Dexmethylphenidate Hydrochloride

To evaluate changes in prescription stimulant dispensing to children aged 5 to 17 years associated with the COVID-19 pandemic and the shortage of immediate-release mixed amphetamine salts (Adderall), which was announced in October 2022.

We analyzed the 2017 to 2023 IQVIA Longitudinal Prescription Database, which captures 92% of US prescriptions. Using an interrupted time series design, we evaluated level and slope changes in the monthly stimulant-dispensing rate (number of children with stimulant dispensing per 100 000 children) in March 2020 and October 2022.

In March 2020, the monthly stimulant-dispensing rate to children declined −454.9 children per 100 000 (95% CI, −572.6 to −337.2), an 18.8% decrease relative to January 2017. After March 2020, this rate increased to 12.7 children per 100 000 per month (95% CI, 6.6–18.8). In October 2022, there was no level change (−39.7 children per 100 000; 95% CI, −189.9 to 110.5) or slope change (−12.1 children per 100 000 per month; 95% CI, −27.5 to 3.3), although estimates were negative. During October 2022, there was a level decrease in the monthly dispensing rate for immediate-release mixed amphetamine salts and a level increase in the monthly dispensing rate for dexmethylphenidate.

Stimulant dispensing to children declined after the pandemic began. Dispensing may also have declined after October 2022, but estimates were not significant, partly because decreased dispensing of immediate-release mixed amphetamine salts was offset by increased dispensing of other stimulants. Findings suggest the shortage may have prompted children to switch to alternative stimulants. Future research should evaluate whether any switches led to adverse events.

What is this summary about : This is a plain language summary of 2 articles published in the Journal of Child and Adolescent Psychopharmacol.It describes a medication called serdexmethylphenidate/dexmethylphenidate, or SDX/d-MPH for short.SDX/d-MPH is marketed under the name Azstarys^.It is in capsule form taken by mouth once a day in the morning and meant for treating patients aged 6 years and older with attention-deficit/hyperactivity disorder, commonly referred to as ADHD.This summary focuses on studies that were done in children and adolescents aged 6 to 12 years with ADHD.The study results showed how SDX/d-MPH reduced the symptoms of ADHD, how fast the medication began to work and for how long it worked in the study patients, as well as the medications safety during 1 yr of treatment.What are the key takeaways : Two main studies were done in patients with ADHD.The first study was conducted in a laboratory classroom, which is a simulated school classroom setting with children and adolescents aged 6 to 12 years with ADHD.The patients received either SDX/d-MPH or a placebo.The results of this study showed that the effect of SDX/d-MPH on reducing ADHD symptoms started approx. 30 min after taking the SDX/d-MPH capsule and lasted for approx. 13 h.The placebo did not have this effect.The most common side effects for those taking SDX/d-MPH were headache, abdominal (belly) pain, insomnia and upper respiratory tract infection.The second study was also done in patients aged 6 to 12 years with ADHD.The purpose was to examine how safe and tolerable SDX/d-MPH was during 1 yr of treatment.In this study, no placebo was given.The findings from the second study showed that SDX/d-MPH was safe and tolerable during the 1-yr treatment period, with the most common side effects being decreased appetite, upper respiratory tract Scott H. Kollins1,2, Andrea Marraffino3, Andrew J. Cutler4,5, Charles Oh6, Matthew N. Brams7, Rene Braeckman8 & Ann C. Childress9 1 Duke University School of Medicine, Durham, NC, USA; 2 Akili Interactive, Inc., Boston, MA, USA; 3 Accel Research Sites Network, Maitland, FL, USA; 4 SUNY Upstate Medical University, Syracuse, NY, USA; 5 Neuroscience Education Institute, Lakewood Ranch, FL, USA; 6 Corium LLC, Boston, MA, USA; 7 Bayou City Research, Houston, TX, USA; 8 Zevra Therapeutics Inc, Celebration, FL, USA; 9Center for Psychiatry and Behavioral Medicine, Las Vegas, NV, USA Placebo: an inactive substance that has no medication but looks exactly the same as the actual medication and is taken in exactly the same way as the study drug.Side effect: an undesirable effect of a medication.Insomnia: difficulty sleeping.Tolerable: means that a patient can endure a medication even with the some of the side effects. infection, sore throat and nose, decreased weight and irritability.This study also showed that SDX/d-MPH was effective throughout the 1-yr treatment period.What were the main conclusions : In the first study, children with ADHD treated with SDX/d-MPH showed noticeable improvements in ADHD symptoms as early as 30 min after the medication was given, and those improvements lasted up to 13 h.SDX/d-MPH was also found to be as safe as other ADHD treatments containing methylphenidate (MPH).Results of the second study showed that children with ADHD could be treated safely with SDX/d-MPH.Clin. Trial Registration: NCT03460652 (ClinicalTrials.gov).