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

Melatonin Orifarm

Active Ingredient:
Melatonin
Origin:
EU

Melatonin Orifarm (Melatonin)

Melatonin, the active ingredient in Melatonin Orifarm, is a melatonin receptor agonist presented as an oral formulation for oral use. It is employed to support normal sleep patterns and to manage various sleep‑related disorders in adults.

GNH India supplies Melatonin Orifarm as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Orifarm Generics A/S

1
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Indications & Clinical Uses

Melatonin acts on the melatonin receptor pathway to support regulation of the sleep‑wake cycle.

  • Insomnia: helps reduce sleep onset latency and improve overall sleep quality in adults.
  • Jet lag: assists in realigning circadian rhythm after rapid east‑west travel.
  • Shift work disorder: promotes daytime sleep for individuals working night shifts.

How It Works

  • Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking the endogenous hormone. Activation of these G‑protein‑coupled receptors modulates intracellular cyclic AMP levels, leading to phase‑shifting of the circadian clock and facilitating the onset of sleep. The overall effect is a normalization of the sleep‑wake rhythm without direct sedation.

Side Effects

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

Common Side Effects

  • Headache: mild to moderate discomfort.
  • Drowsiness: excessive sleepiness during daytime.
  • Dizziness: sensation of light‑headedness.
  • Nausea: mild gastrointestinal upset.
  • Irritability: transient mood changes.
  • Vivid dreams: occasional intense dreaming.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Severe drowsiness: profound sedation interfering with daily activities.
  • Mood disturbances: depression or anxiety exacerbation.
  • Seizures: rare occurrence in predisposed individuals.
  • Hallucinations: visual or auditory disturbances.
  • Cardiovascular effects: rare hypotension or palpitations.

Precautions & Warnings

Before using Melatonin Orifarm, consider the following safety measures.

  • Pregnancy: consult a healthcare professional before use.
  • Breastfeeding: discuss potential risks with a physician.
  • Underlying medical conditions: use caution in patients with epilepsy, depression, or autoimmune disorders.
  • Concomitant CNS depressants: monitor for additive sedation.
  • Alcohol consumption: avoid or limit as it may increase drowsiness.
  • Store at ambient temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Melatonin may interact with other medicines; review the following categories.

Major Interactions (Avoid)

  • Fluoxetine or fluvoxamine (CYP1A2 inhibitors): may increase melatonin plasma levels.
  • Warfarin (anticoagulant): potential enhancement of bleeding risk.
  • Tacrolimus (immunosuppressant): possible alteration of drug concentrations.

Moderate Interactions (Monitor Closely)

  • Benzodiazepines or other CNS depressants: may augment sedation.
  • Antihypertensive agents: possible additive hypotensive effect.
  • Oral contraceptives: may raise endogenous melatonin concentrations.

Frequently Asked Questions

Melatonin Orifarm is used to help regulate the sleep‑wake cycle in adults experiencing insomnia, jet lag, or shift‑work related sleep disturbances. By supporting the body’s natural circadian rhythm, it can improve sleep onset, duration, and overall sleep quality.

Melatonin works by binding to MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus. This interaction signals the body that it is nighttime, helping to synchronize the internal clock and promote the physiological processes that lead to sleep.

The appropriate dose of Melatonin Orifarm is determined by a prescriber based on the individual’s age, condition, and response to therapy. Patients should follow the specific dosing instructions provided by their healthcare professional.

Safety data for melatonin in pregnancy and lactation are limited. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their physician before using Melatonin Orifarm.

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, confirming trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.

Unlike benzodiazepines or antihistamines, melatonin does not act as a central nervous system depressant. It works by aligning the body’s circadian rhythm rather than inducing sedation, which generally results in fewer next‑day drowsiness effects and a lower risk of dependence.

Store Melatonin Orifarm at ambient temperature, below 25 °C, in its original container. Protect it from moisture, direct sunlight, and extreme heat to maintain product stability throughout its shelf life.

Melatonin Orifarm is taken orally, usually with a glass of water. It is commonly taken shortly before bedtime, but the exact timing should follow the prescriber’s recommendation to align with the individual’s sleep schedule.

Serious risks, though rare, include severe allergic reactions such as rash, swelling, or anaphylaxis, as well as profound daytime drowsiness, mood changes, seizures, or hallucinations. Any of these symptoms should prompt immediate medical attention.

Individuals with known hypersensitivity to melatonin, those taking medications that strongly interact (e.g., certain antidepressants or anticoagulants), and patients with uncontrolled epilepsy or severe depression should avoid using Melatonin Orifarm unless advised otherwise by a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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