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Friday, August 10, 2018

Jornay PM for ADHD

Although Jornay PM (Ironshore Pharmaceuticals) (methylphenidate) is marketed as the first bedtime medication for ADHD, it is in fact, not quite all that.  Guanfacine (Intuniv,    ) and clonidine are often given at bedtime and treat symptoms during the day as well.  Jornay isn't even the first stimulant that can be given at bedtime.  Mydayis is actually the first and has been on the market for several months.  However, Jornay PM is the first stimulant that can be given to children at bedtime (unfortunately Mydayis caused a high rate of insomnia and appetite suppression in children and so is unlikely to ever be available for kids).  And anyone who knows what it's like to struggle with ADHD in the morning can tell you, the potential to have a medication work first thing in the morning could be a game changer.

Disadvantages
Cost.  Like any new medication  Jornay PM is likely to be expensive while it is under patent.  It is yet to be seen what type of assistance, if any, Ironshore Pharmaceuticals, will offer to patients.  Also, during the first year after approval, insurance companies are unlikely to cover any new medication unless it is truely unique, which it is not.
Nothing new.  This drug does not really offer anything new in terms of avoiding potential risks.   It is still causes issues with appetite, sleep, anxiety, emotionality, and other symptoms commonly associated with stimulants in some patients.  In addition, preliminary studies showed up to a 33-41% chance of insomnia in 6 weeks of treatment.  Similar studies done with Concerta showed up to a 12% chance of insomnia.  Since the studies were not done as direct comparisons, it's difficult to know how the risk for insomnia truly compares, but 33% seems high.
Takes longer for it to get out of your system.   If side effects are likely, the big advantage of stimulants is that they are out of your system quickly.  This would not be out of your system very quickly, although likely if your child has severe side effects, such as hallucinations, it would not be more than 24 hours (as compared to 12 with Concerta).
Drug levels likely to take a long time to stabilize.  Clinical studies have not actually addressed this issue, but we often see that long acting drugs often manifest side effects later in the game--6 to 8 weeks later.  We would not expect things to be different with this drug.
Difficult to deal with missing doses.  If you miss a dose, you'll definitely have to wait until the next day.  It would be possible to take a short acting medication to cover the gap, but obviously your morning would still suffer.

Advantages
Works in the morning.  The main advantage of Journay PM is that it allows patients to have the benefit of their stimulant from the time when they wake up, onward through the day.  No waiting for your med to kick in before you can really function.  No more difficult mornings.
Different.  As with any new formulation, a different time release can produce advantages for some patients.  The let down off of Jornay PM may minimize symptoms of rebound, for example. 

Should your child use Jornay PM?
Jornay does not really have an advantage over traditional long acting meds like Concerta except for the hour that it takes a traditional medication to get started.  If mornings are manageable with behavioral strategies, this medication probably would not be worth the cost or the potential for side effects lasting through the night.  However, if your child is truly unmanageable in the mornings before meds and the extra hour of medication effect is worth it to you, then this medication could be helpful.

Should adults with ADHD use Jornay PM?
Adults who really struggle with mornings to the point of being late for work, and who have no one at home to make sure they get out of the house in a timely fashion may find Jornay PM to be helpful.  Jornay PM, unlike Mydayis, is a member of the methylphenidate family and so may be more appealing to patients who find methylphenidate more effective than Adderall.

References:
Jornay PM [package insert]. Ironshore Pharmaceuticals.,  Grand Cayman; Aug 2018.  http://www.ironshorepharma.com/labeling.pdf.  Accessed 8/10/2018.

Mydayis [package insert]. Shire, LLC., Lexington, MA; June 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf.  Accessed November 19, 2017

Concerta [package insert]. Jannsen Pharmaceuticals, Inc.,  Titusville, NJ; Dec 2013.   https://www.janssenmd.com/pdf/concerta/concerta_pi.pdf.  Accessed 8/10/2018.

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