Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder.

TitleEffect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder.
Publication TypeJournal Article
Year of Publication2014
AuthorsSantisteban JA, Stein MA, Bergmame L, Gruber R
JournalCNS Drugs
Volume28
Issue9
Pagination825-33
Date Published2014 Sep
ISSN1172-7047
KeywordsActigraphy, Adolescent, Amphetamines, Attention Deficit Disorder with Hyperactivity, Central Nervous System Stimulants, Child, Cross-Over Studies, Delayed-Action Preparations, Dexmethylphenidate Hydrochloride, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Salts, Sleep, Surveys and Questionnaires, Time Factors, Treatment Outcome
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.

DOI10.1007/s40263-014-0181-3
Alternate JournalCNS Drugs
PubMed ID25056567
PubMed Central IDPMC4362706
Grant ListKL2 RR029878 / RR / NCRR NIH HHS / United States
UL1RR029879 / RR / NCRR NIH HHS / United States

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