Jornay PM

Jornay PM is a prescription medication used to treat symptoms of attention deficit hyperactivity disorder (ADHD).

Jornay PM belongs to a group of drugs called central nervous system (CNS) stimulants, which works by changing the amount of natural substances in the brain to decrease impulsiveness and hyperactivity.

This medication comes in an extended-release capsule. It is taken once daily in the evening between 6:30 p.m. to 9:30 p.m., with or without food. Do not crush, chew, or divide the capsule. Swallow the capsule whole. 

Common side effects of Jornay PM are headache, decreased appetite and trouble sleeping.

Jornay PM is a prescription medication used to treat symptoms of attention-deficit hyperactivity disorder (ADHD) in people 6 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Jornay PM. See the "Drug Precautions" section. 

The most common side effects of methylphenidate products in children, adolescents, and adults with ADHD include:

• decreased appetite
• stomach pain
• irritability
• trouble sleeping
• weight loss
• mood swings (affect lability)
• nausea
• anxiety
• increased heart rate
• vomiting
• dizziness
• increased blood pressure
• indigestion

The most common side effects of JORNAY PM in children age 6 to 12 with ADHD include:

• trouble sleeping
• nausea
• decreased appetite
• mood swings
• restlessness (psychomotor hyperactivity)
• vomiting
• headache

This is not a complete list of Jornay PM side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effects that bother you or that do not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

Tell your doctor about all the medications you take including prescription and non-prescription medicines, vitamins and herbal supplements. Jornay PM and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking methylphenidate.

Your doctor will decide whether Jornay PM can be taken with other medicines. 

Especially tell your doctor if you take: 

• anti-depression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines
• cold or allergy medicines that contain decongestants.

This is not a complete list of Jornay PM drug interactions. Ask your doctor or pharmacist for more information. 

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. 

Do not start any new medicine while taking Jornay PM without talking to your doctor first. 

Jornay PM can cause serious side effects, including:

• Abuse and dependence. Jornay PM contains methylphenidate. Jornay PM, other methylphenidate containing products, and amphetamines, have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Jornay PM.

  • Tell your healthcare provider if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
  • Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
• Heart-related problems, including:
  • sudden death, stroke, and heart attack in adults
  • sudden death in children who have heart problems or heart defects
  • increased blood pressure and heart rate

Your healthcare provider should check you or your child carefully for heart problems before starting Jornay PM. Tell your healthcare provider if you or your child has any heart problems, heart defects, or high blood pressure.

Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Jornay PM.

Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Jornay PM.

• Mental (psychiatric) problems, including:

• new or worse behavior and thought problems
• new or worse bipolar illness
• new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms

Tell your healthcare provider about any mental problems you or your child has, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Jornay PM, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

Do not take Jornay PM if you or your child is:

• allergic to methylphenidate hydrochloride, or any of the ingredients in Jornay PM.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Jornay PM, there are no specific foods that you must exclude from your diet when receiving Jornay PM. 

Before taking Jornay PM, tell your or your child’s healthcare provider about all medical conditions, including if you or your child:

• have heart problems, heart defects, or high blood pressure
• have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
• have circulation problems in fingers or toes
• are pregnant or plan to become pregnant. It is not known whether Jornay PM will harm your unborn baby.

There is a pregnancy registry for females who are exposed to Jornay PM during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Jornay PM and their baby. If you or your child becomes pregnant during treatment with Jornay PM, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961­ 2388.

• are breastfeeding or plan to breastfeed. Jornay PM passes into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with Jornay PM.

Tell your healthcare provider about all of the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Jornay PM and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted during treatment with Jornay PM.

Your healthcare provider will decide whether Jornay PM can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes medicine to treat depression, including MAOIs.

Know the medicines that you or your child takes. Keep a list of the medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine.

Do not start any new medicine during treatment with Jornay PM without talking to your or your child’s healthcare provider first.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Jornay PM will harm your unborn baby. Published studies and post marketing reports on Jornay PM use during pregnancy are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. 

In animal studies, pregnant rats and rabbits were given Jornay PM and no adverse effects were observed. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

The limited published literature, based on five mothers, reports that Jornay PM is present in human milk. There are no reports of adverse effects on the breastfed infants or effects on milk production. 

Long-term neurodevelopmental effects on infants from CNS stimulants exposure is unknown. 

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. 

• Take Jornay PM exactly as prescribed by your healthcare provider.

• Your healthcare provider may change the dose and timing of the Jornay PM dose if needed.

• Take Jornay PM by mouth 1 time each day in the evening between 6:30 p.m. and 9:30 p.m.

• Take Jornay PM at the same time each evening. Jornay PM should not be taken in the morning.

• Jornay PM can be taken with or without food, but take it the same way each time.

• Jornay PM capsules may be swallowed whole, or if Jornay PM capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto applesauce. Make sure to sprinkle all the Jornay PM onto the applesauce. The Jornay PM dose should not be divided.

  • swallow all the applesauce and medicine mixture right away
  • do not chew the applesauce and medicine mixture
  • do not store the applesauce and medicine mixture

• Your healthcare provider may sometimes stop Jornay PM treatment for a while to check for ADHD symptoms.

• If a dose of Jornay PM is missed, it should be taken as soon as you remember the same evening. If you do not remember until the next morning you should not take the dose. Wait until that evening to take the next scheduled dose. A missed dose should not be taken in the morning.

● If you or your child takes too much Jornay PM, call your healthcare provider or go to the nearest hospital emergency room right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Jornay PM (extended release capsule) 

Initial dose of Jornay PM is 20 mg orally once daily in the evening. Dosage may be increased weekly in increments of 20 mg per day up to a maximum daily dose of 100 mg.

If you take too much Jornay PM, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Jornay PM at room temperature between 68°F to 77°F (20°C to 25°C).

• Store Jornay PM in a safe place, like a locked cabinet. Protect from humidity.

• Dispose of remaining, unused, or expired Jornay PM by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Jornay PM with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away Jornay PM in the household trash.

Keep Jornay PM and all medicines out of the reach of children.

Abuse and dependence:

CNS stimulants, including 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 while on therapy.

Long-term abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use because severe depression may occur. Withdrawal following long-term therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.