Melarena [Melatonin]

Formulation and Packaging

Coated tablets, dosage 0.3 mg and 3 mg

Active ingredient: synthetic melatonin 0.3/3 mg

Inactive ingredients: calcium hydrophosphate dihydrate 67.37 mg, microcrystalline cellulose 25 mg, sodium croscarmellose 2 mg, povidone K25 3.33 mg, fumed silica 0.5 mg, talc 1 mg and calcium stearate 0.5 mg.

Application and Dosage

To be administered orally. The dosage is 1 tablet daily 30-40 minutes before sleep. Duration of treatment course is to be prescribed by a doctor (6-8 weeks). If necessary, the treatment courses can be repeated.

The dose of 0.3 mg is sufficient in most cases.

Side Effects

Allergic response, headache, nausea, vomiting, diarrhea, morning sleepiness or edema.

Counterindications

Hypersensitivity to melatonin and other components of the drug, autoimmune diseases, lymphogranulomatosis, leukemia, lymphoma, myeloma, epilepsy, diabetes mellitus, chronic kidney failure and other kidney diseases, pregnancy, lactation and children under 18 years of age.

Overdose

Cases of overdose are not registered.

Drug Interaction

Melarena is incompatible with monoamine oxidase inhibitors, glucocorticoids and cyclosporine.
It enhances the effect of CNS depressants and beta blockers.

It is not recommended to co-administer Melarena with nonsteroidal anti-inflammatory and hormonal drugs.

Storage Conditions

Keep out of the reach of children. Store in a dark place at a temperature not higher than 25°C (77°F). Shelf life is 2 years.

Description

Melarena is an adaptogen, sedative and hypnotic drug based on a synthetic analogue of pineal hormone melatonin. It is used in case of jet lag, adjusts sleep-wake cycles in people whose daily work schedule changes (shift-work disorder), and helps blind people establish a day and night cycle. It stabilises circadian rhythms.

It increases levels of gamma-Aminobutyric acid and serotonin in the midbrain and hypothalamus as it regulates the pyridoxal kinase which influences the synthesis of these compounds. The drug inhibits the secretion of gonadotropins and other pituitary gland hormones (corticotropin, thyroid stimulating hormone and somatotropin). It normalizes daily changes in body activity and temperature, improves brain activity and reduces irritability. Melarena has a positive effect on night sleep. It helps fall asleep, reduces night time awakenings and facilitates morning awakening.

The drug has also been proven effective in adapting to rapid change of time zones while travelling. It reduces stress and weather sensitivity and stabilises the neuroendocrine system. Melarena has immunomodulating and antioxidant properties. The drug is non-addictive. It has been shown that the natural production of melatonin declines with age, so it is better to use melatonin at an older age.

Indications

Prevention and treatment of:

• desynchronosis (alterations to the body's circadian rhythms caused by rapid long-distance trans-meridian (east–west or west–east) travel or working shifts and jet lag);
• weather sensitivity;
• fatigue and sleep disorders;
• depression

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  2. Malhotra et al (2004) The Therapeutic Potential of Melatonin: A Review of the Science https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1395802/
  3. Buscemi et al (2004) Melatonin for Treatment of Sleep Disorders: Summary
  4. https://www.ncbi.nlm.nih.gov/books/NBK11941/
  5. Pandi-Perumal et al (2006) Melatonin: Nature's most versatile biological signal? https://www.ncbi.nlm.nih.gov/pubmed/16817850
  6. Ferracioli-Oda et al (2013) Meta-analysis: melatonin for the treatment of primary sleep disorders https://www.ncbi.nlm.nih.gov/pubmed/23691095
  7. I Kostoglou-Athanassiou (2013) Therapeutic applications of melatonin https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3593297/
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  10. Masters et al (2015) Melatonin, the Hormone of Darkness: From Sleep Promotion to Ebola Treatment https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4334454/
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  12. Xie et al (2017) A review of sleep disorders and melatonin https://www.ncbi.nlm.nih.gov/pubmed/28460563
  13. Meng et al (2017) Dietary Sources and Bioactivities of Melatonin https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5409706/
  14. N Zisapel (2018) New perspectives on the role of melatonin in human sleep, circadian rhythms and their regulation https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6057895/
  15. Zwart et al (2018) Long-Term Melatonin Therapy for Adolescents and Young Adults with Chronic Sleep Onset Insomnia and Late Melatonin Onset: Evaluation of Sleep Quality, Chronotype, and Lifestyle Factors Compared to Age-Related Randomly Selected Population Cohorts https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5872230/


Type: Adaptogen




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