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JORNAY PM has a safety profile that is consistent
with other methylphenidate products1-3

Adverse reactions occurring in ≥2% of JORNAY PM-treated patients ages 6-12 and greater than placebo in a 3-week ADHD study (Study 2)1

Adverse Reaction JORNAY PM (n=81) Placebo (n=80)
Any insomnia 33% 9%
Initial insomnia 14% 5%
Middle insomnia 11% 4%
Terminal insomnia 11% 1%
Insomnia, not specified 4% 1%
Affect lability/mood swings 6% 1%
Decreased appetite 19% 4%
Headache 10% 5%
Psychomotor hyperactivity 5% 1%
Blood pressure diastolic increased 7% 4%
Vomiting 9% 0%
Nausea 6% 0%
Nasopharyngitis 3% 1%
Pharyngitis streptococcal 3% 0%
Contusion 3% 0%
Back pain 3% 0%
Rash 2% 0%
  • In Pivotal Study 2, all sleep-related adverse events were either mild or moderate in severity. The majority of subjects (83% with JORNAY PM [24/29]; 73% with placebo [8/11]) reported these events as mild3
    • In the JORNAY PM group, sleep-related adverse events were transient and resolved in 97% of subjects (28/29), and no action was taken to reduce the dose in 90% of subjects3
  • 3 patients withdrew from Pivotal Study 1 due to affect lability, panic attacks, and agitation and aggression. One patient in the JORNAY PM group withdrew from Pivotal Study 2 due to mood swings1-3
  • No predicted accumulation upon repeated dosing (based on multiple-dose simulation)8

In clinical trials with JORNAY PM, no patients withdrew from either study due to insomnia or decreased appetite.1-3

During dose optimization in Pivotal Study 1, no trend was observed between
increasing dose and adverse reactions.9
IMPORTANT SAFETY INFORMATION (CONTINUED) ADVERSE REACTIONS
  • The most common (≥5% and twice the rate of placebo) adverse reactions with methylphenidate are decreased appetite, insomnia, nausea, vomiting, dyspepsia, abdominal pain, decreased weight, anxiety, dizziness, irritability, affect lability, tachycardia, and increased blood pressure.
Please see Important Safety Information and Full Prescribing Information, including Boxed Warning.
References