randomized controlled trial evaluated dose-optimized Mydayis (12.5–25 mg) in adolescents aged 13–17 years, demonstrating significant efficacy over placebo 1, 3
Children (6–12 years)
- Not recommended: The 6.25 mg dose (one-half the lowest approved dose for adolescents and adults) was studied in children aged 6–12 years but failed to demonstrate superiority over placebo, indicating this dose was subtherapeutic in this age group 4
- Current FDA approval: Mydayis is not approved for children under 13 years of age 1
Key Administration Details
- Timing: Administer once daily in the morning upon awakening 1
- Duration of effect: Clinical trials demonstrated efficacy from 2 hours post-dose through 16 hours post-dose in adults 1
- Pharmacokinetic considerations: Adolescents (13–17 years) show approximately 21–31% higher exposure (Cmax and AUC) for both d- and l-amphetamine compared to adults receiving the same dose, which supports the lower maximum dose of 25 mg in this age group 1
Clinical Efficacy by Dose
- 12.5 mg and 37.5 mg: Both doses demonstrated statistically significant improvement in ADHD Rating Scale total scores compared to placebo at Week 4 in adults 1
- 25 mg and 50 mg: Both doses showed statistically significant treatment effects beginning at 2–4 hours post-dose and continuing through 16 hours post-dose on objective attention measures (PERMP) 1
- No dose-response relationship: Clinical trials found no significant differences in efficacy between different Mydayis dosages within the approved range, suggesting individual response variability 2
Safety Monitoring
- Most common adverse reactions in adults: Insomnia (31%), decreased appetite (30%), dry mouth (23%), weight decrease (9%), heart rate increase (9%), and anxiety (7%) 1
- Most common adverse reactions in adolescents: Decreased appetite, nausea, insomnia, upper abdominal pain, irritability, and weight decrease 1
- Discontinuation rates: 9% of adults and 5% of adolescents discontinued due to adverse reactions in controlled trials 1