Peer-Reviewed Literature

Sleep Optimization Research

Systematic reviews and clinical trials on Sleep Optimization sourced directly from PubMed (NCBI). No marketing language — only what the published science actually shows.

8+ peer-reviewed studies in this area (2010–2025)
Recent systematic reviews & clinical trials
PubMed · 2022
Effect of melatonin supplementation on sleep quality: a systematic review and meta-analysis of randomized controlled trials
Fatemeh G, Sajjad M, Niloufar R et al. · Journal of neurology
[BACKGROUND] The Present study was conducted to systematically review the effect of the melatonin on sleep quality. We summarized evidence from randomized clinical trials (RCTs) that investigated the effects of melatonin on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in adults with various diseases. [METHODS] The literature searches of English publications in MEDLINE and EMBASE databases were performed up June 2020. Results were summarized as mean differences (MD) with 95% confidence intervals (CI) using random effects model (DerSimonian-Laird method). Heterogeneity among studies was evaluated by the Cochrane Q test and I-squared (I2). To determine the predefined sources of heterogeneity, subgroup analysis was performed. [RESULTS] Of 2642 papers, 23 RCTs met inclusion criteria. Our results indicated that melatonin had significant effect on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (WMD: - 1.24; 95% CI - 1.77, - 0.71, p = 0.000). There was significant heterogeneity between studies (I [CONCLUSION] We found that the treatment with exogenous melatonin has positive effects on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in adult. In adults with respiratory diseases, metabolic disorders, primary sleep disorders, not with mental disorders, neurodegenerative diseases and other diseases.
Read on PubMed (PMID 33417003)
PubMed · 2022
Efficacy of dietary supplements on improving sleep quality: a systematic review and meta-analysis
Chan V, Lo K · Postgraduate medical journal
[PURPOSE] Different dietary supplements aimed at improving sleep quality are available on the market, but there has not been a comprehensive review to evaluate the efficacy of these dietary supplements on subjective sleep quality. We aimed to summarise up-to-date research evidence and to identify the types of dietary supplement that improve subjective sleep quality. [METHODS] Multiple databases (Ovid Emcare, Ovid MEDLINE (R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and APA PsycInfo) were used for searching papers published until August 2020. The changes in sleep quality indices, intervention duration and sample size were extracted from every paper. To analyse the effect of dietary supplements on sleep quality, a random effects model with mean difference (MD) and 95% CI was adopted. The heterogeneity across studies was measured by I [RESULTS] Thirty-one randomised controlled trials of dietary supplements were included. Subjective sleep quality was significantly improved by supplementation of amino acids (MD -1.27, 95% CI -2.35 to -0.20; I [CONCLUSIONS] Amino acids, vitamin D and melatonin supplements were significantly beneficial to improve sleep quality. However, high heterogeneity and wide confidence levels were observed in vitamin D and melatonin. Further research on the effect of magnesium, zinc, resveratrol and nitrate supplementation on improving sleep quality is required.
Read on PubMed (PMID 33441476)
PubMed · 2025
Melatonin Use in the ICU: A Systematic Review and Meta-Analysis
Tang BHY, Manalo J, Chowdhury SR et al. · Critical care medicine
[OBJECTIVES] Melatonin has wide-ranging effects on the body, including the regulation of circadian rhythm, and potentiation of cellular immune and antioxidant activities. In critically ill patients, endogenous melatonin has been shown to be markedly deranged and reduced. Therefore, the purpose of this systematic review and meta-analysis was to determine if exogenous supplementation of melatonin improves patient-centered outcomes. [DATA SOURCES] We searched five electronic databases. [STUDY SELECTION] Randomized clinical trials (RCTs) that compared melatonin to no melatonin in adults admitted to the ICU were identified. [DATA EXTRACTION] We aggregated data as relative risks, mean differences (MDs), and standard mean differences (SMDs) using a random-effects model. Supporting evidence for each effect was evaluated for certainty using the Grading Recommendations, Assessment, Development, and Evaluations approach. [DATA SYNTHESIS] In total, 32 RCTs ( n = 3895 patients) were included. We found that melatonin may reduce delirium (relative risk [RR] 0.72; 95% CI, 0.58-0.89; low certainty), may slightly reduce ICU length of stay (MD -0.57 d; 95% CI, -0.95 to -0.18 d; low certainty), and may improve reported sleep quality (SMD 0.54; 95% CI, 0.01-1.07; low certainty). Melatonin may result in a slight reduction in the frequency of adverse events (low certainty). Evidence was uncertain with regards to the frequency of sleep awakenings, anxiety level, agitation, and post-traumatic stress disorder incidence (all very low certainty), as well as to ICU mortality and post-ICU functional status (both low certainty). [CONCLUSIONS] Our findings suggest that melatonin administration in the critically ill may improve perceived sleep and reduce delirium, without increasing adverse effects. Certainty of evidence was negatively affected by the risk of bias and inconsistency. Future RCTs should focus on identifying optimal dosing, administration timing, improving measurements of sleep outcomes, and target populations.
Read on PubMed (PMID 40662882)
PubMed · 2023
Effects of melatonin on postoperative sleep quality: a systematic review, meta-analysis, and trial sequential analysis
Tsukinaga A, Mihara T, Takeshima T et al. · Canadian journal of anaesthesia = Journal canadien d'anesthesie
[PURPOSE] Postoperative sleep disturbances are common. Although several studies have examined the effect of melatonin on postoperative sleep disturbances, the results have not reached any definitive conclusion. We sought to conduct a systematic review to compare the effects of melatonin and melatonin agonists on postoperative sleep quality with those of placebo or no treatment in adult patients who underwent surgery under general or regional anesthesia. [METHODS] We searched MEDLINE, Cochrane Central Register of Controlled Trials, Embase, Web of Science, ClinicalTrials.gov, and the UMIN Clinical Trials Registry up to 18 April 2022. Randomized clinical trials examining the effects of melatonin or melatonin agonists in patients undergoing general or regional anesthesia with sedation for any surgery were eligible for inclusion. The primary outcome was sleep quality measured using a visual analog scale (VAS). The secondary outcomes were postoperative sleep duration, sleepiness, pain, opioid consumption, quality of recovery, and adverse events. A random-effects model was used to combine the results. We assessed study quality with the Cochrane Risk of Bias Tool version 2. We applied a trial sequential analysis to assess the precision of the combined results. [RESULTS] Eight studies (516 participants) were analyzed for sleep quality. Of those, four studies used only a short duration of melatonin, either on the night before and the day of surgery or only on the day of surgery. A random-effects meta-analysis showed that melatonin did not improve sleep quality measured by VAS compared with placebo (mean difference, -0.75 mm; 95% confidence interval, -4.86 to 3.35), with low heterogeneity (I [CONCLUSION] Our results indicate that melatonin supplementation does not improve postoperative sleep quality measured with the VAS compared with placebo in adult patients (GRADE: moderate). [STUDY REGISTRATION] PROSPERO (CRD42020180167); registered 27 October 2022. RéSUMé: OBJECTIF: Les troubles du sommeil postopératoires sont fréquents. Bien que plusieurs études aient examiné l’effet de la mélatonine sur les troubles du sommeil postopératoires, les résultats n’ont abouti à aucune conclusion définitive. Nous avons tenté de réaliser une revue systématique afin de comparer les effets de la mélatonine et des agonistes de la mélatonine sur la qualité du sommeil postopératoire à ceux d’un placebo ou de l’absence de traitement chez des patients adultes ayant bénéficié d’une intervention chirurgicale sous anesthésie générale ou régionale. MéTHODE: Nous avons effectué des recherches dans les bases de données MEDLINE, le registre Cochrane des essais contrôlés, Embase, Web of Science, ClinicalTrials.gov et le registre des essais cliniques UMIN pour en tirer les manuscrits publiés jusqu’au 18 avril 2022. Les études cliniques randomisées examinant les effets de la mélatonine ou des agonistes de la mélatonine chez des patients bénéficiant d’une anesthésie générale ou régionale avec sédation pour toute intervention chirurgicale étaient éligibles pour l’inclusion. Le critère d’évaluation principal était la qualité du sommeil mesurée à l’aide d’une échelle visuelle analogique (EVA). Les critères d’évaluation secondaires étaient la durée du sommeil postopératoire, la somnolence, la douleur, la consommation d’opioïdes, la qualité de la récupération et les événements indésirables. Un modèle à effets aléatoires a été utilisé pour combiner les résultats. Nous avons évalué la qualité des études en utilisant l’outil de risque de biais de Cochrane version 2.0. Nous avons appliqué une analyse séquentielle des études pour évaluer la précision des résultats combinés. RéSULTATS: Huit études (516 participants) ont été analysées pour déterminer la qualité du sommeil. Parmi celles-ci, quatre études n’ont utilisé la mélatonine que pour une courte durée, c’est-à-dire soit la nuit précédant et le jour de la chirurgie, soit le jour de la chirurgie seulement. Une méta-analyse à effets aléatoires a montré que la mélatonine n’améliorait pas la qualité du sommeil mesurée par une EVA comparativement au placebo (différence moyenne, -0,75 mm; intervalle de confiance à 95 %, -4,86 à 3,35), avec une faible hétérogénéité (I
Read on PubMed (PMID 36977935)
PubMed · 2022
Controlled-release oral melatonin supplementation for hypertension and nocturnal hypertension: A systematic review and meta-analysis
Lee EK, Poon P, Yu CP et al. · Journal of clinical hypertension (Greenwich, Conn.)
Oral melatonin is a potential alternative treatment for hypertension and nocturnal hypertension. However, high-quality and relevant meta-analyses are lacking. This meta-analysis aimed to investigate whether oral melatonin supplementation reduces daytime/asleep blood pressure and cardiovascular risk, improves sleep quality, and is well-tolerated compared with placebo. Relevant articles were searched in multiple databases, including MEDLINE, EMBASE, CINAHL Complete, and the Cochrane Library, from their inception to June 2021. The included studies were randomized controlled trials recruiting patients with hypertension, using oral melatonin as the sole intervention, and investigating its effect on blood pressure. The mean out-of-office (including 24-h, daytime, and asleep) systolic and diastolic blood pressures, sleep quality, and side effects were compared between the melatonin and placebo arms using pairwise random-effect meta-analyses. A risk of bias assessment was performed using the Cochrane risk-of-bias tool. Four studies were included in the analysis and only one study was considered to have a low risk of bias. No study reported on cardiovascular risk or outcomes. Only controlled-release melatonin (not an immediate-release preparation) reduced asleep systolic blood pressure by 3.57 mm Hg (95% confidence interval: -7.88 to .73; I
Read on PubMed (PMID 35388609)
PubMed · 2018
Melatonin and health: an umbrella review of health outcomes and biological mechanisms of action
Posadzki PP, Bajpai R, Kyaw BM et al. · BMC medicine
[BACKGROUND] Our aims were to evaluate critically the evidence from systematic reviews as well as narrative reviews of the effects of melatonin (MLT) on health and to identify the potential mechanisms of action involved. [METHODS] An umbrella review of the evidence across systematic reviews and narrative reviews of endogenous and exogenous (supplementation) MLT was undertaken. The Oxman checklist for assessing the methodological quality of the included systematic reviews was utilised. The following databases were searched: MEDLINE, EMBASE, Web of Science, CENTRAL, PsycINFO and CINAHL. In addition, reference lists were screened. We included reviews of the effects of MLT on any type of health-related outcome measure. [RESULTS] Altogether, 195 reviews met the inclusion criteria. Most were of low methodological quality (mean -4.5, standard deviation 6.7). Of those, 164 did not pool the data and were synthesised narratively (qualitatively) whereas the remaining 31 used meta-analytic techniques and were synthesised quantitatively. Seven meta-analyses were significant with P values less than 0.001 under the random-effects model. These pertained to sleep latency, pre-operative anxiety, prevention of agitation and risk of breast cancer. [CONCLUSIONS] There is an abundance of reviews evaluating the effects of exogenous and endogenous MLT on health. In general, MLT has been shown to be associated with a wide variety of health outcomes in clinically and methodologically heterogeneous populations. Many reviews stressed the need for more high-quality randomised clinical trials to reduce the existing uncertainties.
Read on PubMed (PMID 29397794)
PubMed · 2016
Exogenous Melatonin for Delirium Prevention: a Meta-analysis of Randomized Controlled Trials
Chen S, Shi L, Liang F et al. · Molecular neurobiology
Recently, two high-quality clinical randomized controlled trials (RCTs) regarding the preventive effect of exogenous melatonin on delirium drew inconsistent conclusions. We therefore performed a systemic review to explore whether melatonin had a benefit on delirium prevention. MEDLINE, EMBASE, and Cochrane Library were searched from January 1980 to April 2015 for English language studies. After strict selection and evaluation, the data were extracted from the included four RCTs. The primary outcome of this meta-analysis was the incidence of delirium. The secondary outcome was the improvement of sleep-wake rhythm. A total of four RCTs with 669 elderly patients were included in the present study. Melatonin group showed a tendency to decrease the incidence of delirium (relative risk [RR] 0.41, 95 % confidence interval [CI] 0.15 to 1.13; P = 0.08) compared with control group. In subgroup analysis of the elderly patients in medical wards, melatonin supplementation decreased the incidence of delirium by 75 % (RR 0.25, 95 % CI 0.07 to 0.88; P = 0.03), but not in sleep-wake disturbance (RR 1.24, 95 % CI 0.51 to 3.00; P = 0.64). No differences were found in the incidence of delirium between the two groups in the elderly patients that were presented to surgical wards. In conclusion, melatonin supplementation had a significant preventive effect in decreasing the incidence of delirium in elderly patients that were presented to medical wards. Further studies should provide sufficient evidence about the effect of melatonin on delirium in a large sample size.
Read on PubMed (PMID 26189834)
PubMed · 2025
Effectiveness of melatonin supplementation for improving sleep quality and disease severity in children with atopic dermatitis: a systematic review and meta-analysis
Alghamdi F, Alzahrani DY, Alharthy RF et al. · Frontiers in medicine
[INTRODUCTION] Atopic dermatitis (AD) is a chronic inflammatory skin condition causing pruritus, leading to sleep disturbance and poor quality of life, particularly in children. Effective adjunctive treatments addressing these issues are crucially needed. [OBJECTIVE] To evaluate the effects of melatonin supplementation on sleep quality and disease severity in children with atopic dermatitis through a systematic review and meta-analysis. [MATERIALS AND METHODS] A systematic review with meta-analysis was conducted using three randomized controlled trials (RCTs). Eligible studies compared melatonin supplementation (3-6 mg/day) to placebo. Data was analyzed using a random-effects model with mean differences and standardized mean differences reported at 95% confidence intervals (CIs). Risk of bias was assessed using the Cochrane Risk of Bias Tool 2.0, and heterogeneity was evaluated using I [RESULTS] Melatonin significantly reduced sleep onset latency with a pooled standard mean difference of -0.63 (95% CI: -1.00 to -0.26, [CONCLUSION] Melatonin effectively improves sleep initiation in children with atopic dermatitis and may have modest effects on clinician-rated signs; the clinical importance remains uncertain. It appears safe, but further long-term studies are needed. [SYSTEMATIC REVIEW REGISTRATION] https://www.crd.york.ac.uk/PROSPERO/view/CRD42023439385.
Read on PubMed (PMID 41647028)
Source: All citations are sourced from PubMed (NCBI), the U.S. National Library of Medicine's database of peer-reviewed biomedical literature. Results are filtered to systematic reviews and clinical trials published 2015–2025. This page is for informational purposes only and does not constitute medical advice.