Jornay PM 80mg 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
Feb 2019
DEA Schedule
Schedule II
Overview
What is this medicine?
Jornay PM is an extended-release capsule used to treat Attention Deficit Hyperactivity Disorder (ADHD). Unlike most ADHD medicines, you take Jornay PM in the evening, usually between 6:30 PM and 9:30 PM. It's designed to start working the next morning when you wake up, helping with focus and behavior throughout the day.
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. Always take it with food or always take it on an empty stomach to maintain consistency.
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 and do not store it for later use.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom. Keep the medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep it safe. Also, keep all medications away from 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, check with your pharmacist for the best disposal method. You may also want to inquire about 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. However, if you do not remember until the next morning, skip the missed dose and resume your normal evening dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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. Always take it with food or always take it on an empty stomach to maintain consistency.
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 and do not store it for later use.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and in a dry place. Avoid storing it in a bathroom. Keep the medication in a safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep it safe. Also, keep all medications away from 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, check with your pharmacist for the best disposal method. You may also want to inquire about 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. However, if you do not remember until the next morning, skip the missed dose and resume your normal evening dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take Jornay PM consistently every evening at the same time, as directed by your doctor.
- Do not chew, crush, or dissolve the capsules. Swallow them whole. If you cannot swallow the capsule, you can open it and sprinkle the beads over a small amount of applesauce or other soft food and swallow immediately without chewing.
- Avoid alcohol consumption, as it can affect the release of the medication and increase side effects.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regularly monitor your blood pressure, heart rate, and weight as advised by your doctor.
- Report any new or worsening psychiatric symptoms (e.g., anxiety, agitation, hallucinations) or cardiovascular symptoms (e.g., chest pain, shortness of breath) immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 20 mg orally once daily in the evening (6:30 PM to 9:30 PM), titrated weekly in 20 mg increments. Max 100 mg/day.
Dose Range:
20 - 100 mg
Condition-Specific Dosing:
ADHD:
Initial dose 20 mg orally once daily in the evening, titrated weekly in 20 mg increments based on clinical response and tolerability. Max 100 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For patients 6-12 years: Initial dose 20 mg orally once daily in the evening (6:30 PM to 9:30 PM), titrated weekly in 20 mg increments. Max 100 mg/day.
Adolescent:
For patients 13-17 years: Initial dose 20 mg orally once daily in the evening (6:30 PM to 9:30 PM), titrated weekly in 20 mg increments. Max 100 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended; use with caution due to limited data.
Dialysis:
Not available; use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended; use with caution due to limited data.
Confidence:
Medium
Pharmacology
Mechanism of Action
Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effect in Attention Deficit Hyperactivity Disorder (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:
Not precisely quantified for ER, but well absorbed.
Tmax:
Approximately 10-12 hours post-dose (due to delayed release for morning effect).
FoodEffect:
Minimal effect on absorption or Tmax; can be taken with or without food.
Distribution:
Vd:
Approximately 2.65 L/kg (for d-methylphenidate).
ProteinBinding:
Approximately 15% (d-methylphenidate) to 12% (l-methylphenidate).
CnssPenetration:
Yes, readily penetrates the blood-brain barrier.
Elimination:
HalfLife:
Approximately 2-3 hours (for methylphenidate, but Jornay PM's release profile extends effective duration).
Clearance:
Approximately 0.53 L/hr/kg (for d-methylphenidate).
ExcretionRoute:
Renal (primarily as ritalinic acid).
Unchanged:
Less than 1% of the dose is excreted in the urine as unchanged methylphenidate.
Pharmacodynamics
OnsetOfAction:
Delayed, typically providing effect upon waking the next morning (approximately 10-12 hours post-evening dose).
PeakEffect:
Morning/mid-day, following the delayed release.
DurationOfAction:
Approximately 12-13 hours (throughout the school/work day).
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
CNS stimulants, including Jornay PM, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing Jornay PM, and monitor patients for signs of abuse and dependence during therapy.
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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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 vision or eye pain, swelling, or redness
Seizures
Shakiness
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color (pale, blue, gray, purple, or red) on 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, balance problems, 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. Seek immediate medical help if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
If you experience a painful erection (hard penis) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood problems (e.g., depression, bipolar illness) or if a family member has committed suicide, inform your doctor. Seek immediate medical help if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical help 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
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous and excitable
Difficulty sleeping
Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns 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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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 vision or eye pain, swelling, or redness
Seizures
Shakiness
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color (pale, blue, gray, purple, or red) on 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, balance problems, 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. Seek immediate medical help if you experience:
+ Chest pain
+ Abnormal heartbeat
+ Shortness of breath
+ Severe dizziness or fainting
If you experience a painful erection (hard penis) or an erection lasting longer than 4 hours, seek medical help right away. This can occur even when not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction.
New or worsening behavioral and mood changes, such as:
+ Changes in thinking
+ Anger
+ Hallucinations
If you or a family member have a history of mental or mood problems (e.g., depression, bipolar illness) or if a family member has committed suicide, inform your doctor. Seek immediate medical help if you experience:
+ Hallucinations
+ Changes in behavior
+ Signs of mood changes, such as depression, thoughts of suicide, nervousness, emotional ups and downs, abnormal thinking, anxiety, or loss of interest in life
A potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. Seek immediate medical help 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
+ Severe headache
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous and excitable
Difficulty sleeping
Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns 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 (signs of heart problems)
- New or worsening high blood pressure
- New or worsening mental problems (e.g., seeing or hearing things that are not real, believing things that are not true, suspiciousness, aggression)
- New or worsening bipolar illness or mania
- New or worsening tics or Tourette's syndrome
- Numbness, pain, skin color change, or sensitivity to temperature in fingers or toes (Raynaud's phenomenon)
- Unexplained weight loss or slowed growth in children
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
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Current use of certain medications, such as:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dose of any medication without consulting 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
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
Current use of certain medications, such as:
+ Linezolid
+ Methylene blue
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health status. Never start, stop, or adjust the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to undergo surgery, be sure to discuss this with your doctor beforehand.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may need to undergo certain heart tests before starting this medication; if you have any questions or concerns, consult with your doctor.
While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is crucial to discuss with your doctor the potential risks of 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, and certain natural products or aids.
Long-term use or high doses of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that this medication is no longer working as well as it should, contact your doctor. Do not exceed the prescribed dose.
This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of experiencing seizures while taking this medication.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary; discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to weigh the benefits and risks of this medication for both you and your baby.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may need to undergo certain heart tests before starting this medication; if you have any questions or concerns, consult with your doctor.
While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these substances with this medication may cause nervousness, shakiness, and a rapid heartbeat.
If you have high blood pressure, it is crucial to discuss with your doctor the potential risks of 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, and certain natural products or aids.
Long-term use or high doses of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that this medication is no longer working as well as it should, contact your doctor. Do not exceed the prescribed dose.
This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of experiencing seizures while taking this medication.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary; discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Vomiting
- Agitation
- Tremors
- Hyperreflexia
- Muscle twitching
- Convulsions (may be followed by coma)
- Euphoria
- 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 mucous membranes
- Rhabdomyolysis
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage, activated charcoal, and management of symptoms (e.g., benzodiazepines for agitation/seizures, alpha-blockers for hypertension).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of MAOI discontinuation due to risk of hypertensive crisis.
Major Interactions
- Vasopressor agents (e.g., phenylephrine, pseudoephedrine) - risk of increased blood pressure.
- Halogenated Anesthetics - risk of sudden blood pressure and heart rate increases during surgery.
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
- Antihypertensive Drugs - methylphenidate may reduce the effectiveness of drugs used to treat hypertension.
Moderate Interactions
- Coumarin Anticoagulants (e.g., warfarin) - may prolong prothrombin time.
- Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing plasma concentrations.
- Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing plasma concentrations.
Confidence Interactions
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To identify pre-existing cardiovascular conditions and establish baseline for monitoring stimulant-induced changes.
Timing: Prior to initiation of therapy.
Height and Weight
Rationale: To establish baseline for monitoring growth suppression, especially in pediatric patients.
Timing: Prior to initiation of therapy.
Psychiatric History (including family history of sudden death or serious cardiac disease)
Rationale: To assess risk of psychiatric adverse events (e.g., psychosis, mania) and identify cardiac risk factors.
Timing: Prior to initiation of therapy.
Cardiac History (including ECG if clinically indicated)
Rationale: To screen for structural cardiac abnormalities or other serious heart problems.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: At each visit or at least every 3-6 months.
Target: Within normal limits for age; significant increases should prompt evaluation.
Action Threshold: Sustained clinically significant increases (e.g., >10-20 mmHg systolic/diastolic, >10-20 bpm HR) warrant dose reduction or discontinuation.
Height and Weight
Frequency: Every 3-6 months in pediatric patients; periodically in adults.
Target: Normal growth trajectory for age.
Action Threshold: Significant growth deceleration or weight loss warrants evaluation and potential dose adjustment or drug holiday.
ADHD Symptom Control
Frequency: At each visit.
Target: Improved attention, reduced hyperactivity/impulsivity.
Action Threshold: Lack of efficacy or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Emergence or Worsening of Psychiatric Symptoms (e.g., psychosis, mania, aggression, tics)
Frequency: At each visit.
Target: Absence of new or worsening symptoms.
Action Threshold: New onset or significant worsening of symptoms warrants immediate evaluation and potential discontinuation.
Symptom Monitoring
- Chest pain
- Shortness of breath
- Syncope
- Palpitations
- Hallucinations
- Delusional thinking
- Mania
- Aggression
- New or worsening tics
- Unexplained weight loss
- Sleep disturbances
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Data from a pregnancy registry suggest an increased risk of cardiac malformations with first-trimester exposure to methylphenidate, but confounding factors limit definitive conclusions.
Trimester-Specific Risks:
First Trimester:
Potential increased risk of cardiac malformations (e.g., ventricular septal defects) based on some registry data, though overall risk appears low and causality is not definitively established.
Second Trimester:
No specific data suggesting unique risks.
Third Trimester:
Potential for premature delivery and low birth weight. Neonates exposed to amphetamines or methylphenidate during the third trimester may experience withdrawal symptoms (e.g., agitation, irritability, poor feeding, tremor, hypertonia, somnolence).
Lactation
Methylphenidate is excreted into human milk. The decision to breastfeed during treatment should consider the developmental and health benefits of breastfeeding, 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.
Infant Risk:
Monitor breastfed infants for agitation, insomnia, anorexia, and reduced weight gain. The relative infant dose is generally low (around 0.2-0.7% of maternal dose).
Pediatric Use
Approved for patients 6 years and older. Monitor growth (height and weight) carefully. Long-term effects on growth are not fully established but growth suppression has been observed with chronic stimulant use. Psychiatric adverse events (e.g., psychosis, mania, aggression) can occur.
Geriatric Use
Jornay PM has not been studied in patients over 65 years of age. Use with caution due to increased susceptibility to cardiovascular effects and other adverse reactions in older adults. Generally not recommended unless benefits clearly outweigh risks.
Clinical Information
Clinical Pearls
- Jornay PM is unique among methylphenidate formulations as it is taken in the evening (6:30 PM to 9:30 PM) to provide effect the following morning, aligning with the natural circadian rhythm and avoiding the need for morning dosing.
- The delayed-release mechanism helps to avoid the 'morning crash' or 'rebound' effect often seen with immediate-release stimulants wearing off overnight.
- Patients should be advised to take Jornay PM consistently at the same time each evening to optimize its delayed-release profile.
- It is crucial to educate patients and caregivers about the evening dosing schedule to prevent accidental morning dosing, which could lead to insomnia.
- Monitor for signs of growth suppression in pediatric patients and cardiovascular effects (BP, HR) in all patients.
- Consider a drug holiday if growth suppression or other significant side effects are observed, under medical supervision.
Alternative Therapies
- Other extended-release methylphenidate formulations (e.g., Concerta, Ritalin LA, Adhansia XR, Aptensio XR, Quillivant XR, QuilliChew ER, Daytrana patch)
- Immediate-release methylphenidate (e.g., Ritalin, Methylin)
- Amphetamine-based stimulants (e.g., Adderall XR, Vyvanse, Dexedrine, Mydayis)
- Non-stimulant medications (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay))
Cost & Coverage
Average Cost:
$300 - $500+ per 30 capsules
Insurance Coverage:
Tier 2 or 3 (Brand-name prescription drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult 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 details about the medication taken, the amount, and the time it occurred.