Department of Psychiatry and Child and Adolescent Psychiatry, New York University School of Medicine, NY, USA.
Behav Brain Funct. 2009 Aug 3;5:34. doi: 10.1186/1744-9081-5-34.
Sleep problems are common in adults with attention-deficit/hyperactivity disorder (ADHD). This analysis aimed to evaluate the impact of lisdexamfetamine dimesylate (LDX) on sleep quality in adults with ADHD.
This 4-week, phase 3, double-blind, forced-dose escalation study of adults aged 18 to 55 years with ADHD randomized participants to receive placebo (n = 62), or 30 (n = 119), 50 (n = 117), or 70 (n = 122) mg/d LDX, taken once a day in the morning. The self-rated Pittsburgh Sleep Quality Index (PSQI) was administered at baseline and at week 4 to assess sleep quality. The PSQI global score assesses 7 sleep components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction) each scored from 0 (no difficulty) to 3 (severe difficulty).
The mean baseline PSQI global score was 5.8 for LDX and 6.3 for placebo (P = .19) indicating poor overall sleep quality. At endpoint, least squares (LS) mean change from baseline was -0.8 for LDX vs -0.5 for placebo (P = .33). The daytime functioning component showed significant improvement in LS mean change at endpoint for LDX compared with placebo (LDX -0.4 vs placebo 0.0, P = .0001). LS mean changes for the other 6 PSQI components did not significantly differ from placebo. Sleep-related treatment-emergent adverse events with an incidence >/=2% in the active treatment and placebo groups, respectively, were insomnia (19.3% and 4.8%), initial insomnia (5.0% and 3.2%), middle insomnia (3.6% and 0%), sleep disorder (0.6% and 3.2%), somnolence (0.3% and 3.2%), and fatigue (4.7% and 4.8%), and were generally mild or moderate in severity.
For most subjects, LDX was not associated with an overall worsening of sleep quality and significantly improved daytime functioning in adults with ADHD.
clinicaltrials.gov Identifier: NCT00334880.
睡眠问题在患有注意缺陷多动障碍（ADHD）的成年人中很常见。本分析旨在评估二甲磺酸赖右苯丙胺（LDX）对 ADHD 成年人睡眠质量的影响。
这是一项为期 4 周、3 期、双盲、强制剂量递增的研究，纳入了年龄在 18 至 55 岁的 ADHD 成年患者，将患者随机分为安慰剂组（n = 62）、30 mg/d（n = 119）、50 mg/d（n = 117）或 70 mg/d（n = 122）LDX 组，每天早上 1 次给药。使用匹兹堡睡眠质量指数（PSQI）自评分在基线和第 4 周评估睡眠质量。PSQI 总分评估 7 个睡眠成分（主观睡眠质量、睡眠潜伏期、睡眠持续时间、习惯性睡眠效率、睡眠障碍、使用助眠药物和白天功能障碍），每项评分范围为 0（无困难）至 3（严重困难）。
LDX 的平均基线 PSQI 总分和安慰剂组分别为 5.8 和 6.3（P =.19），表明整体睡眠质量较差。在终点时，LDX 从基线的最小二乘（LS）均值变化为-0.8，而安慰剂为-0.5（P =.33）。与安慰剂相比，LDX 组在白天功能成分的 LS 均值变化在终点时具有显著改善（LDX-0.4 对安慰剂 0.0，P =.0001）。其他 6 个 PSQI 成分的 LS 均值变化与安慰剂相比无显著差异。在活跃治疗和安慰剂组中发生率分别大于等于 2%的与治疗相关的不良事件有失眠（19.3%和 4.8%）、初始失眠（5.0%和 3.2%）、中段失眠（3.6%和 0%）、睡眠障碍（0.6%和 3.2%）、思睡（0.3%和 3.2%）和疲劳（4.7%和 4.8%），通常为轻度或中度。
对于大多数患者来说，LDX 并不会导致睡眠质量整体恶化，并显著改善 ADHD 成年人的白天功能。
clinicaltrials.gov 标识符：NCT00334880。
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