Product image of Melatonin supplied by GNH India

Melatonin

Active Ingredient:
Melatonin
Origin:
EU

Melatonin

Melatonin, the active ingredient in this product, is a melatonin receptor agonist presented as an oral dosage form for oral use. It assists the body’s natural sleep‑wake cycle and is employed to improve sleep onset and quality in adults with insomnia, jet lag, or circadian rhythm sleep disorders.

GNH India supplies melatonin as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring product quality through stringent manufacturing and distribution standards. The company adheres to EU GMP guidelines and provides reliable logistics for global markets.

Manufacturer / TM Owner

Orion Corporation

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Indications & Clinical Uses

  • Melatonin acts on melatonin receptors to help normalize the sleep‑wake cycle in various sleep‑related conditions.
  • Insomnia: improves sleep onset and reduces nighttime awakenings in adults.
  • Jet lag: facilitates adjustment of the circadian clock after rapid time‑zone travel.
  • Circadian rhythm sleep disorder: stabilizes abnormal sleep timing in shift‑work or delayed sleep phase syndrome.

How It Works

  • Melatonin binds with high affinity to MT1 and MT2 receptors in the suprachiasmatic nucleus and other brain regions. Activation of MT1 reduces neuronal firing that promotes sleep, while MT2 modulates phase shifting of the circadian clock. By mimicking endogenous melatonin, the drug synchronizes the internal biological rhythm with the external light‑dark cycle, facilitating sleep initiation.

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

Serious or Rare Side Effects

  • Allergic skin reactions (rash, itching, swelling)
  • Severe hypersensitivity (anaphylaxis)
  • Mood changes (depression, irritability)

Precautions & Warnings

  • When considering melatonin therapy, several safety measures and warnings should be observed.
  • Consult healthcare provider: verify suitability for individual health conditions.
  • Avoid use with driving: potential residual drowsiness may impair performance.
  • Pregnancy and breastfeeding: discuss risks with a physician before use.
  • Concurrent medications: review possible interactions with other sleep‑affecting agents.
  • Store at ambient temperature below 25°C: keep in original container, protect from moisture and light.

Avoid Interactions

Melatonin can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): may increase bleeding risk.
  • Immunosuppressants (e.g., cyclosporine): potential reduction in drug effectiveness.
  • Central nervous system depressants (e.g., benzodiazepines): additive sedative effect.

Moderate Interactions (Monitor Closely)

  • CYP1A2 inhibitors (e.g., fluvoxamine): may raise melatonin plasma levels.
  • Oral contraceptives: may enhance melatonin’s effect on hormone balance.
  • Antihypertensives: possible additive blood pressure lowering.

Frequently Asked Questions

Melatonin is used to treat sleep‑related conditions such as insomnia, jet lag, and circadian rhythm sleep disorders. It helps regulate the body’s internal clock, making it easier to fall asleep and maintain a regular sleep pattern.

Melatonin works by binding to MT1 and MT2 receptors in the brain, especially in the suprachiasmatic nucleus. This interaction reduces neuronal activity that promotes wakefulness and helps shift the timing of the circadian rhythm, thereby supporting the onset of sleep.

The appropriate dose of melatonin is determined by a prescriber based on the individual’s age, condition, and response to therapy. Patients should follow the dosage instructions provided by their healthcare professional and not self‑adjust the amount.

Safety data for melatonin use 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 starting melatonin.

To order melatonin, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies 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 antihistamine or benzodiazepine sleep aids because it works by mimicking a natural hormone rather than depressing the central nervous system. It generally has a favorable safety profile and is less likely to cause dependence, but its efficacy may be modest compared with prescription hypnotics for severe insomnia.

Melatonin should be stored at ambient temperature below 25 °C, in its original packaging, protected from moisture and direct light. Keeping the product in a dry, cool place helps maintain its potency throughout its shelf life.

Melatonin is taken orally, usually as a tablet, capsule or liquid. It can be taken with or without food, typically 30‑60 minutes before bedtime, as directed by a healthcare professional.

Serious risks, although rare, include severe allergic reactions such as anaphylaxis, significant mood changes like depression or irritability, and pronounced hormonal effects that may alter menstrual cycles. Any signs of these reactions should prompt immediate medical attention.

Melatonin should be avoided by individuals with known hypersensitivity to the product, children without medical supervision, and patients taking certain medications such as anticoagulants or immunosuppressants unless advised by a physician. Those with uncontrolled epilepsy or severe psychiatric disorders should also consult a healthcare provider before use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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