Effect of lisdexamfetamine dimesylate on sleep in children with ADHD.
OBJECTIVE
This study evaluated the potential effects of short-term treatment with lisdexamfetamine dimesylate (LDX) on both subjective and objective sleep characteristics in children aged 6 to 12 years (n = 24) with ADHD.


METHODS
Polysomnography (PSG) and actigraph measures as well as assessments of subjective sleep parameters were examined in children before and after treatment with either LDX or placebo in a randomized, double-blind, single-center, parallel-group study.


RESULTS
There was no statistically significant increase in the primary endpoint of latency to persistent sleep (LPS) for the LDX-treated group compared to the placebo group. Secondary PSG or actigraph results generally supported primary endpoint results. Subjective sleep measure results indicated the possibility that responses are influenced by sleep hygiene counseling before and throughout the study.


CONCLUSIONS
In this pilot sleep study in children with ADHD, LDX did not appear to contribute to any sleep disturbances as measured by both objective and subjective sleep parameters. The sample used in this study was small, and the multifarious nature of findings in this study warranted that the study conclusions be interpreted cautiously and that further study is required focusing on the influence of LDX on sleep in larger samples of ADHD children.
Giblin
John M
JM
Clinical Study Centers LLC, Little Rock, AR, USA. giblinmd@clinstudy.com
Strobel
Aaron L
AL
D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000494:pharmacology* / Q000627:therapeutic use; D002648:Child; D003913:Dextroamphetamine / Q000494:pharmacology* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D017286:Polysomnography; D012890:Sleep / Q000187:drug effects*; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine