Pretreatment Screening

Prior to treating pediatric patients and adults with CNS stimulants, including JORNAY PM, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse, dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for JORNAY PM use [see Boxed Warning, Warnings and Precautions (5.1) and Drug Abuse and Dependence (9)].

General Dosing Information

JORNAY PM is given orally once daily in the evening. JORNAY PM should not be taken in the morning.

The recommended starting dose of JORNAY PM for patients 6 years and older is 20 mg once daily in the evening. The dose may be titrated weekly in increments of 20 mg. Daily doses above 100 mg have not been studied and are not recommended.

Initiate dosing at 8:00 p.m. Adjust the timing of administration between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and efficacy the next morning and throughout the day. In clinical trials of patients aged 6 to 12 years, the most common dosing time (>70% of patients) was 8:00 p.m., with an allowed range between 6:30 p.m. and 9:30 p.m. Following determination of the optimal administration time, advise patients to maintain a consistent dosing time.

Patients who miss their dose of JORNAY PM at the regularly scheduled time should take it as soon as they remember that same evening. If a patient remembers the missed dose the following morning, they should skip the missed dose and wait until their next scheduled evening administration.

Advise patients to take JORNAY PM consistently, either with food or without food.

JORNAY PM may be taken whole, or the capsule may be opened, and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken at the same time.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of JORNAY PM and adjust dosage as needed.

Switching from Other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with JORNAY PM using the titration schedule described above.

Do not substitute JORNAY PM for other methylphenidate products on a milligram-per-milligram basis because these products have different pharmacokinetic profiles from JORNAY PM and may have different methylphenidate base composition [see Description (11) and Clinical Pharmacology (12.3)].

Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage or, if necessary, discontinue the drug. JORNAY PM should be periodically discontinued to assess the child's condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue drug.