Jornay PM 20mg ER Capsules
WARNING: This drug has a high risk of misuse. This can lead to alcohol or drug use disorder. Misuse or abuse of this drug can lead to overdose or death. The risk is higher with higher doses or when used in ways that are not approved like snorting or injecting it. Do not give this drug to anyone else. This drug may be habit-forming if taken for a long time. Do not take for longer than you have been told by your doctor. Use only as you were told. Tell your doctor if you have ever had alcohol or drug use disorder. You will be watched closely while taking this drug.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs as you have been told. @ COMMON USES: It is used to treat attention deficit problems with hyperactivity.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Central Nervous System (CNS) Stimulant
Pharmacologic Class
Norepinephrine-Dopamine Reuptake Inhibitor (NDRI)
Pregnancy Category
Not available
FDA Approved
Aug 2018
DEA Schedule
Schedule II
Overview
What is this medicine?
Jornay PM is an extended-release capsule taken in the evening to help manage symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) the next morning and throughout the day. It works by affecting certain natural substances in the brain that control attention and impulsivity.
How to Use This Medicine
Taking Your Medication
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the evening, as taking it in the morning is not recommended. You can take this medication with or without food, but be consistent in how you take it each time. If you choose to take it with food, always take it with food. If you choose to take it on an empty stomach, always take it on an empty stomach.
If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce. However, do not chew the mixture. After mixing, take your dose immediately. Do not prepare a dose ahead of time or store it for later use.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep your medication safe. Keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, ask your pharmacist about the best way to dispose of your medication. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember if it is still the same evening. If you do not remember until the next morning, skip the missed dose and resume your regular evening dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the evening, as taking it in the morning is not recommended. You can take this medication with or without food, but be consistent in how you take it each time. If you choose to take it with food, always take it with food. If you choose to take it on an empty stomach, always take it on an empty stomach.
If you have trouble swallowing the capsule, you can sprinkle its contents onto applesauce. However, do not chew the mixture. After mixing, take your dose immediately. Do not prepare a dose ahead of time or store it for later use.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. To prevent accidental ingestion, store your medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep your medication safe. Keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, ask your pharmacist about the best way to dispose of your medication. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember if it is still the same evening. If you do not remember until the next morning, skip the missed dose and resume your regular evening dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take Jornay PM once daily in the evening, between 6:30 PM and 9:30 PM, to ensure it works when you wake up.
- Take it consistently at the same time each evening.
- Swallow the capsule whole. If you cannot swallow the capsule, you may open it and sprinkle the contents over applesauce. Swallow the applesauce mixture immediately without chewing.
- Do not crush, chew, or divide the capsule or its contents.
- Avoid alcohol, as it may cause the medication to be released too quickly.
- Maintain regular sleep patterns and a healthy diet.
- Engage in regular physical activity.
- Attend all scheduled doctor appointments for monitoring.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg orally once daily in the evening (between 6:30 PM and 9:30 PM)
Dose Range:
20 - 100 mg
Condition-Specific Dosing:
ADHD:
Initial 20 mg once daily in the evening. May increase by 10-20 mg weekly to a maximum of 100 mg/day. Dose should be individualized based on patient response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 6-12 years: Initial 20 mg orally once daily in the evening (between 6:30 PM and 9:30 PM). May increase by 10-20 mg weekly to a maximum of 100 mg/day.
Adolescent:
For patients 13-17 years: Initial 20 mg orally once daily in the evening (between 6:30 PM and 9:30 PM). May increase by 10-20 mg weekly to a maximum of 100 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; consider lower initial doses and slower titration due to potential for increased exposure. Monitor for adverse effects.
Dialysis:
Not available; methylphenidate is not significantly dialyzable.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; consider lower initial doses and slower titration due to potential for increased exposure. Monitor for adverse effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic efficacy in ADHD is thought to be due to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30% (due to first-pass metabolism)
Tmax:
Biphasic: First peak 10-14 hours post-dose, second peak 14-17 hours post-dose (for Jornay PM)
FoodEffect:
Food does not significantly alter the overall absorption (AUC) of methylphenidate from Jornay PM, but may slightly delay the initial rise in plasma concentrations.
Distribution:
Vd:
Approximately 2.65 L/kg
ProteinBinding:
Approximately 15% (to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 2-3 hours (for methylphenidate itself; Jornay PM provides extended release)
Clearance:
Approximately 0.53 L/hr/kg
ExcretionRoute:
Primarily renal (90% as ritalinic acid, 1% as unchanged drug)
Unchanged:
Less than 1%
Pharmacodynamics
OnsetOfAction:
Delayed (designed to provide effect the morning after evening dosing, typically 10-14 hours post-dose)
PeakEffect:
14-17 hours post-dose (second peak)
DurationOfAction:
Approximately 12 hours (effective duration of action after morning onset)
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including JORNAY PM, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence during treatment.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Sudden deaths have occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly.
If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.
Additional Urgent Side Effects
If you experience a painful erection (priapism) or an erection that lasts longer than 4 hours, seek medical attention right away. This can occur even when you are not having sex, and if left untreated, may lead to lasting sexual problems.
New or worsening behavioral and mood changes, such as changes in thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek medical help immediately if you experience agitation, changes in balance, confusion, hallucinations, fever, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, or severe headache.
Other Side Effects
Not everyone will experience side effects, and many people may only have minor side effects. However, if you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Feeling sleepy
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous and excitable
Trouble sleeping
* Nose or throat irritation
This is not a comprehensive list of all possible side effects. If you have questions about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe headache, dizziness, or fainting
Joint pain
Purple patches on the skin or mouth
Changes in eyesight or eye pain, swelling, or redness
Seizures
Shakiness
Trouble controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color, including pale, blue, gray, purple, or red discoloration of hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Sudden deaths have occurred in people with certain heart problems or defects. If you have a heart condition or defect, inform your doctor. Also, notify your doctor if a family member has an abnormal heartbeat or died suddenly.
If you experience any signs of heart problems, such as chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting, seek medical help immediately.
Additional Urgent Side Effects
If you experience a painful erection (priapism) or an erection that lasts longer than 4 hours, seek medical attention right away. This can occur even when you are not having sex, and if left untreated, may lead to lasting sexual problems.
New or worsening behavioral and mood changes, such as changes in thinking, anger, or hallucinations, have been reported with this medication. If you or a family member have a history of mental or mood problems, such as depression or bipolar disorder, or if a family member has committed suicide, inform your doctor. Seek medical help immediately if you experience hallucinations, changes in behavior, or signs of mood changes, including depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life.
A severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other medications. Seek medical help immediately if you experience agitation, changes in balance, confusion, hallucinations, fever, fast or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, or severe headache.
Other Side Effects
Not everyone will experience side effects, and many people may only have minor side effects. However, if you experience any of the following side effects or any other side effects that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Feeling sleepy
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous and excitable
Trouble sleeping
* Nose or throat irritation
This is not a comprehensive list of all possible side effects. If you have questions about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Chest pain, shortness of breath, or fainting (seek immediate medical attention)
- New or worsening aggressive behavior or hostility
- Seeing or hearing things that are not real (hallucinations)
- Believing things that are not true (delusions)
- Feeling unusually excited, irritable, or having extreme mood swings (signs of mania)
- Numbness, coolness, or pain in fingers or toes, or changes in skin color (Raynaud's phenomenon)
- Unexplained wounds on fingers or toes
- Blurred vision or other vision changes
- Unexplained fever, sore throat, or other signs of infection
- Unusual bruising or bleeding
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Your doctor needs to assess the safety of taking this medication with your existing health conditions and medications. Do not start, stop, or adjust the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
If you are currently taking:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Your doctor needs to assess the safety of taking this medication with your existing health conditions and medications. Do not start, stop, or adjust the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Information to Share with Your Healthcare Team
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.
Precautions to Take While Using This Medication
Until you know how this medication affects you, avoid driving and other activities that require your full attention. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* Certain natural products or aids
Potential Effects of Long-Term Use
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect. This is known as tolerance. If you notice that this medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.
Seizure Risk and Other Potential Side Effects
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor. Additionally, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.
Pregnancy, Breast-Feeding, and Fertility
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial to ensure your safety and proper care. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.
Precautions to Take While Using This Medication
Until you know how this medication affects you, avoid driving and other activities that require your full attention. Regularly monitor your blood work, blood pressure, and heart rate as directed by your doctor. You may need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, consult with your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as:
Cough or cold medications
Diet pills
Stimulants
Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
* Certain natural products or aids
Potential Effects of Long-Term Use
If you have been taking this medication for an extended period or at high doses, it may become less effective, and you may require higher doses to achieve the same effect. This is known as tolerance. If you notice that this medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.
Seizure Risk and Other Potential Side Effects
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor. Additionally, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.
Pregnancy, Breast-Feeding, and Fertility
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Vomiting
- Agitation
- Tremors
- Hyperreflexia
- Muscle twitching
- Convulsions (may be followed by coma)
- Confusion
- Hallucinations
- Delirium
- Sweating
- Flushing
- Headache
- Hyperpyrexia (very high fever)
- Tachycardia (fast heart rate)
- Palpitations
- Cardiac arrhythmias
- Hypertension (high blood pressure)
- Mydriasis (dilated pupils)
- Dry mouth and mucous membranes
What to Do:
Call 911 or your local poison control center immediately (e.g., 1-800-222-1222 in the US). Seek emergency medical attention. Management includes supportive care, maintaining airway, monitoring vital signs, and controlling hyperpyrexia and convulsions.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of discontinuing an MAOI due to risk of hypertensive crisis.
Major Interactions
- Vasopressor agents: Use with caution; methylphenidate may potentiate the pressor effect.
- Halogenated anesthetics: Risk of sudden blood pressure and heart rate increases during surgery; discontinue Jornay PM on the day of surgery.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, tramadol, buspirone, St. John's Wort): Increased risk of serotonin syndrome.
- Antihypertensive drugs: May reduce the effectiveness of antihypertensive drugs.
Moderate Interactions
- Coumarin anticoagulants: May decrease the metabolism of coumarin anticoagulants, requiring dose adjustment.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone): May inhibit the metabolism of these drugs, requiring dose adjustment.
- Tricyclic antidepressants (TCAs): May inhibit the metabolism of TCAs, requiring dose adjustment.
- Dopaminergic drugs (e.g., antipsychotics): Potential for pharmacodynamic antagonism.
Minor Interactions
- Alcohol: May lead to a more rapid release of methylphenidate from extended-release formulations.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: CNS stimulants can cause increases in BP and HR.
Timing: Prior to initiation of treatment.
Height and Weight
Rationale: Monitor for growth suppression in pediatric patients.
Timing: Prior to initiation of treatment.
Psychiatric History (including family history of suicide, bipolar disorder, or depression)
Rationale: Assess for pre-existing psychiatric conditions that may be exacerbated or new psychiatric symptoms that may emerge.
Timing: Prior to initiation of treatment.
Cardiac History (including family history of sudden death or ventricular arrhythmia)
Rationale: Assess for underlying cardiac conditions that may increase risk of sudden death.
Timing: Prior to initiation of treatment.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each dose adjustment and at least every 3-6 months.
Target: Within normal limits for age/sex; significant increases should prompt evaluation.
Action Threshold: Sustained clinically significant increases in BP or HR; consider dose reduction or discontinuation.
Height and Weight
Frequency: Every 3 months for pediatric patients.
Target: Normal growth trajectory.
Action Threshold: Persistent growth deceleration; consider drug holiday or alternative treatment.
ADHD Symptom Control
Frequency: Regularly (e.g., monthly initially, then every 3-6 months).
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms; consider dose adjustment or alternative treatment.
Emergence or Worsening of Psychiatric Symptoms (e.g., psychosis, mania, aggression, anxiety, depression)
Frequency: Regularly (e.g., at each visit).
Target: Absence of new or worsening symptoms.
Action Threshold: New or worsening symptoms; consider dose reduction, discontinuation, or psychiatric consultation.
Circulation in Digits (e.g., Raynaud's phenomenon)
Frequency: Periodically, especially if symptoms reported.
Target: Normal circulation.
Action Threshold: New onset or worsening of peripheral vasculopathy; consider discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- Unexplained fainting
- New or worsening aggressive behavior
- New or worsening psychotic symptoms (e.g., hallucinations, delusions)
- New or worsening manic symptoms (e.g., elevated mood, grandiosity, decreased need for sleep)
- Severe anxiety or agitation
- Depressed mood or suicidal ideation
- Numbness, coolness, or pain in fingers or toes
- Skin color changes in fingers or toes (e.g., pale, blue, red)
Special Patient Groups
Pregnancy
Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are potential risks to the fetus from maternal use of stimulants during pregnancy, such as premature delivery and low birth weight. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No clear evidence of increased risk of major birth defects.
Second Trimester:
No clear evidence of increased risk.
Third Trimester:
Potential for premature delivery and low birth weight.
Lactation
Methylphenidate is present in human milk. There are no data on the effects of methylphenidate on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for JORNAY PM and any potential adverse effects on the breastfed infant from JORNAY PM or from the underlying maternal condition. Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain.
Infant Risk:
Low to moderate risk; monitor infant for adverse effects.
Pediatric Use
Approved for patients 6 years and older. Monitor growth (height and weight) regularly, as stimulants can be associated with growth suppression. Monitor for emergence or worsening of psychiatric symptoms.
Geriatric Use
Safety and efficacy have not been established in geriatric patients. Use with caution, generally starting at the low end of the dosing range, due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Jornay PM is unique among methylphenidate formulations as it is designed for evening administration to provide therapeutic effect the following morning, addressing the common issue of early morning ADHD symptoms.
- The delayed-release mechanism (Delexis®) ensures a significant delay before the drug is released, making the timing of the evening dose crucial (between 6:30 PM and 9:30 PM).
- Patients should be educated that the medication will not have an immediate effect after taking it in the evening.
- It can be taken with or without food, but consistency in administration time is key.
- Consider a drug holiday if growth suppression is observed in pediatric patients, or if long-term efficacy wanes.
Alternative Therapies
- Other extended-release methylphenidate formulations (e.g., Concerta, Quillivant XR, Adhansia XR, Aptensio XR, Ritalin LA, Daytrana patch)
- Immediate-release methylphenidate (e.g., Ritalin, Methylin)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Mydayis, Dexedrine)
- Non-stimulant medications (e.g., Atomoxetine, Guanfacine ER, Clonidine ER)
- Behavioral therapy and psychotherapy
Cost & Coverage
Average Cost:
$300 - $500+ per 30 capsules (20mg-100mg strengths)
Insurance Coverage:
Tier 2 or Tier 3 (Specialty/Non-Preferred Brand)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.