Prolonged–release melatonin in patients with idiopathic REM sleep behavior disorder. Issue 4 (7th March 2019)

• Record Type: Journal Article
• Authors: Jun, Jin‐Sun; Kim, Ryul; Byun, Jung‐Ick; Kim, Tae‐Joon; Lim, Jung‐Ah; Sunwoo, Jun‐Sang; Lee, Soon‐Tae; Jung, Keun‐Hwa; Park, Kyung‐Il; Chu, Kon; Kim, Manho; Lee, Sang Kun; Jung, Ki‐Young
• Is Part Of: Annals of clinical and translational neurology. Volume 6:Issue 4(2019)
• Page Start: 716
• Page End: 722
• Publication Date: 2019-03-07
• Subjects: Nervous system -- Diseases -- Periodicals; Neurology -- Periodicals; 616.8005
• DOI: 10.1002/acn3.753
• Languages: English
• ISSNs: 2328-9503

Abstract

Abstract: Objective: We investigated the effects of prolonged‐release melatonin (PRM) on idiopathic rapid eye movement (REM) sleep behavior disorder (iRBD). Methods: In this 4‐week, randomized, double–blind, placebo–controlled pilot study, 30 participants with polysomnography–confirmed iRBD were assigned to receive PRM 2 mg per day, PRM 6 mg per day, or placebo. Medication was administered orally 30 min before bedtime. Primary outcomes included scores from the Clinical Global Impression‐Improvement (CGI‐I) and the Korean version of the RBD questionnaire‐Hong Kong (RBDQ‐KR). The secondary outcomes included RBDQ‐KR factor 1 and factor 2 subscores, the Pittsburgh Sleep Quality Index score, the Epworth Sleepiness Scale score, the Short Form Health Survey version 2 score, and the frequency of dream–enacting behaviors assessed using a sleep diary. Results: After 4 weeks, there were no differences in the proportions of patients with a CGI‐I score of much improved or very much improved among the study groups. In addition, RBDQ‐KR scores and secondary outcomes were not improved in all groups at 4 weeks, and there were no differences between the groups. Conclusion: Our findings suggest that PRM may not be effective in treating RBD–related symptoms within the dose range used in this study. Further studies using doses higher than 6 mg per day are warranted.