Delving into the Latest Updates on Melatonin with Synapse

A Phase 4 open, single-arm, pilot study to evaluate the effectiveness and tolerability of a 4-week flexible dose regimen of Melatonin (5-10mg/day) and cognitive behavioural therapy for insomnia (CBT-I) for improving sleep quality and quantity and patient-reported outcomes in Post-Total Knee Arthroplasty/Replacement Adult Patients - NIL

Start Date03 Apr 2026

Sponsor / Collaborator-

TCTR20240529005

/ Not yet recruitingPhase 3IIT

Efficacy of melatonin to normalize the cytokines network and balance the oxidative stress in methamphetamine-induced psychosis patients: a double-blinded randomized controlled trial.

Start Date02 Jun 2025

Sponsor / Collaborator

University of Chulalongkorn

100 Clinical Results associated with Melatonin

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100 Translational Medicine associated with Melatonin

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100 Patents (Medical) associated with Melatonin

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39,853

Literatures (Medical) associated with Melatonin

01 Jan 2026·Neural Regeneration Research

Targeting the glymphatic system to promote α-synuclein clearance: a novel therapeutic strategy for Parkinson’s disease

Article

Author: Liu, Zhenghao ; Chen, Jiang-fan ; Lian, Xiaoyue ; Tong, Luyao ; Gan, Zuobin ; Liu, Yuntao ; Li, Zhihui ; Yan, Qingshan ; Qiu, Linan

The excessive buildup of neurotoxic α-synuclein plays a pivotal role in the pathogenesis of Parkinson’s disease, highlighting the urgent need for innovative therapeutic strategies to promote α-synuclein clearance, particularly given the current lack of disease-modifying treatments. The glymphatic system, a recently identified perivascular fluid transport network, is crucial for clearing neurotoxic proteins. This review aims to synthesize current knowledge on the role of the glymphatic system in α-synuclein clearance and its implications for the pathology of Parkinson’s disease while emphasizing potential therapeutic strategies and areas for future research. The review begins with an overview of the glymphatic system and details its anatomical structure and physiological functions that facilitate cerebrospinal fluid circulation and waste clearance. It summarizes emerging evidence from neuroimaging and experimental studies that highlight the close correlation between the glymphatic system and clinical symptom severity in patients with Parkinson’s disease, as well as the effect of glymphatic dysfunction on α-synuclein accumulation in Parkinson’s disease models. Subsequently, the review summarizes the mechanisms of glymphatic system impairment in Parkinson’s disease, including sleep disturbances, aquaporin-4 impairment, and mitochondrial dysfunction, all of which diminish glymphatic system efficiency. This creates a vicious cycle that exacerbates α-synuclein accumulation and worsens Parkinson’s disease. The therapeutic perspectives section outlines strategies for enhancing glymphatic activity, such as improving sleep quality and pharmacologically targeting aquaporin-4 or its subcellular localization. Promising interventions include deep brain stimulation, melatonin supplementation, γ-aminobutyric acid modulation, and non-invasive methods (such as exercise and bright-light therapy), multisensory γ stimulation, and ultrasound therapy. Moreover, identifying neuroimaging biomarkers to assess glymphatic flow as an indicator of α-synuclein burden could refine Parkinson’s disease diagnosis and track disease progression. In conclusion, the review highlights the critical role of the glymphatic system in α-synuclein clearance and its potential as a therapeutic target in Parkinson’s disease. It advocates for further research to elucidate the specific mechanisms by which the glymphatic system clears misfolded α-synuclein and the development of imaging biomarkers to monitor glymphatic activity in patients with Parkinson’s disease. Findings from this review suggest that enhancing glymphatic clearance is a promising strategy for reducing α-synuclein deposits and mitigating the progression of Parkinson’s disease.

31 Dec 2025·Annals of Medicine

Exposure to artificial lighting at night: from an ecological challenge to a risk factor for glucose dysmetabolism and gestational diabetes? Narrative review

Review

Author: Ilias, Ioannis ; Milionis, Charalampos ; Zabuliene, Lina ; Koukkou, Eftychia

INTRODUCTIONArtificial lighting at night (ALAN) leads to pervasive light pollution, affecting ecosystems and human health globally. Satellite assessments reveal widespread nocturnal illumination worldwide and research indicates adverse health effects. Environmental light pollution disrupts natural cycles, affecting the behavior and reproduction of various organisms.AIM/METHODIn this narrative review we aimed to present research on the effects of ALAN on glucose metabolism and diabetes and hone on its recently reported association with gestational diabetes (GDM).RESULTSConflicting data exist on the effects of melatonin's administration vis-à-vis glycemia, with some studies suggesting beneficial outcomes for patients with type 2 diabetes mellitus and insomnia. Ambient light influences plasma glucose, with bright light increasing both fasting and postprandial glucose levels. Perinatal light exposure is linked to later-life health risks and prenatal exposure to ALAN is linked to fetal macrosomia. Analyzing European ALAN data in conjunction with epidemiological records for GDM reveals a notable probable association. Additionally, recent research from China (one case-control and two cohort studies) has shown that exposure to ALAN during pregnancy significantly increases the risk of GDM.DISCUSSION/CONCLUSIONDespite progress, interdisciplinary research is needed to understand the impact of light pollution on health, especially regarding disrupted light-dark cycles and physiological functions relevant to conditions like GDM. At present, the simplest advice for all people and particularly for women who anticipate pregnancy, or for pregnant women, is to ensure a totally dark environment during sleep time.

31 Dec 2025·Journal of the International Society of Sports Nutrition

International Society of Sports Nutrition Position Stand: Long-Chain Omega-3 Polyunsaturated Fatty Acids

Review

Author: Dickerson, Broderick L. ; Candow, Darren G. ; Campbell, Bill I. ; Tinsley, Grant M. ; Heileson, Jeffery L. ; Leonard, Megan ; Kerksick, Chad M. ; Cordingley, Dean M. ; Kalman, Douglas S. ; Forbes, Scott C. ; Antonio, Jose ; Cornish, Stephen M. ; Jäger, Ralf ; Cannataro, Roberto ; Kreider, Richard B. ; Abou Sawan, Sidney ; Stout, Jeffrey R. ; Bongiovanni, Tindaro ; Arent, Shawn M.

Position Statement: The International Society of Sports Nutrition (ISSN) presents this position based on a critical examination of the literature surrounding the effects of long-chain omega-3 polyunsaturated fatty acid (ω-3 PUFA) supplementation on exercise performance, recovery, and brain health. This position stand is intended to provide a scientific foundation for athletes, dietitians, trainers, and other practitioners regarding the effects of supplemental ω-3 PUFA in healthy and athletic populations. The following conclusions represent the official position of the ISSN: Athletes may be at a higher risk for ω-3 PUFA insufficiency.Diets rich in ω-3 PUFA, including supplements, are effective strategies for increasing ω-3 PUFA levels.ω-3 PUFA supplementation, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), has been shown to enhance endurance capacity and cardiovascular function during aerobic-type exercise.ω-3 PUFA supplementation may not confer a muscle hypertrophic benefit in young adults.ω-3 PUFA supplementation in combination with resistance training may improve strength in a dose- and duration-dependent manner.ω-3 PUFA supplementation may decrease subjective measures of muscle soreness following intense exercise.ω-3 PUFA supplementation can positively affect various immune cell responses in athletic populations.Prophylactic ω-3 PUFA supplementation may offer neuroprotective benefits in athletes exposed to repeated head impacts.ω-3 PUFA supplementation is associated with improved sleep quality.ω-3 PUFA are classified as prebiotics; however, studies on the gut microbiome and gut health in athletes are currently lacking.

64

News (Medical) associated with Melatonin

26 Mar 2025

·www.prnewswire.com

NEURIM PHARMACEUTICALS RECEIVES EUROPEAN MARKETING AUTHORIZATION FOR PEDIATRIC PROLONGED-RELEASE MELATONIN (SLENYTO®) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

TEL AVIV, Israel, March 26, 2025 /PRNewswire/ -- Neurim Pharmaceuticals ("Neurim") announces that the European Commission has approved the extension of the indication to include the treatment of insomnia in children with attention deficit hyperactivity disorder (ADHD). The European Commission decision followed the recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January 2025. Slenyto® is a child-appropriate prolonged release melatonin formulation that was first approved in the EU in 2018 for the treatment of insomnia in children with autism spectrum disorder (ASD) and/ or Smith-Magenis Syndrome. In 2024, the indication was extended to neurogenetic disorders (NGDs). Slenyto® is the only authorised medication for insomnia in these disorders. The adopted wording for the newly extended indication is: "Slenyto® is indicated for the treatment of insomnia: In children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or neurogenetic disorders with aberrant diurnal melatonin secretion and /or nocturnal awakenings, where sleep hygiene measures have been insufficient In children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient "We recognise there is significant unmet need and high demand for addressing sleep maintenance and duration as well as sleep initiation difficulties of children with ADHD, who suffer from impaired sleep. The European Commission (EC) granted marketing authorization (MA) of Slenyto® for insomnia in children with ADHD is a major move to satisfy this need." says Prof. Nava Zisapel, CEO of Neurim Pharmaceuticals. Prof. Carmen Schroder, MD, PhD, France, and Prof. Oliviero Bruni, MD, PhD, Italy, comment: " Slenyto® is a prolonged-release formulation of melatonin that delivers melatonin over the course of the night, mimicking the endogenous release profile in healthy subjects. Therefore, Slenyto® has the potential to treat the pathophysiology of insomnia in the population of children with neurodevelopmental disorders, among which ADHD, improving sleep latency, sleep continuity and total nighttime sleep duration, in particular in those who do not produce sufficient endogenous melatonin. Slenyto® has been specifically formulated for use in children and has a favorable safety profile. Subsequent improvements in child behavior (mainly due to longer uninterrupted sleep), parent satisfaction and quality of life (mainly affected by the child's behavior) are expected. The treatment will address a significant need in the medical management of many children and adolescents with ADHD". ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) Sleep impairment is a common comorbidity in ADHD, with up to 70% of children reported to experience disrupted sleep, starting at an early age. Sleep duration and the number of nighttime awakenings in children with ADHD differ from those of typically developing children from a very young age – often before formal ADHD diagnosis. Co-occurring sleep problems in children with ADHD have been shown to predict more severe core symptoms, exacerbate daytime sleepiness, and reduce quality of life in both patients and caregivers. Current practices recommend parent-directed behavioral sleep interventions as first-line treatment for pediatric insomnia in ADHD. Slenyto® is a unique pharmacological treatment for insomnia in children and adolescents with ADHD that would address not only sleep initiation but also sleep maintenance and sleep duration disorders. ABOUT SLENYTO ® Slenyto® is an age-appropriate prolonged-release formulation of melatonin, a hormone involved in the regulation of the circadian clock and sleep. The mini-tablet's innovative formulation was specifically designed to facilitate ease of swallowing without resistance in pediatric ASD, NGD and ADHD populations, in response to the unmet need in the field of paediatric insomnia. Slenyto® delivers melatonin over the night to mimic the endogenous melatonin release profile in healthy subjects. In Phase III study in ASD and SMS children and adolescents, with and without ADHD, Slenyto® improved sleep latency, sleep continuity, and total nighttime sleep duration. The positive effect on sleep maintenance and duration was associated with an improvement in externalizing behavior, which correlated with improvement in parents' well-being. Analysis of Slenyto effect on the primary endpoint, total sleep time, demonstrated the same level of improvement in participants with and without ADHD comorbidity. The mechanism of action of Slenyto® on sleep latency, sleep maintenance and total sleep time is independent of the background disorder. Therefore, any patient with a neurodevelopmental disorder with sleep disturbances associated with aberrant diurnal melatonin secretion patterns and/or insufficient nighttime melatonin secretion will benefit from Slenyto®. ABOUT NEURIM PHARMACEUTICALS Neurim Pharmaceuticals Ltd. () is a neuroscience drug discovery and development company. Its first approved drug, CIRCADIN®, is approved for patients over the age of 55 who are suffering from insomnia and is commercially available in 45 countries around the world. Neurim has a strong and innovative product pipeline targeting central nervous system (CNS) disorders. Contact: Guy Manor, VP Commercial Operations, [email protected] WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Clinical Result

25 Feb 2025

·www.drugs.com

Night Shift Workers Might Lower Cancer Risk With Melatonin

TUESDAY, Feb. 25, 2025 -- Night shift workers face an increased risk of cancer, as their disrupted sleep cycle causes wear and tear on their DNA. But taking melatonin might help ward off this risk, a new study suggests. Folks on the night shift taking melatonin had a substantial increase in their urine of a biochemical that indicated better DNA repair while they sleep, researchers reported Feb. 24 in the journal Occupational & Environmental Medicine . “Melatonin supplementation may prove to be a viable intervention strategy to reduce the burden of cancer among night shift workers,” concluded the research team led by Dr. Parveen Bhatti , a distinguished scientist with the BC Cancer Research Institute at the University of British Columbia in Canada. People who work night shifts typically have lower levels of melatonin, a hormone that helps synchronize sleep/wake cycles. Melatonin is produced in response to a person’s exposure to sunlight. This compromises the body’s ability to repair DNA damage that occurs as part of daily life, increasing their risk of cancer, researchers said. To see if boosting a person’s melatonin might offset this damage, researchers recruited 40 night shift workers and randomly assigned half of them to take a 3 mg melatonin pill at bedtime every day for four weeks. The other half took a placebo pill. All the participants worked at least two consecutive night shifts every week, lasting at least seven hours a night for at least six months, researchers said. Researchers then compared urine samples taken at the start and end of the four-week trial to check participants’ levels of 8-hydroxy-2′-deoxyguanosine (8-OH-dG), a chemical produced when cells repair DNA damage. Higher levels of 8-OH-dG indicate that the body is doing a better job repairing damaged DNA, researchers added. Results showed that people taking melatonin had 80% more 8-OH-dG in their urine following daytime sleep. Melatonin has been shown to promote genetic pathways that are involved in DNA repair, researchers said. Low levels of melatonin might affect the body’s ability to recognize and repair damaged DNA. These results warrant further studies in longer-term trials involving more people, researchers concluded. “Assessing long-term efficacy is critical since those who work night shifts for many years would need to consistently consume melatonin supplements over that time frame to maximize the potential cancer prevention benefits,” researchers concluded. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

25 Feb 2025

·www.drugs.com

Melatonin Improves DNA Damage Repair Capacity in Night Shift Workers

TUESDAY, Feb. 25, 2025 -- For night shift workers, melatonin supplementation seems to improve oxidative DNA damage repair capacity, according to a study published online Feb. 24 in Occupational & Environmental Medicine . Umaimah Zanif, from the British Columbia Cancer Research Institute in Vancouver, Canada, and colleagues examined whether melatonin supplementation would improve oxidative DNA damage repair among night shift workers in a parallel-arm randomized placebo-controlled trial involving 40 night shift workers. Supplements were consumed before day sleep during a four-week period. Creatinine-adjusted 8-hydroxy-2'-deoxyguanosine (8-OH-dG) measured in urine was an indicator of oxidative DNA damage repair capacity, with higher concentrations indicative of better repair. The researchers observed a borderline statistically significant 1.8-fold increase in urinary 8-OH-dG excretion during day sleep in association with the melatonin intervention (95 percent confidence interval, 1.0 to 3.2; P = 0.06). During the subsequent night shift, there was no statistically significant difference in 8-OH-dG excretion (melatonin versus placebo excretion ratio, 0.9; 95 percent confidence interval, 0.6 to 1.5; P = 0.7). "Assessing long-term efficacy is critical since those who work night shifts for many years would need to consistently consume melatonin supplements over that time frame to maximize the potential cancer prevention benefits," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Melatonin

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External Link

KEGG	Wiki	ATC	Drug Bank
D08170	Melatonin	N05CH01	DB01065

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Autism Spectrum Disorder	Liechtenstein	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Autism Spectrum Disorder	Iceland	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Autism Spectrum Disorder	Norway	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Autism Spectrum Disorder	European Union	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Smith-Magenis Syndrome	Iceland	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Smith-Magenis Syndrome	European Union	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Smith-Magenis Syndrome	Norway	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Smith-Magenis Syndrome	Liechtenstein	RAD Neurim Pharmaceuticals EEC SARL	20 Sep 2018
Sleep Initiation and Maintenance Disorders	Iceland	RAD Neurim Pharmaceuticals EEC SARL	29 Jun 2007
Sleep Initiation and Maintenance Disorders	Norway	RAD Neurim Pharmaceuticals EEC SARL	29 Jun 2007
Sleep Initiation and Maintenance Disorders	Liechtenstein	RAD Neurim Pharmaceuticals EEC SARL	29 Jun 2007
Sleep Initiation and Maintenance Disorders	European Union	RAD Neurim Pharmaceuticals EEC SARL	29 Jun 2007

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	NDA/BLA	European Union	RAD Neurim Pharmaceuticals EEC SARL	30 Jan 2025
Sleep Initiation and Maintenance Disorders	NDA/BLA	China	TOA Pharmaceuticals Co., Ltd.	05 Feb 2024
Sleep Initiation and Maintenance Disorders	NDA/BLA	China	Nobelpharma Co., Ltd.	05 Feb 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03498131 (CTgov)	Early Phase 1	Multiple Sclerosis, Relapsing-Remitting \| Multiple sclerosis relapse	30	3 mg Melatonin (3 mg Melatonin)	ejtcrfoczz(rwprinepxs) = hpulyqfncw pcdaicmxpa (ntdijfejye, ykcsjjuhfs - unniermntp) View more	-	25 Mar 2025
				5 mg Melatonin (5 mg Melatonin)	ejtcrfoczz(rwprinepxs) = wuwmdozyyk pcdaicmxpa (ntdijfejye, giijzgcsgn - gbjkluoeoj) View more
NCT00512070 (CTgov)	Not Applicable	Bipolar Disorder \| Schizoaffective disorder \| Schizophrenia	40	olanzapine+melatonin (IIA (0.3mg Day Melatonin))	umvrllllvo(uahnfvesbt) = xokrtmxvqb jfblmhfefx (ykiuyzjasi, ygkgyvauzb - goslzfcltq) View more	-	05 Dec 2024
				olanzapine+melatonin (IIB (3.0 mg/Day Melatonin))	umvrllllvo(uahnfvesbt) = fkunmlyyih jfblmhfefx (ykiuyzjasi, yzwaaeeios - vwksmwrnvn) View more
UEGW2024	Not Applicable	Abdominal Pain	-	Melatonin	elpchredrz(pumumboebp) = gdbstjbfic bscuimyjyt (dqclfdzlmt, 0.62 - 1.75) View more	-	13 Oct 2024
NCT02251041 (CAPITL, CTgov)	Phase 2	Reperfusion Injury	143	C1-Inhibitor+Epoprostenol+Infliximab+Melatonin+Alfa-tocopherol+Human recombinant erythropoietin+Glutathione	snavnbxucm(zyfbunbdyn) = gwmcpzhgjf ufbdbafokw (grsfljtjzw, nuumsfqftq - bkqfanqvlm) View more	-	23 Aug 2024
EAN2024	Not Applicable	Multiple Sclerosis	-	Melatonin 6mg	jouduqvbnh(diclwlsmsb) = ziklzhzmku ouicqbwfhp (gglmdmwdvs ) View more	-	28 Jun 2024
ENDO2024	Not Applicable	First line cortisol \| melatonin \| ACTH ... View more	-	Melatonin	sshodoakhm(ulhiazstvv) = zizuvkrdfx pfxddobiud (fgsihmyssl ) View more	-	01 Jun 2024
NCT04474483 (COVID-19, CTgov)	Phase 2	COVID-19	8	Placebo (Methylcellulose) capsule (Control)	cfzswrzxbj(eblwoukyet) = yrmjvxrnzx nbtihsupai (oqewjliuty, pwizylbgvj - fdcqkramvz) View more	-	07 Feb 2024
				Melatonin (Melatonin)	cfzswrzxbj(eblwoukyet) = xjhjnpcuvn nbtihsupai (oqewjliuty, booixwtbti - taeotooyci) View more
WSC2023	Not Applicable	-	-	melatonin (Preschool-aged children (1-4 years))	dgrnkwfetu(vusnhecoeu) = uunfomeilw pakhtjazsr (wrxyviecou )	-	23 Oct 2023
				melatonin (School-aged children (5-9 years))	dgrnkwfetu(vusnhecoeu) = ctmdkpovgo pakhtjazsr (wrxyviecou )
UEGW2023	Not Applicable	Gastroesophageal Reflux	-	Aligastril gel (alginate+melatonin+chamomile)	ftmrkrvzoz(dsfauivlyc) = byakusphse ivazeragks (tqlvmlbvnz )	-	15 Oct 2023
				Different PPI	ftmrkrvzoz(dsfauivlyc) = jzzalevrkq ivazeragks (tqlvmlbvnz )
NCT03150797 (MAP, CTgov)	Phase 2	Migraine Disorders	72	Melatonin (Melatonin 3mg)	grtxbcfpim(ojztewqxwy) = ktnqsysprf dwbxbtzfeo (iqkjrusvhq, bwmnbicnyk - bztkylfelv) View more	-	13 Oct 2023
				Melatonin (Melatonin 6mg)	grtxbcfpim(ojztewqxwy) = buxwbnhvwd dwbxbtzfeo (iqkjrusvhq, hukptjcblo - srkyxlqswh) View more