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

Melatonina Mylan

Active Ingredient:
Melatonin
Origin:
EU

Melatonina Mylan (Melatonin)

Melatonin, the active ingredient in Melatonina Mylan, is a melatonin receptor agonist presented as an oral formulation for oral use. It is used to help regulate sleep‑wake cycles in adults experiencing insomnia or jet lag.
GNH India supplies Melatonina Mylan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Viatris Limited

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Indications & Clinical Uses

Melatonina Mylan is a melatonin receptor agonist that acts on the circadian‑regulation pathway to improve sleep quality.

  • Insomnia: helps reduce time to fall asleep and increase total sleep duration.
  • Jet lag: assists in realigning the internal clock after rapid time‑zone travel.
  • Circadian rhythm disturbances: supports synchronization of the sleep‑wake cycle in shift‑work or delayed‑sleep‑phase situations.

How It Works

  • Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking the endogenous hormone that signals darkness. Activation of these G‑protein‑coupled receptors modulates intracellular cyclic AMP and calcium pathways, leading to a phase‑shift of the circadian pacemaker and promotion of sleep onset without directly inducing sedation.

Side Effects

Melatonina Mylan is generally well tolerated, but adverse reactions can occur.

Common Side Effects

  • Drowsiness or daytime sleepiness
  • Headache
  • Dizziness
  • Nausea or mild gastrointestinal discomfort
  • Vivid dreams or altered dream patterns
  • Mild fatigue

Serious or Rare Side Effects

  • Allergic reactions such as rash, itching, or angioedema
  • Severe dizziness or vertigo
  • Mood changes including depression or irritability
  • Hallucinations or vivid nightmares (rare)
  • Significant blood pressure changes (rare)

Precautions & Warnings

When considering melatonin therapy, several safety points should be observed.

  • Pregnancy: safety not established; use only if clearly needed.
  • Breastfeeding: unknown safety; weigh potential benefits against risks.
  • Concomitant CNS depressants: may increase sedation, monitor alertness.
  • Autoimmune disorders: discuss with physician as melatonin can modulate immune function.
  • Elderly patients: start with the lowest effective dose due to increased sensitivity.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Melatonin can interact with several medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

  • CNS depressants (e.g., benzodiazepines, alcohol): additive sedation.
  • Antihypertensives: possible enhancement of blood‑pressure‑lowering effect.
  • Oral contraceptives: may increase melatonin concentrations, requiring observation.

Frequently Asked Questions

Melatonina Mylan contains melatonin, a hormone that helps regulate the sleep‑wake cycle. It is commonly used to treat occasional insomnia, reduce the effects of jet lag after rapid travel across time zones, and assist individuals with circadian rhythm disturbances in achieving a more regular sleep pattern.

Melatonin acts as an agonist at MT1 and MT2 receptors located in the brain’s suprachiasmatic nucleus. By binding these receptors, it mimics the natural nighttime signal, helping to shift the internal clock, promote sleep onset, and stabilize the timing of the circadian rhythm without directly causing sedation.

The appropriate dose of Melatonina Mylan is determined by a qualified healthcare professional based on the individual’s age, condition, and response. Prescribers select the strength and dosing schedule that best fits the patient’s specific sleep‑related needs.

Safety data for melatonin use in pregnancy and lactation are limited. It is generally recommended to avoid routine use unless the potential benefit outweighs any possible risk, and this decision should be made in consultation with a healthcare provider.

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 prescription hypnotics that act on GABA receptors, melatonin works by aligning the body’s internal clock. It is available over the counter, has a different side‑effect profile, and is generally considered safer for short‑term use, though efficacy may vary depending on the underlying sleep disorder.

Melatonina Mylan 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 product is taken orally, typically with a glass of water. It is usually recommended to ingest the dose about 30‑60 minutes before the desired bedtime, following the specific timing instructions provided by the prescribing clinician.

Serious but rare risks include severe allergic reactions such as rash, itching, or angioedema, as well as significant mood changes like depression or irritability. Any signs of an allergic response or unexpected psychological symptoms should prompt immediate medical evaluation.

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

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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