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.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00393042.
authors: Department of Psychiatry, Douglas Mental Health University Institute, McGill University, 6875 LaSalle Boulevard, Verdun, Montreal, QC, H4H 1R3, Canada.
authors: J A
authors: JA
authors: Santisteban
authors: M A
authors: MA
authors: Stein
authors: L
authors: L
authors: Bergmame
authors: R
authors: R
authors: Gruber
mesh_terms: D056044:Actigraphy; D000293:Adolescent; D000662:Amphetamines / Q000008:administration & dosage*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000503:physiopathology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage*; D002648:Child; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D064699:Dexmethylphenidate Hydrochloride / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012492:Salts / Q000008:administration & dosage; D012890:Sleep / Q000187:drug effects* / Q000502:physiology; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000662:Amphetamines; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations; D012492:Salts; D064699:Dexmethylphenidate Hydrochloride