What is the controlled substance schedule classification of methylphenidate for a pediatric patient with Attention Deficit Hyperactivity Disorder (ADHD)?

Methylphenidate Schedule Classification

Methylphenidate is a Schedule II (CII) controlled substance under the Controlled Substances Act, indicating it has a high potential for abuse and misuse that can lead to substance use disorder and addiction. 1

Regulatory Classification

• The FDA classifies methylphenidate as a Schedule II controlled substance, the same category as other potent stimulants with significant abuse potential but accepted medical use 1
• This classification applies regardless of patient age or indication (ADHD or narcolepsy), meaning methylphenidate carries Schedule II status whether prescribed to a 5-year-old child or an adult 1

Clinical Implications of Schedule II Status

• The Schedule II designation requires specific prescribing practices: no refills are permitted, prescriptions must be written (or transmitted electronically with proper security), and prescribers must maintain strict documentation 1
• Before prescribing methylphenidate, clinicians must assess each patient's risk for abuse, misuse, and addiction, and educate patients and families about proper storage and disposal 1
• Throughout treatment, clinicians must reassess risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction 1

Evidence Supporting High Abuse Potential

• Methylphenidate functions pharmacologically similar to D-amphetamine and cocaine in 80% of behavioral pharmacology studies, producing reinforcing effects and subjective effects suggestive of abuse potential 2
• The drug overlaps with amphetamine, methamphetamine, and cocaine in subjective, reinforcing, and discriminative stimulus effects, with intranasal abuse producing effects similar to cocaine in both onset and type 3, 4
• The FDA published a docket in September 2019 specifically requesting development of abuse-deterrent formulations for CNS stimulants, emphasizing methylphenidate abuse as a public health concern 3

Special Considerations for Adolescents

• Diversion of ADHD medication (use for purposes other than intended medical use) is a particular concern among adolescents, requiring monitoring of symptoms and prescription-refill requests for signs of misuse or diversion 5
• For adolescents at higher risk, consider formulations with lower abuse potential such as lisdexamfetamine (prodrug requiring metabolism), dermal methylphenidate (Daytrana), or OROS methylphenidate (Concerta), which make extraction more difficult 5
• Screen all adolescents for substance abuse symptoms before initiating methylphenidate treatment 5

Misuse and Overdose Risk

• Misuse and abuse of CNS stimulants, including methylphenidate, can result in overdose and death 1
• The Schedule II classification reflects this serious risk profile and mandates heightened prescriber vigilance and patient education 1