Serdexmethylphenidate/Dexmethylphenidate Effects on Sleep in Children With Attention-Deficit Hyperactivity Disorder

Abstract: Aim: To determine sleep behavior during serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) treatment in children with attention-deficit hyperactivity disorder (ADHD). Methods: This was a 12-month, dose-optimized, open-label safety study in 6–12-year-old subjects, including new subjects and those rolled over from a previous double-blind study (J Child Adolesc Psychopharmacol. 2021;31:597). The primary endpoint was safety and tolerability of SDX/d-MPH. A secondary endpoint was sleep behavior based on the Children’s Sleep Habits Questionnaire (CSHQ) consisting of 8 sleep domains (bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness). Results: Of 282 subjects enrolled (212, new; 70 rolled over), 238 were included in the sleep analysis. At baseline, mean (SD) CSHQ total sleep disturbance score was 53.4 (5.9). After 1 month of treatment, the overall mean CSHQ score significantly decreased to 50.5 (5.4; least-squares mean change from baseline [95% CI], −2.9 [−3.5, −2.4]; PShort Description: This study's aim was to determine sleep behavior during serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) treatment in children with attention-deficit hyperactivity disorder. Analysis of the secondary end point of sleep behavior based on the Children’s Sleep Habits Questionnaire (CSHQ) of a 12-month, dose-optimized, open-label safety study showed statistically significant improvements in most CSHQ sleep domains with SDX/d-MPH use after 1 month and lasting up to 12 months of treatment. The use of SDX/d-MPH did not worsen sleep problems.Name of Sponsoring Organization(s): Corium, Inc.