1 Children's Specialized Hospital, Toms River, NJ, USA.
2 Rutgers Robert Wood Johnson Medical School, Piscataway, NJ, USA.
J Atten Disord. 2018 Jan;22(1):14-24. doi: 10.1177/1087054714554932. Epub 2014 Nov 6.
To evaluate children with ADHD and sleep problems with polysomnography (PSG) after guanfacine extended-release (GXR) administration.
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.
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%).
Morning-administered GXR resulted in decreased sleep and may contribute to sedation.
评估胍法辛缓释剂(GXR)治疗后伴有睡眠问题的注意缺陷多动障碍(ADHD)儿童的多导睡眠图(PSG)结果。
本双盲、随机、安慰剂对照研究因治疗中出现的问题而提前终止,共纳入 29 名 6 至 12 岁的儿童。经过>4 周的剂量调整和>1 周的剂量稳定后,11 名儿童接受了 GXR 治疗,16 名对照者进行了 PSG 分析。
尽管 GXR 改善了 ADHD 症状(主要结局变量),但总睡眠时间却比安慰剂组短(-57.32,SD=89.17 与+31.32,SD=59.54 分钟,p=0.005)。睡眠后觉醒时间每增加 1 小时是导致总睡眠时间减少的主要因素。虽然快速眼动(REM)、非快速眼动(NREM)和 N3/慢波睡眠时间减少,但与整体睡眠时间减少成比例。GXR 治疗常见镇静作用(73%比 6%)。
GXR 早晨给药导致睡眠减少,并可能导致镇静作用。