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. 2021 Nov 14;11(11):1204. doi: 10.3390/jpm11111204

Table 3.

Studies describing effects of melatonin analogues in patients with RBD.

Authors, Year [Ref] Study Setting/Design Type of Study Main Findings Level of Evidence (Quality Score)
Bonakis et al., 2012 [45] 3 patients with iRBD treated with agomelatine (MT1 and MT2 melatonin receptor agonist and a 5-HT2 antagonist) 25–50 mg 1 h before bedtime Case report series

  • Significant improvement in 1 patient and partial improvement in 2 patients with 25 mg (these patients considerably improved with increasing dose to 50 mg)

  • A trend for improvement in sleep efficiency with decreased WASO, a slight increase in the percentage of REM epochs with muscle atonia, and a decrease in 2 patients of the percentage of REM epochs with high tonic density

  • No adverse effects were reported.

 III (NA)
Nomura et al., 2013 [46] The first description of 2 patients with PD and MSA treated with ramelteon (MT1 and MT2 melatonin receptor agonist) Case report series

  • Improvement of clinical RBD symptoms

  • Significant decrease in the percentage of REM sleep without atonia by PSG

 III (NA)
Kashihara et al., 2016 [47] 35 patients diagnosed with idiopathic PD accompanied by sleep disturbances (24 of them with probable RBD) treated with 8 mg of ramelteon before sleep A 12-week multicentre open-label trial

  • Significant improvement in RBDQ-JP, UPDRS Part III, and PDSS-2 scores

 II (NA)
Esaki et al., 2016 [48] 12 patients with RBD treated with 8 mg of ramelteon 30 min before bedtime 4-week open-label trial

  • A non-significant trend toward clinical improvement in a visual analogue scale in some cases.

  • Lack of significant effect on REM sleep without atonia or in an RBD severity scale measured by video-supported PSG.

 II (NA)

5-HT, 5-hydroxytryptamine (serotonin); iRBD, idiopathic or isolated REM sleep behaviour disorder; MSA, multisystem atrophy; MT, melatonin; PD, Parkinson’s disease; PDSS-2, Parkinson’s disease Sleep Scale-2; PSG, polysomnography; RBD, REM sleep behaviour disorder; RBDQ-KR, RBD Questionnaire-Korean version; RBDQ-JP, RBD Questionnaire Japanese version; RBDSS, RBD severity score, REM, rapid eye movements; UPDRS, Unified Parkinson’s Disease Rating Scale; WASO, wake after sleep onset.