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01-09-2014 | Original Research Article

Effect of Extended-Release Dexmethylphenidate and Mixed Amphetamine Salts on Sleep: A Double-Blind, Randomized, Crossover Study in Youth with Attention-Deficit Hyperactivity Disorder

Authors: J. A. Santisteban, M. A. Stein, L. Bergmame, R. Gruber

Published in: CNS Drugs | Issue 9/2014

Abstract

Objective

We sought to determine the dose-response effects of extended-release (ER) dexmethylphenidate (d-MPH) and ER mixed amphetamine salts (MAS) on objective measures of sleep.

Methods

This was an 8-week, double-blind, placebo-controlled, randomized, two period, crossover study of youth with attention-deficit hyperactivity disorder (ADHD) as confirmed by the Kiddie Schedule for Affective Disorders for School-Age Children–Present and Lifetime version (K-SADS-PL). Children aged 10–17 years were recruited from clinical practice, colleague referrals, and flyers. Participants were randomized to initially receive either d-MPH or MAS. During each 4-week drug period, children received three dose levels (10, 20, and 25/30 mg) in ascending order, with placebo substituted for active medication in a randomized fashion during 1 week of the study. After 4 weeks, participants were switched to the alternative medication for another 4 weeks of treatment. The main outcome measure was sleep duration as measured by actigraphy. Children, parents, and researchers were blinded to drug, dose, and placebo status.

Results

Sixty-five participants met the inclusion criteria and were enrolled in the study. Of these, 37 participants with sufficient sleep data for analysis were included. Sleep schedule measures showed a significant effect for dose on sleep start time (F(1,36) = 6.284; p < 0.05), with a significantly later sleep start time when children were receiving 20- or 30-mg doses, compared with placebo (p < 0.05). A significant dose effect was found on actual sleep duration (F(1,36) = 8.112; p < 0.05), with significantly shorter actual sleep duration for subjects receiving 30 mg compared with those receiving placebo (p < 0.05). There were no significant differences on sleep duration or sleep schedule between the two stimulant medications. The trial is complete and closed to follow-up.

Conclusions

Higher stimulant doses were associated with reduced sleep duration and later sleep start times, regardless of medication class.

Trial registration

ClinicalTrials.gov: NCT00393042.

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Title: Effect of Extended-Release Dexmethylphenidate and Mixed Amphetamine Salts on Sleep: A Double-Blind, Randomized, Crossover Study in Youth with Attention-Deficit Hyperactivity Disorder
Authors: J. A. Santisteban
M. A. Stein
L. Bergmame
R. Gruber
Publication date: 01-09-2014
Publisher: Springer International Publishing
Published in: CNS Drugs / Issue 9/2014
Print ISSN: 1172-7047
Electronic ISSN: 1179-1934
DOI: https://doi.org/10.1007/s40263-014-0181-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effect of Extended-Release Dexmethylphenidate and Mixed Amphetamine Salts on Sleep: A Double-Blind, Randomized, Crossover Study in Youth with Attention-Deficit Hyperactivity Disorder

Abstract

Objective

Methods

Results

Conclusions

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Objective

Methods

Results

Conclusions

Trial registration

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