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. |
| Molecular Weight | 269.33 |
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 | Methylphenidate is generally not recommended during first trimester due to a lack of adequate safety data, though some studies show no major teratogenic risk. Use only if benefit clearly outweighs risk. |
| 2nd trimester | Limited data; potential for increased risk of low birth weight and preterm birth. Use only if clearly needed. |
| 3rd trimester | Avoid near term due to risk of neonatal withdrawal (e.g., irritability, feeding problems) and possible increased risk of preeclampsia. |
Clinical note
Comprehensive clinical and safety monograph for JORNAY PM (JORNAY PM).
| Placental transfer | Methylphenidate crosses the placenta; fetal exposure is approximately 1-4% of maternal plasma concentration. |
| Breastfeeding | Methylphenidate is excreted into breast milk in small amounts. Infant exposure is estimated at 0.2-0.7% of maternal weight-adjusted dose. Monitor infant for agitation, insomnia, and poor weight gain. Use with caution and only if benefits outweigh risks. |
■ 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 |
Hypersensitivity to methylphenidate or any componentConcomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 daysGlaucomaSevere hypertension or cardiovascular disease (e.g., structural cardiac abnormalities, cardiomyopathy, serious arrhythmias)
| 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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| Lactation Rating | L3 (Moderately Safe) |
| 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). |
| 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. |
| Food/Dietary | Avoid alcohol consumption. High-fat meals may affect absorption; take consistently with or without food. Do not take with grapefruit juice as it may increase methylphenidate levels. |
| Clinical Pearls | JORNAY PM is a methylphenidate product with a delayed-release and extended-release profile designed for evening dosing to improve morning ADHD symptoms. Do not crush or chew capsules; they can be opened and sprinkled on applesauce. Monitor for growth suppression in children and potential for elevation in blood pressure and heart rate. Avoid use in patients with known structural cardiac abnormalities, glaucoma, tics, or Tourette's disorder. May cause abrupt onset of severe allergic reactions, including anaphylaxis; educate patients on signs of angioedema. |
| Patient Advice | Take JORNAY PM once daily in the evening between 7 PM and 9 PM, starting with the lowest effective evening dose. · Swallow capsules whole or open and sprinkle entire contents onto a spoonful of applesauce; consume immediately without chewing. · Avoid alcohol; it can alter drug release and increase side effects. · Do not drive or operate machinery until you know how this medication affects you. · Report any signs of allergic reaction (rash, hives, itching, difficulty breathing, swelling) immediately. · May cause weight loss and growth slowing in children; monitor height and weight regularly. · Avoid caffeine or other stimulants during the daytime as they may add to side effects like nervousness and insomnia. |