Effect on Primary Sleep Disorders When Children With ADHD Are Administered Guanfacine Extended Release.
OBJECTIVE
To evaluate children with ADHD and sleep problems with polysomnography (PSG) after guanfacine extended-release (GXR) administration.


METHODS
Double-blind, randomized, placebo-controlled study was terminated early due to treatment-emergent concerns after enrolling 29 children aged 6 to 12 years. After >4 weeks dose adjustment and >1 week dose stabilization, 11 children received GXR and 16 controls underwent analyses with PSG.


RESULTS
Although GXR improved ADHD symptoms, the primary outcome variable, total sleep time, was shorter in contrast to placebo (-57.32, SD = 89.17 vs. +31.32, SD = 59.54 min, p = .005). Increased time awake after sleep onset per hour of sleep was the primary factor for the reduction. Although rapid eye movement (REM), non-REM, and N3/slow wave sleep times were reduced, these were proportional to the overall sleep reduction. Sedation was common with GXR (73% vs. 6%).


CONCLUSIONS
Morning-administered GXR resulted in decreased sleep and may contribute to sedation.
1 Children's Specialized Hospital, Toms River, NJ, USA.|2 Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA.
Thomas A
TA
Rugino
D000293:Adolescent; D058647:Adrenergic alpha-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000150:complications / Q000188:drug therapy*; D002648:Child; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials; D005260:Female; D016316:Guanfacine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D017286:Polysomnography; D011569:Psychiatric Status Rating Scales; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy / Q000523:psychology
D058647:Adrenergic alpha-2 Receptor Agonists; D003692:Delayed-Action Preparations; D016316:Guanfacine
ADHD; insomnia; pharmacotherapy; polysomnography; randomized controlled trial; sleep