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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

  1. 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
  2. LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
  3. FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
  4. AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
  5. 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/
  6. DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling
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