Jornay PM®, the first ADHD medication to be taken at BEDTIME was approved by the he US Food and Drug Administration (FDA) in August 2018.
This is new formulation of methylphenidate and was approved by the FDA for the treatment of ADHD in patients 6 years and older.
Note: The product will not be commercially available to patients until early 2019.
I can hear the reader groaning–Did we really need one more formulation of methylphenidate? What is so unique about this Jornay PM? What is unique is that it is supposed to be taken at bedtime. Why? As we know, mornings are particularly difficult for persons with ADHD, especially the morning medication kicks in.
The manufacturer, Ironshore Pharmaceuticals & Development, Inc., has developed proprietary drug delivery system, which they call Delexis™. There are two useful features of this system:
1. There is an outer delayed-release layer that consists of pH and time dependent polymers. This leads predictably to the release in the medication starting about 10 hours later.
2. It also has of an inner layer consisting of polymers that regulate permeability and tightly control dissolution of the medication. This leads to the medication being released slowly throughout the next day.
So, Jornay PM is BOTH delayed-release AND extended-release.
It is recommended that Jornay PM be taken around 8 pm every night. The timing can than be adjusted between 6:30 pm to 9:30 pm depending on the effect in that patient.
The capsules will be available in 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg strengths.
Two randomized, double-blind, placebo-controlled studies were done in 278 children 6 to 12 years of age who had ADHD.These studies showed that Jornay PM did do the two things it was supposed to do–improve symptoms throughout the day and improve symptoms in the early mornings.
In addition to standard rating scales for ADHD symptoms during the day, to specifically assess morning symptoms, the studies used:
1. The morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale, and
2. The Before School Functioning Questionnaire (BSFQ).
As of August 2018, these studies have not been published anywhere and Simple and Practical Mental Health is unable to independently evaluate the data. We are only summarizing what has been made publicly available.
Here is the announcement from the company about the FDA approval:
Here is a link to the Prescribing Information for Jornay PM:
Faraone SV, Childress A, Wigal SB, Kollins SH, McDonnell MA, DeSousa NJ,
Sallee FR. Reliability and Validity of the Daily Parent Rating of Evening and
Morning Behavior Scale, Revised. J Atten Disord. 2018 Sep;22(11):1066-1073. PubMed PMID: 26700792.
Faraone SV, Schachar RJ, Barkley RA, Nullmeier R, Sallee FR. Early Morning
Functional Impairments in Stimulant-Treated Children with Attention Deficit/Hyperactivity Disorder Versus Controls: Impact on the Family. J
Child Adolesc Psychopharmacol. 2017 Oct;27(8):715-722. PubMed PMID: 28394175; PubMed Central PMCID: PMC5651955.
Sallee FR. Early Morning Functioning in Stimulant-Treated Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, and its Impact on Caregivers. J Child Adolesc Psychopharmacol. 2015 Sep;25(7):558-65. PubMed PMID: 26151738; PubMed Central PMCID: PMC4576958.
Copyright © 2018, Simple and Practical Mental Health. All rights reserved. May not be reproduced in any form without express written permission.
Disclaimer: The content on this website is provided as general education for medical professionals. It is not intended or recommended for patients or other laypersons or as a substitute for medical advice, diagnosis, or treatment. Patients must always consult a qualified health care professional regarding their diagnosis and treatment. Healthcare professionals should always check this website for the most recently updated information.