Post Hoc Analyses of the Effects of Baseline Sleep Quality on SHP465 Mixed Amphetamine Salts Extended-Release Treatment Response in Adults With ADHD

Background: Sleep problems are common in adults with attention-deficit/hyperactivity disorder (ADHD). This study examined the effect of baseline sleep quality on response to treatment with SHP465 mixed amphetamine salts (MAS) extended-release.

Methods: Adults (aged 18–55 years) with DSM-IV-TR–defined ADHD and baseline ADHD-Rating Scale-IV (ADHD-RS-IV) total score ≥24 were randomized to SHP465 MAS (12.5–75 mg) or placebo in a 7-week, double-blind, dose-optimization study. Post hoc analyses evaluated the effects of baseline sleep quality, measured using Pittsburgh Sleep Quality Index (PSQI) component scores, on ADHD-RS-IV score changes from baseline to endpoint and on Brown Attention-Deficit Disorder Scale (BADDS) score changes from baseline to week 7/early termination in participants with (PSQI component scores 2 or 3) and without (PSQI component scores 0 or 1) impaired sleep quality. Analyses were conducted in the intent-to-treat population (placebo, n=132; SHP465, n=136).

Results: Least squares mean treatment differences (95% CI) nominally favored SHP465 MAS over placebo in both sleep impairment groups for ADHD-RS-IV total score changes (all nominal P<0.05), except for sleep efficiency in the impaired group (–4.1 [–11.6, 3.3]; P=0.2696), and BADDS total score changes (all nominal P<0.01), except for sleep duration (–13.0 [–30.3, 4.2]; P=0.1332) and sleep efficiency (1.6 [–13.5, 16.8]; P=0.8226) in the impaired group.

Conclusions: Improvements in ADHD symptoms and executive function occurred with dose-optimized SHP465 MAS regardless of baseline impairment in sleep quality in adults with ADHD, but the magnitude of the treatment effect differed for some assessments as a function of sleep impairment.