Introduction
Jornay PM (methylphenidate hydrochloride) is a novel extended-release formulation of methylphenidate specifically designed with a delayed and extended release profile. This unique formulation is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Unlike traditional methylphenidate formulations, Jornay PM is administered in the evening with effects beginning the following morning and lasting throughout the day.
Mechanism of Action
Jornay PM contains methylphenidate hydrochloride, a central nervous system (CNS) stimulant. The exact mechanism by which methylphenidate produces its therapeutic effects in ADHD is not fully understood, but it is believed to block the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing the release of these monoamines into the extraneuronal space. The delayed and extended release profile is achieved through a proprietary multilayer bead technology that provides an initial delay in release followed by extended drug delivery.
Indications
Jornay PM is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.
Dosage and Administration
- Administer once daily in the evening, approximately 10-12 hours before the desired effect onset time
- Starting dose: 20 mg once daily
- Titration: May increase weekly in increments of 20 mg
- Maximum dose: 100 mg daily
- Administer whole capsules; do not crush, chew, or divide
- May be swallowed whole or opened and sprinkled on applesauce
- Dosage adjustment recommended in patients with renal or hepatic impairment
- Not recommended for patients with severe renal or hepatic impairment
Pharmacokinetics
- Absorption: Delayed release profile with initial release approximately 8 hours after evening administration. Tmax occurs at approximately 14-16 hours post-dose.
- Distribution: Methylphenidate is approximately 15% bound to plasma proteins
- Metabolism: Primarily metabolized by carboxylesterase CES1A1 via de-esterification to ritalinic acid
- Elimination: Half-life approximately 3.5 hours. Excreted primarily in urine (78-97% of dose) as ritalinic acid within 48-96 hours
Contraindications
- Known hypersensitivity to methylphenidate or product components
- Patients with glaucoma
- Patients with motor tics or Tourette's syndrome, or family history of Tourette's syndrome
- During or within 14 days following MAO inhibitor therapy
Warnings and Precautions
- Abuse and Dependence: CNS stimulants have high potential for abuse and dependence
- Serious Cardiovascular Events: Sudden death, stroke, and myocardial infarction have been reported
- Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse
- Psychiatric Adverse Reactions: May exacerbate symptoms of behavior disturbance and thought disorder
- Suppression of Growth: Monitor height and weight in pediatric patients
- Peripheral Vasculopathy: Raynaud's phenomenon has been reported
- Long-Term Suppression of Growth: Monitor growth parameters in pediatric patients
Drug Interactions
- MAO Inhibitors: Risk of hypertensive crisis
- Antihypertensive Drugs: Methylphenidate may decrease effectiveness
- Warfarin: Possible altered anticoagulant response
- Clonidine: Serious adverse events reported with concomitant use (not systematically studied)
- Serotonergic Drugs: Risk of serotonin syndrome
Adverse Effects
Common adverse reactions (≥5% and twice the rate of placebo):- Insomnia (18%)
- Decreased appetite (16%)
- Headache (14%)
- Irritability (7%)
- Weight decreased (7%)
- Nausea (6%)
- Anxiety (6%)
- Dizziness (5%)
- Abuse and dependence
- Psychotic symptoms
- Cardiovascular reactions
- Priapism
- Peripheral vasculopathy
Monitoring Parameters
- Height and weight in pediatric patients (at least every 6 months)
- Blood pressure and heart rate at initiation, following dose changes, and periodically during treatment
- Signs of drug abuse, dependence, and diversion
- Psychiatric symptoms including emergence of new psychotic or manic symptoms
- Peripheral digital changes
Patient Education
- Take medication exactly as prescribed in the evening
- Do not crush, chew, or break capsules
- May be taken whole or sprinkled on applesauce
- Report any chest pain, shortness of breath, or fainting
- Monitor for new or worsening behavioral problems
- Be aware of potential for abuse and dependence
- Report any prolonged or painful erections
- Inform healthcare providers of all medications being taken
- Keep medication in a secure place to prevent misuse
References
1. Jornay PM [package insert]. Grand Prairie, TX: Ironshore Pharmaceuticals Inc; 2020. 2. Childress AC, Wigal S, Brams M, et al. Efficacy and safety of HLD200, a delayed-release and extended-release methylphenidate, in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2020;30(8):474-485. 3. Wigal SB, Childress AC, Brams MN, et al. Efficacy and safety of a novel delayed-release and extended-release methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2020;81(2):19m12935. 4. Food and Drug Administration. Jornay PM approval letter. August 2018. 5. Pliszka S; AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.