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No Daytime Sleepiness for Children Taking Guanfacine for Attention-Deficit Hyperactivity Disorder: Presented at AACAP By Maria Bishop BOSTON, MA -- October 30, 2007 -- Children taking the nonstimulant guanfacine for attention-deficit hyperactivity disorder (ADHD) are not likely to experience drug-related classroom sleepiness, and may even have a better sleep at night, according to a short-term study presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP). Scott. H. Kollins, PhD, Assistant Professor, Department of Psychiatry, Duke University Medical Center, Durham, North Carolina, United States, led this double-blind, phase 2 study of 178 children aged 6 to 17 years. The study randomised children in a 2:1 ratio to receive guanfacine extended release at a dose of 1 mg/day, 2 mg/day, or 3 mg/day, or to placebo. Overall, 166 of the 178 subjects (93%) completed at least 6 weeks of the treatment. In previous trials, alpha 2-receptor agonists have been associated with sedation, Dr. Kollins explained. However, in this study, there was no evidence of daytime sleepiness in subjects taking guanfacine when measured by the Pediatric Daytime Sleepiness Scale (PDSS). In fact, small decreases in PDSS scores were observed in the guanfacine group, and not in the placebo group at visits 6 and 7 and at endpoint (P <=.05 for each). These findings may indicate that there was reduced daytime sleepiness and increased alertness in the active-treatment group. The Pictorial Sleepiness Scale (PSS) measured both daytime and nighttime sleepiness in subjects. PSS observer classroom assessments indicated that guanfacine did not significantly affect daytime sleepiness in the classroom, and PSS subject assessments were very similar. At-home evening PSS assessments at 10 hours post-dose and 12 hours post-dose showed greater sleepiness in the guanfacine group than in the placebo group. Most adverse events related to guanfacine in this study were mild to moderate in intensity, according to the researchers. Small decreases in systolic/diastolic blood pressure and pulse rate were consistent with the known side effects of guanfacine, they said. Funding for this study was provided by Shire Development Inc. [Presentation title: Guanfacine Extended Release in ADHD: Safety and Sleep Effects: Abstract B48] E-mail this page to a friend or colleague! To print, use this version