Children with attention-deficit hyperactivity disorder (ADHD) and treated with the ADHD medication Azstarys had statistically significant and lasting improvements in their sleep, according to a study published in Frontiers in Psychiatry.

Azstarys (serdexmethylphenidate and dexmethylphenidate), by biopharmaceutical company Corium, was approved by the US Food and Drug Administration in 2021 for the treatment of ADHD symptoms in people aged 6 and older. 

In the yearlong open-label safety study, investigators used the validated Children’s Sleep Habits Questionnaire to evaluate sleep, a pre-specified secondary trial endpoint, in 238 children aged 6 to 12 who received Azstarys. The Children’s Sleep Habits Questionnaire uses 33 questions for caregivers about a child’s sleep behavior across eight domains using a three-point scale of “usually,” “sometimes,” and “rarely.” The eight sleep behaviors are bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. 

Total Children’s Sleep Habits Questionnaire scores can range from 33 to 99, with any score of 41 or higher indicating a sleep disorder. At the study start, all but two children had total scores in the range of 42 to 79, and those two participants scored 37 and 40.

In the yearlong study, after screening and a three-week dose optimization for the new participants, the children received once-daily Azstarys doses of 26.1/5.2 milligrams, 39.2/7.8 milligrams, or 52.3/10.4 milligrams.

After one month of Azstarys treatment, the children’s average total sleep disturbance score significantly decreased, indicating improved sleep. Specifically, their scores declined from 53.4 to 50.5, a reduction of 2.9 points. Moreover, after 12 months of treatment, their average total score remained in the 48.9 to 50.1 range, indicating the children sustained overall sleep improvements while receiving Azstarys.

Almost three in four children with ADHD have some sleep impairment, according to Children and Adults with Attention-Deficit/Hyperactivity Disorder, a national nonprofit organization serving people affected by ADHD. They commonly have trouble falling asleep and staying asleep. Some stimulant medications used to treat ADHD also can disrupt sleep and may cause insomnia.

“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,” says Greg W. Mattingly, MD, lead author, associate clinical professor of psychiatry at Washington University School of Medicine, and president-elect of the American Professional Society for ADHD and Related Disorders, in a release.

Azstarys is the first and only medicine for ADHD symptoms that contains serdexmethylphenidate, the prodrug of dexmethylphenidate, along with immediate-release dexmethylphenidate. Serdexmethylphenidate is a prodrug that is pharmacologically inactive until reaching a patient’s lower gastrointestinal tract where, by design, it gradually converts to dexmethylphenidate throughout the day. This formulation provides rapid control of ADHD symptoms with the immediate-release dexmethylphenidate and extended duration of control with the serdexmethylphenidate. 

“Publication of this encouraging sleep data on Azstarys reinforces why Azstarys is an important treatment option for providing clinically meaningful ADHD symptom control,” says Charles Oh, MD, chief medical officer of Corium, in a release. “Our continued examination of the safety and efficacy of Azstarys is an example of Corium’s strong commitment to deliver innovative solutions that transform care for patients with CNS disorders.”

Azstarys is a Schedule II controlled substance because it contains 30% immediate-release dexmethylphenidate. The serdexmethylphenidate component of Azstarys is a Schedule IV controlled substance.

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