Product image of Melatonine Tiofarma (Melatonin) supplied by GNH India

Melatonine Tiofarma

Active Ingredient:
Melatonin
Origin:
EU

Melatonine Tiofarma (Melatonin)

Melatonin, the active ingredient in Melatonine Tiofarma, is a melatonin receptor agonist presented as an oral formulation for oral use. It is used to treat insomnia, sleep‑wake rhythm disorders and jet lag in adults.
GNH India supplies Melatonine Tiofarma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Tiofarma B.V.

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Indications & Clinical Uses

Melatonine Tiofarma acts on melatonin receptors to regulate the sleep‑wake cycle and is indicated for several sleep‑related conditions.

  • Insomnia: helps initiate and maintain sleep in individuals with difficulty falling or staying asleep.
  • Sleep‑wake rhythm disorders: assists in synchronising abnormal circadian rhythms such as shift‑work disorder.
  • Jet lag: reduces the time needed to adjust to new time zones after long‑distance travel.

How It Works

  • Melatonin binds as an agonist to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking endogenous melatonin. Activation of these G‑protein‑coupled receptors modulates circadian signalling, promotes the onset of sleep, and helps re‑align the internal biological clock with external light‑dark cycles.

Side Effects

Melatonine Tiofarma may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Headache: mild to moderate pain often resolving without treatment.
  • Dizziness: sensation of light‑headedness, especially after first doses.
  • Daytime sleepiness: residual drowsiness that may affect alertness.
  • Nausea: mild stomach upset or queasiness.
  • Vivid dreams: unusually intense or memorable dreaming.
  • Mild gastrointestinal discomfort: occasional abdominal cramps or loose stools.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, swelling, or angioedema requiring medical attention.
  • Depression or mood changes: emergence of depressive symptoms in susceptible individuals.
  • Seizures: rare occurrence, particularly in patients with a history of epilepsy.
  • Severe hypersensitivity: anaphylactic reactions demanding immediate emergency care.
  • Abnormal heart rhythm: rare cases of arrhythmia reported.

Precautions & Warnings

When considering Melatonine Tiofarma, several safety measures should be observed.

  • Assess sleep hygiene: ensure non‑pharmacologic sleep practices are in place before use.
  • Use lowest effective dose: start with the minimal dose that provides benefit.
  • Avoid operating machinery: refrain from driving or using heavy equipment if daytime drowsiness occurs.
  • Contraindication: do not use in individuals with known hypersensitivity to melatonin.
  • Caution in hepatic impairment: monitor liver function and adjust therapy as needed.
  • Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Melatonin can interact with several medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • CNS depressants (e.g., benzodiazepines, barbiturates): may increase sedation and impair alertness.
  • Anticoagulants (e.g., warfarin): melatonin may enhance anticoagulant effect, raising bleeding risk.
  • Immunosuppressants (e.g., cyclosporine): potential reduction in immunosuppressive activity.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: melatonin may reduce contraceptive effectiveness; monitor cycle changes.
  • Antihypertensives: additive blood‑pressure‑lowering effect may require dose adjustment.
  • CYP1A2 inhibitors (e.g., fluvoxamine): can raise melatonin plasma levels, increasing side‑effect potential.

Frequently Asked Questions

Melatonine Tiofarma contains melatonin and is used to manage insomnia, sleep‑wake rhythm disorders such as shift‑work disorder, and jet lag. It helps regulate the body’s internal clock, facilitating the onset of sleep and improving overall sleep quality in adults.

Melatonin acts as an agonist at the MT1 and MT2 receptors located in the suprachiasmatic nucleus of the brain. By activating these receptors, it mimics the natural hormone released at night, signaling the body that it is time to sleep and helping to synchronize circadian rhythms.

The appropriate dose of Melatonine Tiofarma is determined by the prescribing healthcare professional based on the patient’s condition, age, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for melatonin use in pregnancy and lactation are limited. Healthcare providers should weigh potential benefits against possible risks before prescribing it to pregnant or nursing women. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss use with their physician.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Unlike many prescription hypnotics that act on GABA receptors, melatonin works by directly targeting the body’s circadian system. This mechanism generally results in fewer next‑day residual effects, but efficacy may be lower for severe insomnia. It is often preferred for circadian‑related sleep disturbances and jet lag.

Melatonine Tiofarma should be stored at ambient temperature, below 25 °C, in its original packaging. Protect the product from moisture, excessive heat and direct sunlight to maintain potency throughout its shelf life.

The medication is taken orally, typically with a glass of water. It is usually administered shortly before bedtime, as directed by the prescriber, to align with the natural rise in endogenous melatonin levels during the night.

Serious but rare risks include severe allergic reactions such as rash, swelling or anaphylaxis, and the potential for mood changes like depression. In individuals with seizure disorders, melatonin may lower the seizure threshold. Any concerning symptoms should prompt immediate medical evaluation.

Individuals with known hypersensitivity to melatonin or any excipients in the formulation should avoid use. Caution is also advised for patients with uncontrolled hepatic disease, severe depression, or those taking medications that may interact significantly, such as certain anticoagulants or CNS depressants.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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