Last reviewed · How we verify
OROS methylphenidate
OROS methylphenidate is a central nervous system stimulant that increases dopamine and norepinephrine activity in the brain to improve attention and reduce hyperactivity.
OROS methylphenidate is a central nervous system stimulant that increases dopamine and norepinephrine activity in the brain to improve attention and reduce hyperactivity. Used for Attention deficit hyperactivity disorder (ADHD) in children and adults.
At a glance
| Generic name | OROS methylphenidate |
|---|---|
| Also known as | concerta, Concerta |
| Sponsor | University of Utah |
| Drug class | Sympathomimetic amine; central nervous system stimulant |
| Target | Dopamine transporter (DAT); norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | FDA-approved |
Mechanism of action
Methylphenidate blocks the reuptake of dopamine and norepinephrine at the presynaptic neuron, increasing their concentration in the synaptic cleft. The OROS (osmotic release oral system) formulation provides extended-release delivery over 12 hours, maintaining therapeutic levels throughout the day. This mechanism enhances focus, attention, and impulse control in patients with attention deficit hyperactivity disorder.
Approved indications
- Attention deficit hyperactivity disorder (ADHD) in children and adults
Common side effects
- Insomnia
- Decreased appetite
- Headache
- Nervousness/anxiety
- Abdominal pain
- Tachycardia
- Elevated blood pressure
Key clinical trials
- Benefits of ADHD Treatment in Detained People (PHASE3)
- The Effects of ADHD Medication (TEAM) Study (PHASE4)
- Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) (PHASE4)
- The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original (NA)
- Pharmacogenetic Studies on Attention Deficit Hyperactivity Disorder
- Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 (PHASE3)
- Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder (PHASE4)
- Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |