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Ramelteon for Insomnia Related to Attention-Deficit/Hyperactivity Disorder (ADHD)
Rachel E Fargason1, Karen Gamble1, Kristin T Avis1
1Dr. Fargason, MD, is Director of the Adult ADHD Clinic and an Associate Professor of Psychiatry & Behavioral Neurobiology. Dr. Gamble, PhD, is an Assistant Professor in the Department of Psychiatry & Behavioral Neurobiology. Dr. Avis, PhD, is an Associate Professor in Pediatrics. Ms. Besing, is a Graduate Research Assistant in the Behavioral Neuroscience program in the Psychology Department all at the University of Alabama at Birmingham School of Medicine. Dr. Cherry W. Jackson, PharmD, Professor of Pharmacy, Auburn University, Clinical Professor, Psychiatry and Behavioral Neurobiology, University of Alabama, Birmingham. Dr. Cates, PharmD, is a Professor of Pharmacy Practice at Samford University, McWhorter School of Pharmacy. Ms. May, MA, is an Assistant Professor in the Department of Psychiatry & Behavioral Neurobiology and Director of the Office of Psychiatric Clinical Research.
Objectives:
This study evaluated the efficacy of ramelteon for insomnia in adult subjects with ADHD.
Experimental Design:
For this randomized, double-blind, placebo-controlled crossover trial, 8 mg of ramelteon was given nightly, within three hours of bedtime, to ADHD-insomnia subjects confirmed by DSM-IV-TR, ADHD-RS, MINI, and clinical interview. All subjects underwent two weeks each of ramelteon and placebo. Objective sleep measures were obtained by actigraphy. Subjective measures included: the Epworth Sleepiness Scale (ESS) and ADHD-RS.
Principal Observations:
Of 36 subjects entering the study, 58% met criteria for circadian rhythm sleep disorder (CRSD), delayed sleep phase type. During ramelteon period, mid-sleep time, an indicator of circadian phase, occurred significantly earlier, by ~45 minutes compared to placebo period. An association was noted between the magnitude of the sleep phase advance and the timing of ramelteon administration in relationship to sleep start time, but did not reach statistical significance; maximal efficacy was noted 1.5 hours before bedtime. Paradoxically, ramelteon marginally, but significantly increased sleep fragmentation and ESS scores compared to the placebo state.
Conclusions:
Ramelteon is efficacious in maintaining an earlier sleep/wake cycle in adults with ADHD and CRSD but can have paradoxical fragmenting effects on sleep and exacerbate daytime sleepiness. In the presence of a circadian rhythm disorder, the usual dosing and timing parameters for ramelteon need to be carefully considered.
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