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09.02.2022 | Neurology • Original Article

Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder

verfasst von: Jung-Ick Byun, Yu Yong Shin, Yoon-Ah Seong, Seon-Min Yoon, Kyoung Jin Hwang, Yu Jin Jung, Kwang Su Cha, Ki-Young Jung, Won Chul Shin

Erschienen in: Sleep and Breathing | Ausgabe 1/2023

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Abstract

Purpose

Clonazepam and melatonin are recommended as first-line treatments for isolated rapid eye movement (REM) sleep behavior disorder (iRBD). This study aimed to compare their efficacy and safety in REM sleep without atonia (RWA) and RBD-related symptoms.

Methods

This prospective, open-label, randomized trial included patients with video-polysomnography-confirmed iRBD. The patients were randomly assigned to receive either clonazepam 0.5 mg or prolonged-release (PR) melatonin 2 mg 30 min before bedtime for 4 weeks. The primary outcome was changes in RWA on follow-up polysomnography (PSG). Secondary endpoints were changes in other PSG parameters, clinical global improvement-impression scale (CGI-I) scores, and sleep questionnaire scores. The safety endpoint was adverse events.

Results

Of 40 patients with probable RBD considered, 34 were enrolled in the study and randomized. Visual scoring parameters of RWA indices were reduced, and automatic scoring parameters tended to be improved after clonazepam treatment but not after PR melatonin treatment. The proportion of N2 sleep was increased, and N3 and REM sleep were decreased only in the clonazepam group. The clonazepam group tended to answer “much or very much improvement” on the CGI-I more frequently than the PR melatonin group (p = 0.068). Daytime sleepiness and insomnia symptoms were reduced after PR melatonin but not after clonazepam. Depressive symptoms increased after clonazepam. Four of the patients (13.3%) reported mild to moderate adverse events, which were similar between the two groups.

Conclusion

Four weeks of clonazepam, but not PR melatonin, improved RWA. RBD symptom improvement tended to be better after clonazepam than PR melatonin in exchange for increased depressive symptoms and daytime sleepiness.

ClinicalTrials.gov identifier: NCT03255642 (first submitted August 21, 2017)

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Titel: Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder
verfasst von: Jung-Ick Byun
Yu Yong Shin
Yoon-Ah Seong
Seon-Min Yoon
Kyoung Jin Hwang
Yu Jin Jung
Kwang Su Cha
Ki-Young Jung
Won Chul Shin
Publikationsdatum: 09.02.2022
Verlag: Springer International Publishing
Erschienen in: Sleep and Breathing / Ausgabe 1/2023
Print ISSN: 1520-9512
Elektronische ISSN: 1522-1709
DOI: https://doi.org/10.1007/s11325-022-02572-8

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Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder