Product image of Melatonin Vitabalans (Melatonin) supplied by GNH India

Melatonin Vitabalans

Active Ingredient:
Melatonin
Origin:
EU

Melatonin Vitabalans (Melatonin)

Melatonin, the active ingredient in Melatonin Vitabalans, is a melatonin receptor agonist presented as an oral supplement for oral use. It is used to help regulate the sleep‑wake cycle and may be prescribed for insomnia and other sleep‑wake rhythm disorders in adults.

GNH India supplies Melatonin Vitabalans as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and other healthcare providers worldwide, with consistent quality and regulatory compliance.

Manufacturer / TM Owner

Vitabalans Oy

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Indications & Clinical Uses

Melatonin acts on the melatonin receptor pathway to address disorders of sleep regulation.

  • Insomnia: helps reduce sleep onset latency and improve sleep maintenance in adults.
  • Circadian rhythm sleep‑wake disorder: assists in aligning the internal clock with desired sleep times.
  • Delayed sleep phase disorder: facilitates earlier sleep onset by advancing the circadian phase.

How It Works

  • Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking endogenous melatonin. This activation modulates circadian signaling, reduces neuronal firing that promotes wakefulness, and facilitates the initiation of sleep, thereby helping to synchronize the body's internal clock with the external light‑dark cycle.

Side Effects

Melatonin is generally well tolerated, but adverse reactions can occur.

Common Side Effects

  • Headache: mild to moderate headache reported after ingestion.
  • Dizziness: transient light‑headedness, especially at higher doses.
  • Daytime sleepiness: residual drowsiness if taken too late.
  • Gastrointestinal upset: nausea or mild stomach discomfort.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, or swelling indicating hypersensitivity.
  • Paradoxical insomnia: worsening of sleep difficulty in a minority of users.
  • Mood changes: rare reports of depression or vivid dreams that disturb sleep.

Precautions & Warnings

Melatonin should be used with awareness of specific safety considerations.

  • Pregnancy: safety not established; avoid unless benefits outweigh potential risks.
  • Breastfeeding: limited data; consider possible exposure to the infant.
  • Elderly: start with the lowest effective dose and monitor for excessive sedation.
  • Concomitant CNS depressants: may increase overall sedation; use caution.
  • Store at ambient temperature below 25°C: keep in the original pack, protect from moisture and light.

Avoid Interactions

Melatonin can interact with several medicines, requiring attention to avoid reduced efficacy or increased adverse effects.

Major Interactions (Avoid)

  • Fluvoxamine: strong CYP1A2 inhibition can markedly raise melatonin concentrations.
  • Anticoagulants (e.g., warfarin): potential for increased bleeding risk.
  • Immunosuppressants (e.g., cyclosporine): may diminish melatonin’s therapeutic effect.

Moderate Interactions (Monitor Closely)

  • CYP1A2 inducers (e.g., smoking, carbamazepine): may lower melatonin levels.
  • Sedative CNS depressants (e.g., benzodiazepines, antihistamines): additive sedation.
  • Oral contraceptives: can increase melatonin plasma concentrations.

Frequently Asked Questions

Melatonin Vitabalans is used to help regulate the sleep‑wake cycle in adults who experience insomnia or other sleep‑wake rhythm disorders, such as delayed sleep phase disorder. By supporting the body’s natural circadian rhythm, it can improve sleep onset and overall sleep quality.

Melatonin works by binding to MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus. This activation signals the body that it is nighttime, helping to lower alertness, synchronize the internal clock, and promote the onset of sleep.

The appropriate dose of melatonin is determined by the prescribing clinician based on the individual’s age, condition, and response. Dosage may vary from low‑dose formulations to higher strengths, and the prescriber will provide specific instructions.

Safety data for melatonin in pregnancy and lactation are limited. It is generally advised to avoid use unless the potential benefit justifies the possible risk, and the decision should be made in consultation with a healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Unlike traditional hypnotics that act on GABA receptors, melatonin is a hormone‑based therapy that targets the body’s circadian system. It is generally considered less sedating and has a different safety profile, making it suitable for patients who need a physiologic approach to sleep regulation.

Melatonin Vitabalans should be stored at ambient temperature below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability.

The product is taken orally, usually as a tablet or capsule, with water. It is typically taken shortly before the intended bedtime, following the dosage instructions provided by the prescriber.

Serious but rare risks include allergic reactions such as rash or swelling, paradoxical worsening of insomnia, and mood changes like depression or vivid dreams. Any unexpected symptoms should be reported to a healthcare professional promptly.

Melatonin should be avoided by individuals with known hypersensitivity to melatonin, those taking certain medications that interact significantly (e.g., strong CYP1A2 inhibitors), and patients where the prescriber determines that the risks outweigh the benefits, such as certain pregnant or breastfeeding women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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