Jornay PM

Primary Indication

Jornay PM is used for the treatment of attention deficit hyperactivity disorder (ADHD). It is a central nervous system (CNS) stimulant that helps improve focus and decrease impulsivity and hyperactivity.

Symptom Management

This medication is prescribed to help manage the core symptoms associated with ADHD, including:

• Inattention (difficulty staying on task or following instructions).
• Hyperactivity (fidgeting or inability to sit still).
• Impulsivity (acting or speaking without thinking).

Unique Timing and Use

Jornay PM is unique because it is taken in the evening rather than the morning. It is designed with a delayed-release coating that prevents the medication from being absorbed immediately. This allows the drug to begin working the following morning, providing symptom control when the patient wakes up and continuing throughout the day.

Patient Population

Healthcare providers may prescribe Jornay PM for:

• Children 6 years of age and older.
• Adolescents.
• Adults.

It is intended to be used as part of a total treatment program for ADHD that may also include counseling, behavioral therapy, or other educational supports.

Mechanism of Action

Jornay PM contains methylphenidate, a stimulant that affects the central nervous system. While the exact way it works to treat Attention Deficit Hyperactivity Disorder (ADHD) is not fully understood, it is believed to influence how the brain processes certain chemicals called neurotransmitters.

The medication primarily targets two neurotransmitters:

• Dopamine: A chemical involved in motivation, reward, and movement.
• Norepinephrine: A chemical that affects attention and responding actions.

By blocking the reabsorption of these chemicals back into the brain's nerve cells, Jornay PM increases their availability in the spaces between cells. This helps improve focus, concentration, and impulse control.

Delayed-Release Technology

Unlike many other ADHD medications that are taken in the morning, Jornay PM is designed to be taken in the evening. It uses a specialized two-layer coating system:

• The first layer delays the initial release of the drug for approximately 10 to 12 hours, allowing the patient to sleep without the stimulant effects.
• The second layer provides a controlled, extended release of the medication throughout the following day.

This delivery method is intended to ensure the medication is active in the body when the patient wakes up and continues to work during daytime hours.

Common Side Effects

The most frequently reported side effects of Jornay PM include:

• Decreased appetite
• Trouble sleeping (insomnia)
• Nausea or vomiting
• Stomach pain
• Weight loss
• Anxiety or irritability
• Dizziness
• Increased heart rate
• Mood swings

Serious Side Effects

While less common, some side effects can be serious. Seek medical attention immediately if you experience:

• Heart-related problems: Chest pain, shortness of breath, or fainting.
• Psychiatric symptoms: Hearing voices, seeing things that are not there, or new feelings of suspicion and paranoia.
• Circulation issues: Numbness, pain, or skin color changes (pale, blue, or red) in the fingers or toes.
• Prolonged erections: Painful or long-lasting erections (priapism) require urgent medical care.
• High blood pressure: Significant increases in blood pressure or heart rate.

In children, methylphenidate products may cause a temporary slowing of growth. Healthcare providers typically monitor height and weight during treatment to ensure the child is developing as expected.

Boxed Warning: Abuse and Dependence

Jornay PM has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of stimulants can result in overdose and death. Healthcare providers typically assess the risk of abuse before prescribing and monitor patients for signs of misuse and dependence during treatment.

Contraindications

This medication should not be used in individuals who:

• Are currently taking a monoamine oxidase inhibitor (MAOI) or have taken one within the last 14 days, as this can cause a dangerously high increase in blood pressure.
• Have a known hypersensitivity to methylphenidate or any other ingredients in the formulation.

Cardiovascular Risks

Serious cardiovascular events, including sudden death, stroke, and heart attack, have been reported in adults taking stimulant medications. Sudden death has also occurred in children and adolescents with structural heart abnormalities or other serious cardiac conditions. Because stimulants can increase blood pressure and heart rate, regular monitoring is usually required. This medication should be used with caution in patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate.

Psychiatric Risks

Stimulants may exacerbate symptoms in patients with pre-existing psychotic disorders or bipolar disorder. In some cases, these medications may cause new psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in patients without a prior history of these conditions. Patients should also be monitored for the emergence or worsening of aggressive behavior or hostility.

Additional Precautions

• Priapism: Prolonged and sometimes painful erections have been reported with methylphenidate products. This is a medical emergency that requires immediate attention.
• Peripheral Vasculopathy: Stimulants are associated with circulation problems in the fingers and toes, such as Raynaud's phenomenon. Symptoms may include numbness, pain, or skin color changes.
• Growth Suppression: Long-term use of stimulants in children may lead to a temporary slowing of growth in height and weight. Healthcare providers typically monitor growth during treatment.
• Alcohol Interaction: Alcohol should be avoided while taking Jornay PM. Consuming alcohol can cause the medication to be released into the bloodstream too rapidly, which may increase the risk of adverse effects.

Pregnancy

There is limited information regarding the safety of Jornay PM in pregnant individuals. Animal studies have indicated that high doses of methylphenidate may cause developmental issues, but human data is insufficient to confirm these risks. Healthcare providers generally advise using this medication during pregnancy only when the benefits to the parent are greater than the potential risks to the fetus.

A pregnancy registry exists to collect information about the health of individuals who take ADHD medications during pregnancy and the health of their babies. Patients are encouraged to talk to their doctor about participating in such registries to help improve medical knowledge.

Breastfeeding

Methylphenidate, the active ingredient in Jornay PM, passes into breast milk in small amounts. The effects of this exposure on a nursing infant are not well-documented. If you are breastfeeding while taking this medication, it is important to monitor the infant for potential side effects, such as:

• Increased irritability or agitation
• Trouble sleeping
• Poor weight gain or feeding issues

The decision to breastfeed while using this medication involves weighing the benefits of breastfeeding against the mother's clinical need for the drug. Consult with a healthcare provider to determine the best course of action for your specific situation.

Dosage Forms

Jornay PM is supplied as an oral extended-release capsule. The medication is contained within beads that have specialized coatings to manage the timing of the drug's release.

Administration

• The capsules are typically swallowed whole.
• Alternatively, the capsule may be opened and its contents sprinkled onto a spoonful of applesauce for those who cannot swallow the capsule whole.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Jornay PM for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. It is a delayed-release and extended-release formulation of methylphenidate hydrochloride, designed to be taken in the evening to provide symptom control the following morning and throughout the day.

Boxed Warning

Jornay PM contains a boxed warning, which is the most serious warning required by the FDA. This warning states that CNS stimulants, including Jornay PM, have a high potential for abuse and dependence. Healthcare providers are advised to assess the risk of abuse prior to prescribing and to monitor patients for signs of misuse and dependence during treatment.

Controlled Substance Status

Jornay PM is classified by the Drug Enforcement Administration (DEA) as a Schedule II (CII) controlled substance. This designation is due to the medication's high potential for abuse, which may lead to severe psychological or physical dependence.

Regulatory Safety Requirements

As part of its regulatory status, the FDA requires that a Medication Guide be provided to patients or caregivers each time the medication is dispensed. This guide provides essential information regarding the risks of serious cardiovascular events, psychiatric adverse reactions, and the potential for growth suppression in pediatric patients.

Withdrawal Symptoms

If Jornay PM is stopped abruptly after regular or high-dose use, withdrawal symptoms may occur. These symptoms are often the result of the body adjusting to the absence of the stimulant medication. Common withdrawal effects include:

• Extreme tiredness or fatigue
• Depression or significant mood changes
• Sleep problems, such as insomnia or oversleeping
• Increased appetite
• Irritability

Safe Discontinuation

Jornay PM is a Schedule II controlled substance, which means it carries a risk of dependence. To avoid or reduce withdrawal symptoms, healthcare providers usually recommend gradually lowering the dose rather than stopping the medication all at once. It is important to follow a doctor's specific instructions for tapering off the drug to ensure safety and monitor for any returning symptoms of ADHD.