- Hsu W-Y, et al. Effects of Melatonin on Sleep Disturbances in Multiple Sclerosis: A Pilot Study. P881, ECTRIMS 2021 Virtual Congress, 13-15 October
- Clark CM, et al. Arch Neurol. 1992;49:641-642
A randomised double-blind controlled pilot trial (NCT04035889) demonstrated patient benefits of melatonin in MS patients. Sleep disturbances and fatigue may be alleviated by this low-cost, low-risk, over-the-counter supplement1. Larger studies need to confirm the results of this pilot study.
Patients with MS often suffer from sleep disturbances2. However, therapeutic options targeting sleep disturbances in these patients are scarce. Therefore, the current pilot trial examined the effect of exogenous melatonin on sleep quality and sleep disturbances in MS patients. Patients with MS and confirmed sleep disturbances (n=30) were randomised 1:1 to a dose-escalating regimen of melatonin (0.5 to 3mg, oral, once daily) or placebo for 2 weeks.
Patients followed the opposite regimen from weeks 2 to 4. Sleep time and sleep efficiency were measured with an actigraphy device. Furthermore, several sleep-related patient-reported outcomes (PROs) were recorded. Mr. Wan-Yu Hsu (University of California, CA, USA) set out the findings of this pilot study. The total sleep time was significantly longer in melatonin receivers (mean 6.96 hours) compared with placebo receivers (mean 6.67 hours, P=0.03).
Moreover, sleep efficiency was numerically higher in melatonin users (84.7%) versus placebo users (83.2%). Mean improvements on the Insomnia Severity Index (ISI) (melatonin -3.5 vs placebo -2.4), the sleep quality component of the Pittsburgh Sleep Quality Index (PSQI) (-.03 vs 0.0), and the Neuro-Quality of life-Fatigue questionnaire (-4.7 vs -2.4) were numerically in favour of melatonin users.