Azstarys improves sleep in children with ADHD, no significant impact on growth

Key Takeaways

• Azstarys improved sleep habits in children with ADHD.
• Differences in expected weight and height were modest and diminished later in treatment.

Azstarys improved sleep habits and did not affect growth rates in children with ADHD, according to two recent studies.

Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH], Corium) is the first ADHD medication that contains SDX, the prodrug of d-MPH, according to a press release from Corium, a biopharmaceutical company. SDX remains pharmacologically inactive until reaching a patient’s lower gastrointestinal tract, where it gradually converts d-MPH, allowing an extended duration of control of ADHD symptoms. Azstarys has a similar adverse events profile to other stimulant treatments.

“Newly published data for Azstarys have reaffirmed the benefits of the treatment for ADHD patients ages 6 years through adulthood,” Ann C. Childress, MD, president of The Center for Psychiatry and Behavioral Medicine in Las Vegas, told Healio in an interview. “Azstarys publications address many of the concerns patients with ADHD commonly have, including sleep problems and slowing of weight and height growth, while delivering the benefit of rapid onset of action, day-long efficacy and proven safety.”

Improved sleep habits

Roughly three in four children with ADHD have some type of sleep impairment, and some stimulant medications used to treat ADHD may exacerbate disturbed sleep, according to a Corium press release on a recent Frontiers in Psychiatry study.

In a year-long, open-label safety study of 238 participants with ADHD aged 6 to 12 years, sleep behavior was assessed using the Children’s Sleep Habits Questionnaire (CSHQ), a caregiver-reported screening survey designed to assess behavioral and medical sleep problems. At baseline, the mean CSHQ total score was 53.4, but after 1 month of treatment, the mean CSHQ total score dropped to 50.5. Mean sleep score improvements remained decreased for up to 12 months of treatment.

Five of the eight sleep domains analyzed saw significant improvement, with the greatest improvements in parasomnias and daytime sleepiness. Sleep onset delay and sleep duration scores both increased from baseline to 12 months, while no significant worsening occurred in sleep duration and sleep-disordered breathing domains. Sleep onset delay was significantly worsened, the researchers wrote.

“Given how common sleep problems are for those with ADHD, the sleep improvements identified in this analysis of the Azstarys long-term safety study are meaningful and relevant safety information about this novel medicine,” study author Greg W. Mattingly, MD, associate clinical professor of psychiatry at Washington University School of Medicine and president-elect of the American Professional Society for ADHD and Related Disorders, said in the press release.

Weight, height growth rates

In a post hoc analysis of dose-optimized phase 3 safety study of 238 subjects aged 6 to 12 years in the Journal of Child and Adolescent Psychopharmacology, Childress and colleagues examined the effects of Azstarys on growth in children over 12 months.

The researchers collected weight and height Z-scores at baseline and predicted the weight and height for each subject based on the United States 2000 CDC Growth charts.

During treatment, the mean weight and height Z-scores were below the expected weight and height, but the changes were not clinically significant, Childress and colleagues wrote. Furthermore, the effects of treatment on weight and height either plateaued or diminished later in treatment.

“This new analysis strengthens the profile of Azstarys as an important treatment option for safe, effective and sustained ADHD symptom control that clinicians, parents and patients should consider,” said Charles Oh, MD, chief medical officer of Corium.

Editor’s note: This article was updated on July 10, 2023, to correct Dr. Childress’ affiliation. Healio regrets the error.

References:

• Mattingly GW, et al. Front Psychiatry. 2023;doi:10.3389/fpsyt.2023.1193455.
• Journal Frontiers in Psychiatry publishes analysis of open label safety study showing improvements in sleep habits for children with ADHD after treatment with Azstarys (serdexmethylphenidate and dexmethylphenidate). https://www.biospace.com/article/releases/journal-frontiers-in-psychiatry-publishes-analysis-of-open-label-safety-study-showing-improvements-in-sleep-habits-for-children-with-adhd-after-treatment-with-azstarys-serdexmethylphenidate-and-dexmethylphenidate-/#:~:text=The%20analysis%20showed%20that%20study%20participants%2C%20children%20aged,and%20medically%20based%20sleep%20problems%20in%20school%20children. Published: June 26, 2023. Accessed: July 3, 2023.
• Corium's novel ADHD medication Azstarys (serdexmethylphenidate and dexmethylphenidate) had no clinically significant impact on children's weight and height growth rate. https://www.prnewswire.com/news-releases/coriums-novel-adhd-medication-azstarys-serdexmethylphenidate-and-dexmethylphenidate-had-no-clinically-significant-impact-on-childrens-weight-and-height-growth-rate-301830739.html. Published: May 22, 2023. Accessed: July 3, 2023.