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

Melatonina Polfarmex

Active Ingredient:
Melatonin
Origin:
EU

Melatonina Polfarmex (Melatonin)

Melatonin, the active ingredient in Melatonina Polfarmex, is a melatonin receptor agonist presented as an oral formulation for oral use. It is used to help regulate the sleep‑wake cycle and is indicated for individuals experiencing difficulty falling or staying asleep, including primary insomnia and circadian rhythm sleep‑wake disorders.

GNH India supplies Melatonina Polfarmex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, adhering to stringent quality standards and providing regulatory documentation for cross‑border distribution.

Manufacturer / TM Owner

Polfarmex S.A.

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Indications & Clinical Uses

Melatonin acts on the melatonin receptor pathway to address sleep‑related disorders.

  • Insomnia: assists in reducing sleep onset latency and improving total sleep time.
  • Sleep‑wake rhythm disorders: helps synchronize the circadian clock to a more regular pattern.
  • Jet lag: supports faster adjustment of the internal clock after rapid time‑zone travel.

How It Works

  • Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking endogenous melatonin. This activation modulates the circadian signaling cascade, leading to a reduction in neuronal firing that promotes sleep onset and helps align the internal biological clock with external light‑dark cycles.

Side Effects

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

Common Side Effects

  • Drowsiness or daytime sleepiness
  • Headache
  • Dizziness
  • Nausea
  • Vivid dreams

Serious or Rare Side Effects

  • Allergic skin reactions such as rash or urticaria
  • Severe hypersensitivity including anaphylaxis
  • Mood changes such as depression or agitation
  • Hormonal disturbances affecting puberty in children (rare)

Precautions & Warnings

Melatonin should be used with caution in specific populations and clinical situations.

  • Use in children: limit to short‑term under medical supervision.
  • Pregnancy and lactation: avoid unless benefits outweigh potential risks.
  • Concomitant CNS depressants: monitor for additive sedation.
  • Underlying psychiatric conditions: assess risk of mood alterations.
  • Store at ambient temperature below 25°C: keep in original container, protect from moisture and light.

Avoid Interactions

Melatonin can interact with several medication classes, requiring attention to potential additive effects.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): may increase bleeding risk.
  • Immunosuppressants (e.g., cyclosporine): potential reduction in efficacy.

Moderate Interactions (Monitor Closely)

  • CNS depressants (benzodiazepines, alcohol): enhanced sedative effect.
  • Antidiabetic agents: possible alteration of glucose control.
  • Hormonal contraceptives: may reduce contraceptive effectiveness.
  • Fluoroquinolone antibiotics: may increase risk of QT prolongation.

Frequently Asked Questions

Melatonina Polfarmex contains melatonin, which is used to help individuals who have difficulty falling asleep or staying asleep. It is commonly prescribed for primary insomnia and for disorders where the sleep‑wake cycle is disrupted, such as circadian rhythm sleep‑wake disorders and jet lag.

Melatonin works by binding to MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus. This mimics the natural hormone released at night, signaling the body that it is time to sleep and helping to align the internal clock with the external light‑dark environment.

The appropriate dose of Melatonina Polfarmex is determined by a qualified prescriber based on the patient’s age, condition, and response to therapy. Dosage may vary, and the prescribing clinician will provide specific instructions.

Safety data for melatonin in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and this decision must be made by 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.

Melatonin differs from traditional hypnotics because it targets the body’s natural sleep‑regulating pathways rather than inducing sedation. It is generally considered to have a favorable safety profile, especially for short‑term use, whereas many prescription sleep aids may carry higher risks of dependence and next‑day impairment.

Store Melatonina Polfarmex at ambient temperature below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and avoid storing it in areas with high humidity or temperature fluctuations.

Melatonina Polfarmex is taken orally, typically with a glass of water. It is usually taken shortly before the desired bedtime, following the dosing instructions provided by the prescribing clinician.

Serious but rare risks include severe allergic reactions such as rash, urticaria or anaphylaxis, and hormonal disturbances that could affect puberty in children. Any signs of severe hypersensitivity or unexpected mood changes should prompt immediate medical evaluation.

Individuals with known hypersensitivity to melatonin, those taking certain anticoagulants or immunosuppressants without medical supervision, and patients with uncontrolled psychiatric disorders should avoid using melatonin unless a healthcare professional determines it is appropriate.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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