Product image of Melatonin supplied by GNH India

Melatonin

Active Ingredient:
Melatonin
Origin:
EU

Melatonin

Melatonin, the active ingredient in Melatonin, is a melatonin receptor agonist presented as a tablet for oral use. It helps regulate the circadian rhythm and is used to promote sleep onset in adults experiencing insomnia, jet lag, or other circadian‑related sleep disturbances.

GNH India supplies Melatonin as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing consistent quality and regulatory compliance for global distribution. The company adheres to EU GMP standards and offers batch‑specific certificates of analysis for each shipment.

Manufacturer / TM Owner

Medice Arzneimittel Pütter Gmbh & Co. Kg

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Indications & Clinical Uses

  • Melatonin is a melatonin receptor agonist used to address sleep‑related disorders.
  • Insomnia: improves sleep onset and maintenance in adults with difficulty falling or staying asleep.
  • Jet lag: assists in realigning the circadian rhythm after rapid east‑west travel.
  • Circadian rhythm sleep disorder: supports sleep regulation in shift‑work or delayed sleep phase syndrome.

How It Works

  • Melatonin acts as an agonist at the MT1 and MT2 receptors in the suprachiasmatic nucleus of the hypothalamus. Activation of these receptors synchronizes the endogenous circadian clock, reduces neuronal firing during the night, and facilitates the onset of sleep by mimicking the body’s natural melatonin surge.

Side Effects

Melatonin 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 nightmares
  • Mild fatigue

Serious or Rare Side Effects

  • Allergic reactions such as rash, itching, or swelling
  • Severe daytime somnolence affecting alertness
  • Mood changes including depression or anxiety
  • Hallucinations or confusion (rare)
  • Abnormal heart rhythm or palpitations (very rare)

Precautions & Warnings

  • When using melatonin, consider the following precautions.
  • Assess sleep disorder before initiating therapy: confirm diagnosis and suitability.
  • Avoid operating machinery or driving if drowsy: monitor for impaired alertness.
  • Use with caution in hepatic impairment: metabolism may be altered.
  • Not recommended for children unless prescribed by a specialist.
  • Avoid concurrent use with other sedatives without medical advice.
  • Store at room temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Melatonin may interact with other medications; monitor accordingly.

Major Interactions (Avoid)

  • Concurrent use with benzodiazepines or other sedative hypnotics: risk of excessive sedation.
  • Co‑administration with anticoagulants (e.g., warfarin): possible increased bleeding risk.

Moderate Interactions (Monitor Closely)

  • Antidepressants (SSRIs, SNRIs): may alter melatonin metabolism.
  • Oral contraceptives: can increase melatonin plasma levels.
  • Anticonvulsants (e.g., carbamazepine): may reduce melatonin effectiveness.
  • Caffeine-containing products: may diminish sleep‑promoting effect.
  • NSAIDs: may increase risk of gastrointestinal upset.

Frequently Asked Questions

Melatonin is used to help regulate the sleep‑wake cycle and is indicated for short‑term management of insomnia, jet lag, and other sleep disturbances related to circadian rhythm disorders in adults.

Melatonin binds to MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus, signaling darkness and helping to synchronize the internal clock, which promotes the onset of sleep.

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

Safety data for melatonin in pregnancy and lactation are limited, and the pregnancy category is unknown. It should only be used if clearly needed and prescribed by a qualified healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com with 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.

Unlike benzodiazepines or Z‑drugs, melatonin works by mimicking a natural hormone rather than depressing the central nervous system. It generally has a milder side‑effect profile, but its efficacy may be lower for severe insomnia, making it suitable for mild to moderate sleep disturbances.

Melatonin tablets should be stored at room temperature, below 25 °C, in the original packaging, protected from moisture and direct sunlight to maintain potency.

Melatonin is taken orally, typically as a tablet, and should be swallowed with water. It is usually taken shortly before the intended bedtime, following the prescriber’s guidance.

Serious risks, though rare, include severe allergic reactions, marked daytime drowsiness that impairs alertness, mood changes such as depression or anxiety, and, in very uncommon cases, cardiac rhythm disturbances.

Melatonin should be avoided in individuals with known hypersensitivity to the product, in children unless specifically prescribed, and in patients taking interacting sedatives or anticoagulants without medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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