Key Points
• Source: Frontiers in Psychiatry
• Conclusion: “In this analysis of children taking SDX/d-MPH [serdexmethylphenidate/dexmethylphenidate] for ADHD, sleep problems did not worsen based on the mean CSHQ total sleep disturbance score. Statistically significant improvements in most CSHQ sleep domains were observed after 1 month and lasted for up to 12 months of treatment.”
• In the current post hoc analysis, U.S. investigators assessed individual sleep domains based on data from the original 12-month, dose-optimized, open-label safety study consisting of 238 6- to 12-year-old participants. A secondary endpoint was the assessment of sleep behavior using the Children’s Sleep Habits Questionnaire (CSHQ). This tool comprises 8 sleep domains: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness.
• Statistically significant improvements in most CSHQ sleep domains were observed after 1 month, with effects continuing as many as 12 months out. The vast majority of children had preexisting sleep disturbances before the study began (i.e., a CSHQ score > 41).
• “After 12 months of treatment with SDX/d-MPH, noticeably more participants had a lower sleep disturbance score from baseline; however, overall sleep remained in the category of clinical disturbances (overall score > 41). Importantly, these findings show that the use of SDX/d-MPH does not worsen CSHQ total score from baseline,” said the investigators.
• Limitations of the current study include the examination of sleep behavior post hoc (i.e., not as a primary study objective) and that nearly every patient reported preexisting sleep disturbances at baseline, which could interfere the medication effect.