Are Concerta (methylphenidate) and amphetamine considered controlled substances?

Are Concerta and Amphetamine Controlled Substances?

Yes, both Concerta (methylphenidate) and amphetamine are federally controlled substances classified as Schedule II by the FDA due to their high potential for abuse and dependence. 1, 2

Regulatory Classification

Methylphenidate (Concerta)

• Methylphenidate is an FDA Schedule II controlled substance with a black box warning stating it should be given cautiously to patients with a history of drug dependence or alcoholism 3
• The Schedule II designation indicates these drugs have medical value but present a high potential for abuse 4
• Methylphenidate and dextroamphetamine are scheduled as controlled drugs because of their rapid onset of action, immediate behavioral effects, and tendency to develop tolerance with continued use, which leads to increased risk for abuse and dependence in vulnerable individuals 3

Amphetamine

• Dextroamphetamine is an FDA Schedule II federally controlled substance with a black box warning stating that it has a high potential for abuse, and prolonged administration may lead to dependence 3
• Amphetamines have been extensively abused, with reports of tolerance, extreme psychological dependence, and severe social disability 2

Abuse and Dependence Potential

Physical Dependence Characteristics

• Methylphenidate may produce physical dependence, manifested by withdrawal signs and symptoms after abrupt discontinuation or significant dose reduction, including dysphoric mood, depression, fatigue, vivid unpleasant dreams, insomnia or hypersomnia, increased appetite, and psychomotor retardation or agitation 1
• Abrupt cessation of amphetamines following prolonged high dosage administration results in extreme fatigue and mental depression, with changes noted on the sleep EEG 2

Misuse Patterns and Risks

• Misuse and abuse of methylphenidate can result in overdose and death, with this risk increased with higher doses and unapproved methods of administration, such as snorting or injection 1
• Misuse often involves higher doses than prescribed or using non-oral routes of administration (e.g., snorting) 5
• Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have been observed with CNS stimulants abuse and/or misuse 1

Clinical Context and Safeguards

Prescribing Considerations

• Both medications stimulate adrenergic receptors directly as agonists and indirectly cause the release of dopamine and norepinephrine from presynaptic terminals 3
• Available data suggest that methylphenidate has pharmacokinetic properties that reduce its abuse potential compared with stimulant drugs of abuse, such as cocaine 3, 6

Formulation-Specific Abuse Deterrence

• Newer extended-release preparations, such as Concerta (OROS-methylphenidate), are less prone to abuse and diversion than immediate-release methylphenidate tablets because the medication is in the form of a paste which cannot be ground up or snorted 3
• Long-acting formulations need only be given once daily by parents and not taken to school, where they could be given away or sold 3

Common Pitfalls to Avoid

• Do not assume that because these medications are prescribed for legitimate medical conditions (ADHD, narcolepsy) they lack abuse potential—the Schedule II classification reflects real risks 3, 1, 2
• Do not overlook screening for personal or family history of substance misuse before prescribing, as these patients are at increased risk 3
• Do not ignore the possibility that parents or other family members may abuse the child's stimulant medications, making it important to ask whether anyone in the house has a problem with substance abuse 3
• Do not send stimulant medications to an adolescent's school if avoidable, to reduce the opportunity for drug diversion and to avoid peer ridicule 3