Effect of Aptensio XR (Methylphenidate HCl Extended-Release) Capsules on Sleep in Children with
Judith Owens1, Margaret Weiss2, Earl Nordbrock3
11 Boston Children's Hospital , Harvard Medical School, Boston, Massachusetts.
Insights
Methylphenidate extended-release (MPH-MLR) showed minimal negative sleep impact in children with ADHD during short-term trials. Optimized MPH-MLR doses led to improvements in some sleep measures during longer treatment periods.
Area of Science:
- Pediatric Psychiatry
- Pharmacology
- Sleep Medicine
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Methylphenidate is a widely used stimulant medication for ADHD treatment.
- Extended-release formulations aim to provide sustained symptom control and potentially improve adherence.
Purpose of the Study:
- To investigate the effects of multilayer bead extended-release methylphenidate (MPH-MLR) on sleep patterns in children with ADHD.
- To evaluate sleep as an exploratory endpoint in two pivotal clinical trials.
Main Methods:
- Two studies (N=26 and N=230) involving children with ADHD were conducted.
- Sleep was assessed using the Children's or Adolescent Sleep Habits Questionnaire (CSHQ/ASHQ) during double-blind (DB) and open-label (OL) phases.
- Statistical analyses included analysis of variance, analysis of covariance, and paired t-tests.
Main Results:
- During the brief DB phase, MPH-MLR had minimal negative impact on sleep, with one study showing a placebo effect on sleep onset delay.
- In the longer OL phase, several CSHQ/ASHQ subscales related to sleep improved significantly with optimized MPH-MLR doses in Study 2.
- No significant differences were found between MPH-MLR treatments and placebo in Study 2's DB phase for most sleep parameters.
Conclusions:
- MPH-MLR demonstrated a favorable sleep profile in children with ADHD, with minimal adverse effects during short-term use.
- Optimized MPH-MLR treatment was associated with improvements in specific sleep measures over longer treatment durations.
- Sleep measures were generally not negatively impacted by MPH-MLR, suggesting a manageable safety profile regarding sleep.
Objective:
To evaluate measures of sleep (exploratory endpoints) in two pivotal studies of a multilayer bead extended-release methylphenidate (MPH-MLR) treatment of attention-deficit/hyperactivity disorder in children.
Methods:
Study 1 evaluated the time course of response to MPH-MLR (n = 26) patients in an analog classroom setting through four phases: screening (≤28 days), open label (OL) dose optimization (4 weeks), double-blind (DB) crossover (2 weeks; placebo vs. optimized dose), and follow-up call. Study 2 was a forced-dose parallel evaluation of MPH-MLR (n = 230) in four phases: screening (≤28 days), DB (1 week; placebo or MPH-MLR 10, 15, 20, or 40 mg/day), OL dose optimization (11 weeks), and follow-up call. Sleep was evaluated by parents using the Children's or Adolescent Sleep Habits Questionnaire (CSHQ or ASHQ) during the DB and OL phases. DB analysis: Study 1 (crossover), analysis of variance; Study 2, analysis of covariance. OL analysis: paired t-test.
Results:
DB: treatments were significantly different in Study 1 only for CSHQ Sleep Onset Delay (MPH-MLR, 1.90 vs. placebo, 1.34; p = 0.0046, placebo was better), and Study 2 for CSHQ Parasomnias (treatment, p = 0.0295), but no MPH-MLR treatment was different from placebo (pairwise MPH-MLR treatment to placebo, all p ≥ 0.170). OL: CSHQ total and Bedtime Resistance, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, and Sleep-disordered Breathing subscales decreased (improved, Study 1) significant only for CSHQ Night Wakings (p < 0.05); in Study 2 CSHQ total and Bedtime Resistance, Sleep Duration, Night Wakings, Parasomnias, and Daytime Sleepiness, and ASHQ total, Bedtime, Sleep Behavior, and Morning Waking all significantly improved (p < 0.05).
Conclusions:
In both studies, there was minimal negative impact of MPH-MLR on sleep during the brief DB phase and none during the longer duration OL phase. Some measures of sleep improved with optimized MPH-MLR dose.
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