JORNAY PM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for JORNAY PM (JORNAY PM).
Methylphenidate is a central nervous system (CNS) stimulant. The mode of action in attention deficit hyperactivity disorder (ADHD) is not fully understood, but methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron, increasing the levels of these neurotransmitters in the extraneuronal space.
| Metabolism | Methylphenidate is metabolized primarily by de-esterification via carboxylesterase 1 (CES1) to ritalinic acid, which has little to no pharmacological activity. Minor metabolism via CYP2D6 may contribute to the formation of a hydroxy-methylphenidate metabolite. |
| Excretion | Methylphenidate and its metabolites are primarily excreted in urine (approximately 90%) as metabolites (mainly ritalinic acid) with about 2% unchanged parent drug. Fecal excretion accounts for <1%. |
| Half-life | The terminal elimination half-life of methylphenidate following JORNAY PM administration is approximately 4-5 hours. This relatively short half-life necessitates the delayed-release/extended-release formulation to provide a prolonged duration of effect. |
| Protein binding | Methylphenidate is approximately 15% bound to plasma proteins, with negligible binding to albumin or other specific proteins. |
| Volume of Distribution | The volume of distribution (Vd) of methylphenidate is approximately 2.65 L/kg, indicating extensive tissue distribution beyond total body water. |
| Bioavailability | Oral bioavailability of methylphenidate from JORNAY PM is about 30% (range 11-52%) due to extensive first-pass metabolism. The delayed-release formulation ensures a controlled drug release pattern. |
| Onset of Action | Onset of action occurs approximately 10 hours post-dose (e.g., dose at 8 PM, effect starts at 6 AM the next morning), due to the delayed-release design. |
| Duration of Action | Duration of action is approximately 12 hours after the onset (from about 10 to 22 hours post-dose), providing coverage throughout the school day and into early evening. |
Initial: 20 mg orally once daily at bedtime; increase by 20 mg weekly as needed; max 100 mg/day.
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Renal impairment | No specific adjustment; contraindicated in GFR <30 mL/min (severe renal impairment) due to risk of drug accumulation. |
| Liver impairment | Child-Pugh A: usual dose. Child-Pugh B: reduce dose by 50%. Child-Pugh C: not recommended. |
| Pediatric use | Age 6-17 years: 20 mg initially at bedtime; increase weekly by 20 mg; max 100 mg/day. |
| Geriatric use | Start at 20 mg daily; caution due to increased sensitivity and higher risk of insomnia, weight loss, or cardiovascular effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for JORNAY PM (JORNAY PM).
| Breastfeeding | Excreted in human milk. M/P ratio not established. Caution: monitor infant for agitation, insomnia, anorexia, and weight loss. Decision to breastfeed should consider maternal need and potential infant risks. |
| Teratogenic Risk | Pregnancy Category C. Insufficient human data; animal studies show increased fetal resorptions and reduced pup survival at high doses. First trimester: potential risk based on animal data; second/third trimester: possible increased risk of preterm birth, low birth weight, and neonatal withdrawal syndrome (irritability, feeding difficulties). |
■ FDA Black Box Warning
JORNAY PM has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse may cause sudden death or serious cardiovascular adverse events.
| Serious Effects |
["Known hypersensitivity to methylphenidate or other components of JORNAY PM.","Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or within 14 days following discontinuation of an MAOI, because of the risk of hypertensive crisis.","Glaucoma.","Motor tics or a family history or diagnosis of Tourette's syndrome.","Severe anxiety, tension, or agitation."]
| Precautions | ["Abuse, Misuse, and Addiction: CNS stimulants have a high potential for abuse and misuse. Assess each patient’s risk for abuse and misuse prior to prescribing, and monitor for signs of abuse and misuse during therapy.","Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac disease.","Increased Blood Pressure and Heart Rate: CNS stimulants can increase blood pressure and heart rate. Monitor all patients for tachycardia and hypertension.","Psychiatric Adverse Reactions: May cause psychotic or manic symptoms, particularly in patients with a prior history. Aggression and hostility may occur. Monitor for emergence of new or worsening psychiatric symptoms.","Priapism: Prolonged and painful erections, sometimes requiring surgical intervention, have been reported.","Peripheral Vasculopathy: Including Raynaud’s phenomenon. Monitor for digital changes such as numbness, pain, skin color change, or sensitivity to temperature.","Long-Term Suppression of Growth: Pediatric patients should have their height and weight monitored regularly.","Potential for Overdose due to Medication Errors: JORNAY PM is designed to be administered in the evening. To avoid medication errors, patients and caregivers should be advised that JORNAY PM should be taken in the evening."] |
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| Fetal Monitoring |
| Monitor maternal blood pressure, heart rate, and signs of toxicity (tachycardia, agitation). Fetal monitoring: growth ultrasound in third trimester; assess for neonatal withdrawal if used near term. |
| Fertility Effects | No human fertility studies. Animal studies show no impairment. Theoretical risk due to dopamine agonist effects, but not established in humans. |