Effect of lisdexamfetamine dimesylate on sleep in adults with attention-deficit/hyperactivity disorder

Lenard A Adler,Thomas Roth,Mohamed Hamdani,David Goodman,Richard Weisler

doi:10.1186/1744-9081-5-34

Abstract

BackgroundSleep 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.MethodsThis 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).ResultsThe 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.ConclusionFor most subjects, LDX was not associated with an overall worsening of sleep quality and significantly improved daytime functioning in adults with ADHD.Trial Registrationclinicaltrials.gov Identifier: NCT00334880

Highlights

Sleep problems are common in adults with attention-deficit/hyperactivity disorder (ADHD)
lisdexamfetamine dimesylate (LDX) was not associated with an overall worsening of self-reported sleep quality
In this population of adults with ADHD, sleep quality at baseline, as assessed by the Pittsburgh Sleep Quality Index (PSQI), was generally poor. In those subjects who reported sleep-related treatment-emergent AEs (TEAEs), PSQI scores were no different from placebo

Summary

Introduction

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. Attention deficit/hyperactivity disorder (ADHD), characterized by a pattern of inattention and/or hyperactivity, is one of the most prevalent psychiatric disorders worldwide [1]. Subjective reports of sleep problems are frequent among both adult and pediatric patients with ADHD [8,9]. Anatomical and functional regions of the central nervous system responsible for ADHD symptoms and those involved in sleep regulation seemingly overlap [10]. Patient reports of disturbed sleep are significantly associated with their current ADHD symptom severity. A study by Kass et al demonstrated that daytime sleepiness and insomnia were predictors of increased ADHD symptomatology as assessed by the Adult Behavior Checklist in young adults [11]

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Results

Discussion

Conclusion