Jornay PM

(methylphenidate hydrochloride)
Jornay PM (methylphenidate hydrochloride); CII
Full Prescribing Information
DailyMed Drug Information
Summary
Jornay PM is a long-acting methylphenidate CNS stimulant in a capsule taken in the evening, not the morning, and approved for ADHD from age 6 with no upper age limit. A delayed-release outer coat holds absorption overnight and an inner extended-release coat meters the drug across the following day. It is the only methylphenidate that treats the before-school hour, which is why it is chosen over a morning agent. Schedule II; brand only.
Forms & Strengths
Delayed-release and extended-release capsules: 20 mg, 40 mg, 60 mg, 80 mg, 100 mg
Dosing
Age: 6 y/o and older
Onset: delayed until the following morning (~10 hours after an evening dose)
Duration: through the day after dosing
Release Profile: delayed-release outer coat holds absorption overnight; an extended-release inner coat meters release next day
Initial Dose: 20 mg once daily in the evening, started at 8:00 p.m.
Titration: 20 mg every 7 days
Max Dose: 100 mg/day
Considerations: Dose in the evening only, never in the morning. Start at 8:00 p.m., shift within 6:30 to 9:30 p.m. to tune next-morning onset, then hold that time.
Pharmacology
Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: Two functional coats over a drug-coated core; a single peak at median Tmax 14 hours. Dose-proportional from 20 mg to 100 mg.
Metabolism: De-esterified to ritalinic acid, little activity. No CYP pathway. Apparent half-life ~5.9 hours; 90% urinary.
Bioavailability: 73.9% of the same daily dose of immediate-release methylphenidate given TID.
Pediatric exposure: children reach roughly twice adult Cmax and AUC. Titrate from 20 mg regardless of prior therapy.
Class Positioning: The only methylphenidate engineered to reach onset before the patient wakes. Every other long-acting product, Concerta included, leaves the pre-school hour untreated.
Indications
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older
Off-Label Uses
Narcolepsy (ICD-10: G47.411, G47.419): on-label for IR methylphenidate (Ritalin), not here, and a delayed onset suits it poorly; limited data.
Where the evidence does not support use.
ADHD under 6 y/o (ICD-10: F90.x): the label records evidence against, with higher exposure and more adverse reactions including weight loss; insufficient. (AHRQ 2024)
Evening dosing as a sedative: the reverse of what happens. Any insomnia ran 33% versus 9% on placebo; insufficient.
Contraindications & Warnings
Boxed Warning: Abuse, misuse, and addiction. High potential for abuse and misuse, leading to substance use disorder, overdose and death. Assess risk before prescribing and monitor throughout.
Contraindicated:
Hypersensitivity to methylphenidate or any component; angioedema and anaphylaxis reported.
Concomitant MAOI, or within 14 days of stopping one; hypertensive crisis.
Use with caution:
Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; the label says avoid, because of sudden death reports.
Pre-existing hypertension; expect a rise of 2 to 4 mmHg and 3 to 6 bpm. Diastolic rise was reported in 7% of treated children.
Psychotic or bipolar disorder; exacerbation and treatment-emergent mania.
Tics or Tourette's syndrome, personal or family.
Significant hyperopia, open-angle glaucoma, or raised intraocular pressure.
Substance use disorder in the patient or household.
Screen before starting:
Cardiac history, family history of sudden death or arrhythmia, and exam.
Personal and family history of tics or Tourette's syndrome.
Risk factors for mania: past depression, family history of suicide or bipolar disorder.
Baseline sleep pattern. This drug is taken at bedtime and causes insomnia.
Abuse and diversion risk; baseline height, weight, blood pressure and heart rate.
Drug Interactions
MAOIs: hypertensive crisis, with reported death, stroke and MI. Do not co-prescribe, and allow 14 days after stopping.
Antihypertensives: effectiveness may fall. Recheck blood pressure and adjust their dose.
Halogenated anesthetics: sudden intraoperative pressure and rate rise. Hold the capsule the night before surgery.
Risperidone: a dose change either way may raise EPS risk. Monitor for EPS across any change.
Serotonergic agents: serotonin syndrome is postmarketing only here; counsel on symptoms rather than avoid.
Alcohol: ~97% released within 2 hours at 40% alcohol in vitro, during the hours the capsule sits in the stomach. Counsel adolescents explicitly.
Administration
Evening only. Initiate at 8:00 p.m.
Adjust between 6:30 p.m. and 9:30 p.m.; earlier dosing moves onset earlier. Hold the time once optimal.
Take consistently either with food or without food.
Swallow whole, or sprinkle the entire contents onto applesauce and eat immediately without chewing. Never divide a capsule.
Missed dose: take it the same evening; if remembered next morning, skip it.
Switching from another methylphenidate: stop the other product and re-titrate from 20 mg. Never substitute mg-per-mg.
Store securely, preferably locked; dispose through a take-back program.
Side Effects
Common (Study 2, versus placebo): any insomnia 33% vs 9% (initial 14%, middle 11%, terminal 11%), decreased appetite 19% vs 4%, headache 10% vs 5%, vomiting 9% vs 0%, nausea 6% vs 0%, affect lability 6% vs 1%.
Serious:
Sudden death with structural cardiac disease; avoid the drug in that group.
New psychosis or mania, ~0.1% pooled, including with no psychiatric history; consider discontinuing.
Priapism, which may require surgery; also during drug holidays. Seek immediate care.
Peripheral vasculopathy including Raynaud's, with digital ulceration; reduce dose or stop.
Growth suppression: ~2 cm and 2.7 kg less over 3 years. Interrupt if growth stalls.
Acute angle closure glaucoma and raised intraocular pressure.
New or worsening tics; discontinue if clinically appropriate.
Angioedema and anaphylaxis; postmarketing hepatic injury, seizures, rhabdomyolysis, pancytopenia.
Monitoring & Labs
Sleep, in three parts: at every visit and dose change, ask separately about falling asleep, night waking and early waking. Move the dosing time before cutting the dose.
Dosing time: confirm the clock time at every visit; drift in it is the commonest reason this product fails.
Morning function: ask about the before-school hour at each visit; it decides whether to continue.
Cardiovascular: blood pressure and heart rate at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI charted at baseline and every 6 months. Interrupt if the child crosses two major percentile lines.
Mood, psychiatric and tics: at every visit and dose increase. Affect lability ran 22% open-label and drove most discontinuations.
Digital perfusion: inspect fingers and toes at each visit.
Abuse and diversion: pill counts and PDMP check at each refill, per state requirement. An evening dose is unobserved by school.
Laboratory: none routine; LFTs only for jaundice or dark urine.
Efficacy stopping rule: discontinue if a month of dose adjustment brings no improvement.
Discontinuation & Taper
May be stopped abruptly at therapeutic doses; the label gives no taper schedule.
After prolonged use expect withdrawal: dysphoria, fatigue, vivid dreams, sleep change, increased appetite, agitation.
The offset is displaced like the onset. The first medication-free day is the day after the last capsule, not the evening it is skipped.
Drug holidays work, but the capsule to omit is the night before the free day. Priapism has been reported during them.
Pregnancy & Lactation
Pregnancy: Human data insufficient to inform risk. No teratogenicity in rats or rabbits at 2 and 9 times the 100 mg/day maximum; spina bifida in rabbits at 31 times. Stimulants reduce placental perfusion.
Lactation: Present in milk; infant receives 0.16% to 0.7% of the maternal weight-adjusted dose. Monitor for agitation, insomnia, poor feeding and low weight gain. (LactMed 2025)
Lactation, milk supply: Methylphenidate lowers prolactin; large doses may interfere before lactation is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.
Counseling Points
Counsel the family on:
That the capsule does nothing that evening; nothing happens for about 10 hours, by design.
Treating the clock as part of the prescription: a fixed time, adjusted only within 6:30 to 9:30 p.m.
Never taking a forgotten dose in the morning, which would put the peak in the middle of the night.
Keeping the evening meal consistent; a fatty dinner delays next morning's onset by about 2.5 hours.
Watching the before-school hour and reporting on it at the next visit.
Insomnia taking three forms, all reportable, and usually fixed by moving the dosing time rather than stopping.
Appetite suppression: move the largest meal to breakfast and to the evening.
Locked storage, and that sharing a Schedule II medication is a felony.
Advise them to call for:
Chest pain, fainting, or a racing heart that does not settle.
New hallucinations, or new suspicious or fearful thinking.
Sudden emotional swings, panic attacks, or new aggression.
Numbness, coldness, or colour change in the fingers or toes.
A new or markedly worse tic, or a new vocal tic.
Weight loss, or clothes fitting more loosely over a few weeks.
A painful erection lasting more than a few hours, which is a surgical emergency.
New eye pain, blurred vision, or haloes around lights.
Yellowing of the eyes or skin, or dark urine.
References
DailyMed. Jornay PM (methylphenidate hydrochloride) extended-release capsules prescribing information. Ironshore Pharmaceuticals Inc. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d95dede0-b1ff-4489-8f91-3bbe122852bf
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling