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

Melatonine Biogaran

Active Ingredient:
Melatonin
Origin:
EU

Melatonine Biogaran (Melatonin)

Melatonin, the active ingredient in Melatonine Biogaran, is a melatonin receptor agonist presented as an oral formulation for oral use. It helps regulate the circadian rhythm and is employed in the management of sleep‑related disorders such as insomnia, delayed sleep phase disorder and jet lag.

GNH India supplies Melatonine Biogaran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution, ensuring product integrity throughout the supply chain.

Manufacturer / TM Owner

Biogaran

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Indications & Clinical Uses

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

  • Insomnia (sleep onset): Improves ability to fall asleep and reduces sleep latency.
  • Delayed Sleep Phase Disorder: Shifts circadian timing to promote earlier sleep onset.
  • Jet Lag: Helps synchronize the internal clock after rapid time‑zone travel.
  • Shift Work Disorder: Supports adaptation to irregular work schedules.
  • Non‑24‑Hour Sleep‑Wake Rhythm Disorder: Assists in aligning the sleep‑wake cycle with a 24‑hour day.

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 reduces neuronal firing during the night, promoting sleep initiation and stabilizing circadian rhythms. By modulating intracellular cyclic AMP and calcium signaling, melatonin influences downstream pathways that regulate melatonin‑dependent physiological processes. These actions collectively help reset the internal clock and facilitate a normal sleep‑wake pattern.

Side Effects

Melatonin is generally well tolerated, but some users may experience adverse reactions.

Common Side Effects

  • Drowsiness: Excessive sleepiness during daytime.
  • Headache: Mild to moderate head pain.
  • Dizziness: Light‑headed sensation.
  • Nausea: Stomach discomfort or queasiness.
  • Vivid dreams: Unusual or intense dreaming.

Serious or Rare Side Effects

  • Allergic reaction: Rash, itching, swelling, or difficulty breathing.
  • Mood changes: Depression or increased anxiety.
  • Hormonal effects: Altered menstrual cycles in women.
  • Blood pressure changes: Hypertension or hypotension.
  • Severe abdominal pain: Persistent or worsening abdominal discomfort.

Precautions & Warnings

When considering melatonin therapy, certain precautions should be observed to ensure safe use.

  • Pregnancy: Use only if clearly needed and prescribed by a healthcare professional.
  • Breastfeeding: Evaluate risk‑benefit; consult a physician before use.
  • Children: Dose and duration should be determined by a pediatric specialist.
  • Concomitant medications: Review potential interactions, especially with anticoagulants or CNS depressants.
  • Underlying disorders: Caution in patients with epilepsy, depression, or autoimmune diseases.
  • Store at ambient temperature: Keep below 25 °C, in the original container, protected from moisture and light.

Avoid Interactions

Melatonin may interact with other medicines, altering its effectiveness or increasing risk of side effects.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): May increase bleeding risk.
  • Immunosuppressants (e.g., cyclosporine): Potential reduction in drug efficacy.

Moderate Interactions (Monitor Closely)

  • CNS depressants (e.g., benzodiazepines, alcohol): Additive sedative effect.
  • Antidiabetic agents: May affect blood glucose control.
  • Hormonal contraceptives: Possible alteration of hormone levels.
  • Antihypertensives: May enhance blood pressure‑lowering effect.

Frequently Asked Questions

Melatonine Biogaran contains melatonin, which is used to help regulate the sleep‑wake cycle. It is indicated for conditions such as insomnia, delayed sleep phase disorder, jet lag, shift‑work sleep disturbances, and other circadian rhythm disorders where restoring a normal sleep pattern is desired.

Melatonin works by binding to MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus. This mimics the body’s natural hormone, signaling that it is night time, which reduces neuronal activity, promotes sleep onset, and helps synchronize the internal circadian clock with external light‑dark cycles.

The appropriate dose of melatonin is individualized. A prescriber will consider the specific sleep disorder, patient age, timing of administration, and any concurrent medications before recommending a dosage regimen. Patients should follow the exact instructions provided by their healthcare professional.

Safety data for melatonin in pregnancy and lactation are limited. It should only be used if the potential benefit outweighs any possible risk, and this decision must be made by a qualified healthcare provider. Women who are pregnant or nursing should discuss alternatives with their doctor.

To request Melatonine Biogaran, 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 such as benzodiazepines or Z‑drugs because it acts on the body’s natural circadian system rather than directly depressing the central nervous system. This generally results in fewer next‑day residual effects, but its efficacy is most pronounced for circadian‑related sleep problems rather than severe insomnia.

The product should be stored at ambient temperature, preferably below 25 °C. Keep it in the original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability throughout its shelf life.

Melatonine Biogaran is taken orally, typically shortly before the desired bedtime. The exact timing and whether it should be taken with food depend on the prescriber’s instructions. Swallow the tablet or capsule whole with a glass of water unless directed otherwise.

Serious but rare risks include allergic reactions such as rash, swelling, or breathing difficulties, and significant mood changes like depression or heightened anxiety. Patients experiencing any of these symptoms should seek immediate medical attention and discontinue the product until evaluated.

Melatonin is not recommended for individuals with known hypersensitivity to melatonin, uncontrolled epilepsy, severe depression, or those taking certain medications that may interact dangerously, such as anticoagulants or immunosuppressants, without medical supervision. Pregnant or breastfeeding women should also avoid use unless specifically advised by a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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