What FDA‑approved transdermal patches are available for treating ADHD in children aged 6 years and older?

FDA-Approved Transdermal ADHD Patch for Pediatric Patients

The methylphenidate transdermal system (MTS, brand name Daytrana) is the only FDA-approved ADHD patch for children aged 6 years and older, delivering methylphenidate doses of 10–30 mg over a 9-hour wear period with once-daily application. 1, 2

Patch Specifications and Dosing

• The MTS patch is available in four sizes (12.5,18.75,25, and 37.5 cm²) that deliver methylphenidate doses of 10,15,20, and 30 mg respectively over a 9-hour wear time. 1, 2
• The patch should be applied to the hip once daily in the morning and worn for a maximum of 9 hours, with removal typically occurring in the late afternoon or early evening. 2
• Peak plasma concentrations of d-methylphenidate (20–46.5 ng/mL) are reached approximately 8–10 hours after application, with therapeutic effects beginning as early as 2 hours post-application and lasting up to 12 hours with a 9-hour wear time. 1, 2, 3

Clinical Efficacy Evidence

• In randomized, double-blind, placebo-controlled trials, children aged 6–12 years treated with MTS patches showed statistically significant improvements in ADHD symptoms compared to placebo recipients, with benefits observed at the first evaluation point (2 hours post-application) and sustained through 12 hours. 1, 3
• Laboratory classroom assessments demonstrated significant improvements on all efficacy measures including attention, behavior, and academic performance ratings from teachers, parents, and patients. 3
• The MTS provides flexible dosing through variable wear times, allowing parents to remove the patch earlier if shorter symptom coverage is needed (e.g., for weekends or days without homework demands). 2

Safety and Tolerability Profile

• Adverse events with the MTS are similar to those seen with oral methylphenidate formulations (decreased appetite, insomnia, headache), with the addition of application-site skin reactions that are generally mild to moderate in severity. 1, 2
• The incidence of contact allergic dermatitis with MTS is less than 1%, making serious skin reactions uncommon. 2
• The elimination half-life for methylphenidate is 3–4 hours after patch removal, allowing for predictable offset of effects. 2

Clinical Advantages Over Oral Formulations

• The transdermal delivery system eliminates the need for in-school medication administration, reducing embarrassment and improving compliance in school-age children who may be self-conscious about taking pills during the school day. 4
• The patch is particularly useful for children who have difficulty swallowing tablets or capsules, or who dislike the taste or texture of chewable, oral disintegrating, or liquid methylphenidate formulations. 5
• Parents can visually confirm medication administration and adherence by checking whether the patch is in place, addressing a common compliance concern with oral medications. 2

Monitoring Requirements

• Baseline blood pressure and pulse should be obtained before initiating MTS therapy, with regular cardiovascular monitoring during treatment as recommended for all stimulant medications. 6
• Height and weight should be tracked at each visit to monitor for growth suppression, a known effect of chronic stimulant use. 6
• Application sites should be rotated to minimize skin irritation, and parents should inspect the skin for persistent redness, swelling, or other dermal reactions. 2

Emerging Alternative: Dextroamphetamine Transdermal System

• A dextroamphetamine transdermal system (d-ATS) was recently approved by the FDA for ADHD treatment in both pediatric patients and adults, offering an amphetamine-based alternative to the methylphenidate patch. 5
• The d-ATS provides flexibility in wear time to accommodate changing schedules, though dermal discomfort must be considered in addition to typical amphetamine side effects when prescribing. 5
• Efficacy and safety data from laboratory classroom studies in children and adolescents demonstrate therapeutic benefit, though patient and provider experience will determine the frequency of d-ATS use in clinical practice. 5

Clinical Decision Algorithm

For a child aged 6–12 years with ADHD who requires once-daily dosing and has difficulty with oral medications or needs flexible symptom coverage:

1. Start with MTS 10 mg patch (12.5 cm²) applied to the hip each morning, worn for 9 hours. 2, 3
2. Titrate weekly by increasing patch size (15 mg → 20 mg → 30 mg) based on symptom response and tolerability, using parent and teacher rating scales to assess efficacy. 3
3. If skin reactions occur, rotate application sites and consider switching to oral methylphenidate formulations or the d-ATS if amphetamine-based therapy is preferred. 2, 5
4. If inadequate response after optimizing to the 30 mg patch, trial an amphetamine-based stimulant (oral or transdermal) before considering non-stimulant options, as approximately 40% of patients respond to only one stimulant class. 7