Product image of Melatonina Generis (Melatonin) supplied by GNH India

Melatonina Generis

Active Ingredient:
Melatonin
Origin:
EU

Melatonina Generis (Melatonin)

Melatonin, the active ingredient in Melatonina Generis, is a melatonin receptor agonist presented as an oral formulation for oral use. It works by activating MT1 and MT2 receptors to promote sleep onset and is indicated for insomnia, jet lag and other sleep‑wake rhythm disorders in adults.

GNH India supplies Melatonina Generis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product conforms to EU market standards and is manufactured under GMP conditions.

Manufacturer / TM Owner

Generis Farmacêutica, S.A.

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Indications & Clinical Uses

Melatonina Generis is a melatonin receptor agonist used to address disorders of the sleep‑wake cycle.

  • Insomnia: helps reduce sleep onset latency and improve sleep maintenance.
  • Jet lag: assists in resetting circadian rhythm after rapid time‑zone travel.
  • Sleep‑wake rhythm disorders: supports normalization of abnormal sleep patterns such as shift‑work disorder.

How It Works

  • Melatonin binds to MT1 and MT2 receptors located in the suprachiasmatic nucleus of the hypothalamus. Activation of these G‑protein‑coupled receptors modulates intracellular cyclic AMP levels, thereby influencing circadian signaling pathways and facilitating the transition to sleep. The resulting effect is a reduction in sleep latency and stabilization of the sleep‑wake cycle.

Side Effects

Melatonina Generis may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Headache: mild to moderate pain often occurring shortly after ingestion.
  • Dizziness: sensation of light‑headedness or unsteadiness.
  • Daytime sleepiness: residual drowsiness during waking hours.
  • Nausea: mild gastrointestinal upset.
  • Vivid dreams: unusually intense or memorable dreaming.
  • Mild abdominal discomfort: occasional stomach cramps.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, swelling, or hives.
  • Anaphylaxis: rare, severe hypersensitivity requiring immediate medical attention.
  • Mood changes: emergence of depression, anxiety or suicidal thoughts.
  • Cardiac arrhythmia: rare irregular heart rhythm.
  • Severe hypotension: unexpected drop in blood pressure.

Precautions & Warnings

When considering Melatonina Generis, several safety considerations should be observed.

  • Pregnancy: consult a healthcare professional before use.
  • Breastfeeding: discuss potential risks with a physician.
  • Concomitant CNS depressants: monitor for additive sedation.
  • Autoimmune disease: use with caution as melatonin may modulate immune response.
  • Elderly patients: start with the lowest effective dose.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Melatonin can interact with several medication classes; awareness of these interactions helps optimize safety.

Major Interactions (Avoid)

  • Anticoagulants: may increase bleeding risk.
  • Immunosuppressants: may reduce therapeutic efficacy.
  • CYP1A2 inhibitors (e.g., fluvoxamine): can raise melatonin plasma levels.

Moderate Interactions (Monitor Closely)

  • CNS depressants (benzodiazepines, alcohol): additive sedation.
  • Antidiabetic drugs: potential alteration of glucose control.
  • Hormonal contraceptives: possible reduction in melatonin effectiveness.

Frequently Asked Questions

Melatonina Generis contains melatonin, a hormone that helps regulate the sleep‑wake cycle. It is used to manage insomnia, alleviate jet lag after rapid travel across time zones, and treat other sleep‑wake rhythm disorders such as shift‑work disorder.

Melatonin binds to MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus, the central clock that controls circadian rhythms. This binding reduces neuronal activity that promotes wakefulness, thereby facilitating the onset of sleep and helping to synchronize the internal clock with external light‑dark cycles.

The appropriate dose of Melatonina Generis is determined by the prescribing clinician based on the individual’s age, condition, and response to therapy. Patients should follow the dosage instructions provided by their healthcare professional and not adjust the amount without medical guidance.

Safety data for melatonin use in pregnancy and lactation are limited. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider before starting Melatonina Generis.

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 (including any cold‑chain requirements) and necessary import documentation.

Unlike many prescription hypnotics that act on GABA receptors, melatonin works by mimicking the body’s natural hormone to reset circadian rhythms. This mechanism generally results in fewer next‑day residual effects, but efficacy may vary depending on the underlying sleep disorder and individual response.

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

The product is taken orally, usually with a glass of water. It is commonly administered 30‑60 minutes before the desired bedtime, but exact timing should follow the prescriber’s instructions.

Serious but rare risks include severe allergic reactions such as anaphylaxis, significant mood changes like depression or suicidal thoughts, and rare cardiac arrhythmias. Patients experiencing any of these symptoms should seek immediate medical attention.

Individuals with known hypersensitivity to melatonin or any excipients in the formulation should avoid use. Additionally, patients taking certain medications (e.g., anticoagulants, strong CYP1A2 inhibitors) or those with uncontrolled autoimmune disorders should consult a healthcare professional before starting therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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