Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder.

Sleep disturbances are common among children and adolescents with attention deficit hyperactivity disorder. This study sought to evaluate the effects of individualizing wear times of the methylphenidate transdermal system on sleep parameters. In this open-label, randomized trial, 26 children with attention deficit hyperactivity disorder and sleep disturbances were randomized (after dose optimization) to one of four groups with different sequences of patch wear times (i.e., 9, 10, 11, and 12 hours per day wear times each for week in different sequences). The primary endpoint comprised sleep latency. Secondary endpoints included total sleep time, sleep quality, and attention deficit hyperactivity disorder and related signs (assessed with Attention Deficit Hyperactivity Disorder Rating Scale-IV and Connor's Global Impression-Parent). A mixed-effects regression model evaluated the effects of patch wear time on sleep and symptom measures. Patch wear time exerted no significant effect on sleep latency or total sleep time, although a trend toward improved sleep quality was evident (P = 0.059) with longer patch wear times. Sleep parameters were not adversely affected by longer methylphenidate transdermal system patch wear times. Thus, if replicated in larger samples, the individualization of patch wear times should be considered according to the needs and responses of patients.