Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Mar 7;6(4):716-722.
doi: 10.1002/acn3.753. eCollection 2019 Apr.

Prolonged-release melatonin in patients with idiopathic REM sleep behavior disorder

Jin-Sun Jun  1   2 , Ryul Kim  1 , Jung-Ick Byun  3 , Tae-Joon Kim  4 , Jung-Ah Lim  5 , Jun-Sang Sunwoo  6 , Soon-Tae Lee  1 , Keun-Hwa Jung  1 , Kyung-Il Park  7 , Kon Chu  1 , Manho Kim  1 , Sang Kun Lee  1 , Ki-Young Jung  1
Affiliations

Prolonged-release melatonin in patients with idiopathic REM sleep behavior disorder

Jin-Sun Jun et al. Ann Clin Transl Neurol. .

Erratum in

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.

PubMed Disclaimer

Conflict of interest statement

No conflicting relationship exists for the authors.

Figures

Figure 1
Figure 1
A flow chart illustrating the study process. PRM, prolonged‐release melatonin.
Figure 2
Figure 2
Proportion of patients for each Clinical Global Impression‐Improvement score at the 4‐week follow‐up. PRM, prolonged‐release melatonin.
Figure 3
Figure 3
Changes in the Korean version of the REM sleep behavior disorder questionnaire‐Hong Kong (RBDQ‐KR) score at baseline and the 4‐week follow‐up. PRM, prolonged‐release melatonin.
See this image and copyright information in PMC

References

    1. Schenck CH, Bundlie SR, Mahowald MW. Chronic behavioral disorders of human REM sleep: a new category of parasomnia. Sleep 1986;9:293–308. - PubMed
    1. Högl B, Stefani A, Videnovic A. Idiopathic REM sleep behaviour disorder and neurodegeneration ‐ an update. Nat Rev Neurol 2018;14:40–55. - PubMed
    1. Schenck CH, Boeve BF, Mahowald MW. Delayed emergence of a parkinsonian disorder or dementia in 81% of older men initially diagnosed with idiopathic rapid eye movement sleep behavior disorder: a 16‐year update on a previously reported series. Sleep Med 2013;14:744–748. - PubMed
    1. Iranzo A, Tolosa E, Gelpi E, et al. Neurodegenerative disease status and post‐mortem pathology in idiopathic rapid‐eye‐movement sleep behaviour disorder: an observational cohort study. Lancet Neurol 2013;12:443–453. - PubMed
    1. Schenck CH, Hurwitz TD, Mahowald MW. Symposium: normal and abnormal REM sleep regulation: REM sleep behaviour disorder: an update on a series of 96 patients and a review of the world literature. J Sleep Res 1993;2:224–231. - PubMed

LinkOut - more resources