Jornay PM

Jornay PM is a once-a-day capsule used to treat attention deficit hyperactivity disorder (ADHD). It contains a central nervous system (CNS) stimulant called methylphenidate hydrochloride.

It's not known exactly how Jornay PM works in people with ADHD, but it is a stimulant that increases activity in the brain, especially in the areas that help regulate behavior and attention. It helps to boost the levels of dopamine and noradrenaline, which are chemical messengers (neurotransmitters), by preventing their re-uptake from the space between nerve cells (neurons) in the brain. Low levels of these chemical messengers have been found in people with ADHD.

Jornay PM is taken in the evening. Each capsule contains two layers. The outside layer is designed to delay the release of the drug so that it doesn't start to be released until about 12 hours after it is taken. The inside layer extends the amount of time the drug is released into your body for. The two-layer approach is designed to help ensure Jornay PM is working when you wake up and keeps working during the day.

Medications containing methylphenidate, such as Jornay PM, are schedule II federally controlled substances because they can be a target for people who abuse prescription medicines or street drugs. Selling or giving away Jornay PM may harm others, and is against the law.

Jornay PM was approved for use by the US Food and Drug Administration (FDA) in 2018, although methylphenidate in another formulation was first approved many years earlier in 1955.

Jornay PM is a prescription medicine used for the treatment of ADHD in people 6 years of age and older. It may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.

It is not known if it is safe and effective in children under 6 years of age.

• Take Jornay PM exactly as prescribed by your healthcare provider.
• Your healthcare provider may change the dose and timing of the dose if needed.
• Take by mouth 1 time each day in the evening between 6:30 p.m. and 9:30 p.m.
• Take at the same time each evening. Jornay PM should not be taken in the morning.
• Take with or without food, but take it the same way each time.
• Jornay PM capsules may be swallowed whole, or if the capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto applesauce. Make sure to sprinkle all the contents of the capsule onto the applesauce. The 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 treatment with this medication for a while to check for ADHD symptoms.

Jornay PM can cause serious side effects, including:

• Abuse and dependence. This medication 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 this medication. 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 this medication. 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 this medication. 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.
• 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, 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. See below for a complete list of ingredients.
• taking or has taken within the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

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

Jornay PM can cause serious side effects, including:

• See "Important information" above.
• Painful and prolonged erections (priapism). Priapism has happened in males who take products that contain methylphenidate. If you or your child develops priapism, get medical help right away.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon). Signs and symptoms may include: fingers or toes may feel numb, cool, or painful fingers or toes may change color from pale, to blue, to red Tell your healthcare provider if you or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes. Call your healthcare provider right away if you or your child has any signs of unexplained wounds appearing on fingers or toes during treatment with this medication.
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment. Treatment may be stopped if your child is not gaining weight or height.

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

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

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

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

These are not all the possible side effects of this medication.

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

The recommended starting dose of Jornay PM for patients 6 years and over is 20 mg daily in the evening. The dose may be increased weekly in increments of 20 mg up to a maximum daily dose of 100 mg. Jornay PM should be taken between 6:30 pm and 9:30 pm. The timing of the dose can be adjusted within this window to help reduce side effects and ensure it is working when needed the following day.

See the Full Prescribing Information for further details about Jornay PM dosing.

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.

Avoid drinking alcohol during treatment with Jornay PM. This may cause a faster release of the medicine.

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.

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 without talking to your or your child's healthcare provider first.

Tell your healthcare provider if you 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 this medication 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, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961-2388.

Tell your healthcare provider if you 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 this medication.

• Store Jornay PM at room temperature between 68°F to 77°F (20°C to 25°C).
• Store in a safe place, like a locked cabinet to protect it from theft. Never give it to anyone else, because it may cause death or harm them.
• 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 this medication 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 in the household trash.

Keep out of the reach of children.

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: dibutyl sebacate, diglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer Type B, microcrystalline cellulose, monoglycerides, polysorbate 80, and talc.

The capsule shell of 20 and 40 mg strength capsules contains FD&C Blue #1, hypromellose, titanium dioxide, yellow iron oxide, and black ink for the imprint.

The capsule shell of 60 and 80 mg strength capsules contains FD&C Blue #1, hypromellose, titanium dioxide, and black ink for the imprint. The capsule shell of 100 mg strength capsule contains black iron oxide, FD&C Blue#1, hypromellose, red iron oxide, titanium dioxide, black ink, and white ink for the imprint.

Jornay PM is manufactured for Ironshore Pharmaceuticals Inc.