The Efficacy of Melatonergic Receptor Agonists Used in Clinical Practice in Insomnia Treatment: Melatonin, Tasimelteon, Ramelteon, Agomelatine, and Selected Herbs.
Study Design
- Jenis Studi
- Review
- Intervensi
- The Efficacy of Melatonergic Receptor Agonists Used in Clinical Practice in Insomnia Treatment: Melatonin, Tasimelteon, Ramelteon, Agomelatine, and Selected Herbs. None
- Pembanding
- Placebo
- Arah Efek
- Positive
- Risiko Bias
- Unclear
Abstract
Insomnia is a common and complex disorder, rooted in the dysregulation of circadian rhythms, impaired neurotransmitter function, and disturbances in sleep-wake homeostasis. While conventional hypnotics such as benzodiazepines and Z-drugs are effective in the short term, their use is limited by a high potential for dependence, cognitive side effects, and withdrawal symptoms. In contrast, melatonergic receptor agonists-melatonin, ramelteon, tasimelteon, and agomelatine-represent a pharmacologically targeted alternative that modulates MT1 and MT2 receptors, which are pivotal to the regulation of circadian timing and sleep initiation. Clinical evidence supports the efficacy of these agents in reducing sleep onset latency, extending total sleep duration, and re-aligning disrupted circadian rhythms, particularly among older individuals and patients with non-24 h sleep-wake disorders. Notably, agomelatine offers additional antidepressant properties through selective antagonism of the 5-HT2C receptor in micromolar concentrations. In contrast, its agonistic activity at melatonergic receptors is observed in the low sub-nanomolar range, which illustrates the complexity of this drug's interactions with the human body. All compounds reviewed demonstrate a generally favorable safety and tolerability profile. Accumulating evidence highlights that selected medicinal plants, such as chamomilla, lemon balm, black cumin, valeriana, passionflower and lavender, may exert relevant hypnotic or anxiolytic effects, thus complementing melatonergic strategies in the management of insomnia. This structured narrative review presents a comprehensive analysis of the molecular pharmacology, receptor affinity, signaling pathways, and clinical outcomes associated with melatonergic agents. It also examines their functional interplay with serotonergic, GABAergic, dopaminergic, and orexinergic systems involved in arousal and sleep regulation. Through comparative synthesis of pharmacokinetics and neurochemical mechanisms, this work aims to inform the development of evidence-based strategies for the treatment of insomnia and circadian rhythm sleep-wake disorders.
Full Text
Figures
Tables
Table 5
| Criterion | Melatonergic Drugs | Herbal Preparations |
|---|---|---|
| Examples | Melatonin, Ramelteon, Tasimelteon, Agomelatine | |
| Mechanism of Action | MT1/MT2 agonism, 5-HT2C antagonism (agomelatine) | GABA modulation, serotonin activity, antioxidant effects |
| Clinical Efficacy | High (multiple RCTs and meta-analyses) | Limited (mostly pilot trials) |
| Safety | High, low abuse potential | High, but risk of interactions and allergies |
| Use in Severe Insomnia | Confirmed by multiple trials | Not confirmed |
| Cost | Moderate to high | Low |
| Availability | Prescription only (except melatonin OTC in some regions) | OTC, dietary supplements |
| Additional Benefits | Antidepressant effects (agomelatine) | Anxiolytic, adaptogenic potential |
Table 6
| ICSD-3-TR | The International Classification of Sleep Disorders, Third Edition |
| ICD-11 | 11th Revision of the International Classification of Diseases |
| DSM-5 | 5th edition of the Diagnostic and Statistical Manual of Mental Disorders |
| SCN | Suprachiasmatic nucleus |
| LTP | Long-term potentiation |
| cAMP | Cyclic adenosine monophosphate |
| AC | Adenylate cyclase |
| PKA | Protein kinase A |
| P-CREB | Phosphorylated CREB |
| PKC | Protein kinase C |
| GC | Guanylyl cyclase |
| PLC | Phospholipase C |
| cGMP | Cyclic GMP |
| DAG | Diacylglycerol |
| IP3 | Inositol trisphosphate |
| PVN | Paraventricular nucleus |
| VTA | Ventral tegmental area |
| OX1R/OX2R | Orexin-1-receptor/Orexin-2-receptor |
| GIRK | G protein–regulated inward rectifier |
| NMDA | N-methyl-D-aspartate |
| DMH | Hypothalamus |
| NREM | Non-rapid eye movement |
| REM | Rapid eye movement |
| VLPO | Ventrolateral preoptic nucleus |
| TMN | Tuberomammillary nucleus |
| LC | Locus coeruleus |
| LH/PF | Lateral hypothalamus/Perifornical area |
| GPCR | G protein-coupled receptor |
| NQO2 | Quinone reductase 2 |
| TST | Total sleep time |
| sTST | Subjective total sleep time |
| SL | Sleep latency |
| sSL | Subjective sleep latency |
| ASD | Autism spectrum disorder |
| LPS | Latency to persistent sleep |
| SE | Sleep efficiency |
| oSOL | Objective sleep onset latency |
| EMA | European Medicines Agency |
| MDD | Major depressive disorder |
| LSEQ | Leeds Sleep Evaluation Questionnaire |
| CGI | Clinical Global Impression |
| OR | Odds ratio |
| PSQI | Pittsburgh Sleep Quality Index |
| TCIM | Integrative medicines |
| WHO | World Health Organization |
| GAD | Generalized anxiety disorder |
| HRSD | Hamilton Rating Scale for Depression |
| GABA | Gamma-aminobutyric acid |
| NO | Nitric oxide |
References
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
- Untitled
Used In Evidence Reviews
Similar Papers
Journal of sleep research · 2017
European guideline for the diagnosis and treatment of insomnia.
Chronobiology international · 2012
Circadian typology: a comprehensive review.
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017
Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.
Movement disorders : official journal of the Movement Disorder Society · 2011
The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease.
Cell · 1981
Regulation of terminal differentiation of cultured human keratinocytes by vitamin A.
Journal of neuroendocrinology · 2003