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Pharmacokinetics of exogenous melatonin in relation to formulation, and effects on sleep: A systematic review.

Sleep medicine reviews
June 1, 2021
Irene Moroni et al. (6 authors)
Journal ArticleResearch Support, Non-U.S. Gov'tReviewSystematic ReviewHuman Study
Study Details

Study Goal

The researchers aimed to understand the relationship between different melatonin formulations and their pharmacokinetic properties, and their effects on sleep outcomes.

Results Summary

Six out of seven studies investigating melatonin's effect on sleep found significant improvements in one or more sleep parameters. The abstract suggests potential for improved controlled-release formulations to enhance efficacy.

Population

Not specified in the abstract.

Effective Dosage

Not specified in the abstract.

Duration

Not specified in the abstract.

Interactions

None mentioned

Extracted Claims (7)
InterventionDirectionEndpointPopulationDosageImpactClaim #
melatonin transdermal formulation
neutral
-
-
-
-
#1
melatonin oral formulations
neutral
-
-
-
-
#2
melatonin topical formulation
neutral
-
-
-
-
#3
melatonin buccal formulations
neutral
-
-
-
-
#4
melatonin intravenous formulations
neutral
-
-
-
-
#5
melatonin nasogastric formulations
neutral
-
-
-
-
#6
melatonin formulation
increase
one or more sleep parameters
-
-
found a significant improvement
#7
Abstract

There is conflicting evidence on the clinical efficacy of exogenous melatonin for the treatment of sleep disorders. This may be due to differences in the pharmacokinetic (PK) properties of melatonin formulations used in clinical trials. The aim of this systematic review was to understand the relationship between melatonin formulations and PK parameters and, where possible, the effects on sleep outcomes. To this purpose, we conducted a systematic review and nineteen papers were included. The studies included three melatonin transdermal formulation, thirteen oral formulations, one topical, two buccal, two intravenous and two nasogastric formulations. Seven studies investigated the effect of the melatonin formulation on sleep and six of them found a significant improvement in one or more sleep parameters. The potential for an improved controlled release formulation that delays maximum concentration (C

Medical Subject Headings (MeSH)
Circadian RhythmHumansMelatoninSleepSleep Wake Disorders
Study Links
Quality Scores
SafetyNot Assessed
Efficacy70/10
Quality80/10
Citation Metrics
Total Citations18
Citations/Year4.5
Relative Citation Ratio1.82
NIH Percentile71.5%
Research Impact Scores
APT Score0.75
Weight Score2.58
Normalized Score0.64
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