Twice daily treatment with Strattera® (atomoxetine HCl), approved for the treatment of attention-deficit/hyperactivity disorder (ADHD), showed children with ADHD fell asleep faster (12.1 minutes relative to baseline versus 39.2 minutes relative to baseline, p<.001) compared to three-times daily treatment with methylphenidate, according to study results presented at the Associated Professional Sleep Societies meeting.
The results were based on comparisons before treatment and during treatment.
Parent and child diaries also showed that children on Strattera had less difficulty getting out of bed in the morning versus children taking methylphenidate. Additionally, parent diaries showed children on Strattera were less irritable compared to methylphenidate.
"Sleep difficulties related to methylphenidate therapy can represent a considerable source of concern for patients and families of children with ADHD," said study author Judith Owens, M.D., MPH, Child and Family Psychiatry, Rhode Island Hospital, Providence, R.I. "The availability of an effective medication option that may help patients to fall asleep faster is useful in the treatment of ADHD."
Although patients had a greater decrease in the number of wake bouts (episodes of wakening) with methylphenidate (-1.3 for Strattera patients compared to baseline versus -4.4 for methylphenidate patients compared to baseline, p=.011), Strattera allowed patients to sleep longer relative to methylphenidate (-15.3 minutes compared to baseline vs.. -29.6 minutes compared to baseline, p=.016).
A total of 85 children were randomized to a double blind, cross over trial in which participants were treated with Strattera or methylphenidate for seven weeks and then alternated therapy. A portion of three patients' data was removed as they had difficulty utilizing the monitors. After collecting baseline measures, children were treated with Strattera (mean dose 1.56 mg/kg) or methylphenidate (mean dose 1.12 mg/kg) for seven weeks each, separated by a washout period. Relative to baseline, the data indicated that methylphenidate increased time to sleep onset significantly more than Strattera -12.1 minutes for Strattera vs.. 39.2 minutes for methylphenidate, p<.001. For children and adolescents, maximum approved label dosing for Strattera is 1.4 mg/kg/day or 100 mg, whichever is less.
"When kids get the sleep they need, they may be less irritable. This may impact a variety of settings - at home, at school, and in social situations," said A.J. Allen, M.D., Ph.D., Lilly Research Laboratories, Eli Lilly and Company.