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 manage insomnia, jet lag and sleep‑wake rhythm disorders in adults.

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

Manufacturer / TM Owner

Alissa Healthcare Research Limited

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Indications & Clinical Uses

Melatonin acts on melatonin MT1 and MT2 receptors to support normal sleep physiology. It is indicated for the following conditions:

  • Insomnia: facilitates sleep onset and improves sleep continuity in adults.
  • Jet lag: helps realign the internal clock after rapid time‑zone travel.
  • Sleep‑wake rhythm disorders: assists in normalising disrupted circadian patterns such as shift‑work disorder.

How It Works

  • Melatonin binds selectively to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking endogenous melatonin. Activation of these G‑protein‑coupled receptors reduces neuronal firing, promotes the night‑time signal, and synchronises peripheral clocks, thereby facilitating the transition to sleep and stabilising circadian rhythms.

Side Effects

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

Common Side Effects

  • Drowsiness: excessive sleepiness during daytime.
  • Headache: mild to moderate head pain.
  • Dizziness: sensation of light‑headedness.
  • Nausea: mild gastrointestinal upset.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Severe mood changes: depression or suicidal thoughts.
  • Seizures: rare occurrence of convulsive episodes.
  • Hormonal effects: alterations in reproductive hormone levels.
  • Daytime impairment: significant sleepiness affecting driving or operating machinery.

Precautions & Warnings

Before using melatonin, consider the following safety measures:

  • Evaluate underlying sleep disorders: confirm diagnosis before initiating therapy.
  • Avoid operating heavy machinery: assess daytime drowsiness risk.
  • Caution with CNS depressants: monitor additive sedative effects.
  • Pediatric use: restrict to prescribed situations only.
  • Pregnancy and lactation: consult a healthcare professional before use.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Melatonin may interact with other medicines; awareness of the interaction level is important.

Major Interactions (Avoid)

  • Warfarin: increased risk of bleeding.
  • Cyclosporine: potential alteration of immunosuppressive effect.
  • Fluoxetine: enhanced serotonergic activity.
  • Carbamazepine: reduced melatonin efficacy.

Moderate Interactions (Monitor Closely)

  • Caffeine: may diminish sleep‑promoting effect.
  • Alcohol: additive sedation.
  • Benzodiazepines: increased central nervous system depression.
  • NSAIDs: possible impact on platelet function.

Frequently Asked Questions

Melatonin is used to help regulate the sleep‑wake cycle. It is commonly prescribed for insomnia, to reduce the effects of jet lag after rapid travel across time zones, and for various sleep‑wake rhythm disorders such as shift‑work disorder.

Melatonin works by binding to MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus. This mimics the body’s natural hormone, signalling that it is night‑time, which helps to initiate sleep and align the internal circadian clock with the external environment.

The appropriate dose of melatonin is determined by a prescriber based on the individual’s age, condition, and response to therapy. Dosage may vary widely, and patients should follow the specific 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 healthcare provider before using melatonin.

To order melatonin, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Unlike many prescription hypnotics that act on GABA receptors, melatonin works by mimicking the natural hormone that regulates circadian rhythms. It is generally considered to have a milder side‑effect profile and is often preferred for short‑term use or for adjusting sleep patterns related to travel or shift work.

Melatonin should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture, excessive heat and direct sunlight to maintain its stability and potency.

Melatonin is taken orally, typically as a tablet or capsule, with water. It is usually taken shortly before bedtime, but the exact timing and frequency should follow the prescribing clinician’s instructions.

Serious risks, though rare, include severe allergic reactions such as anaphylaxis, significant mood changes like depression or suicidal thoughts, and rare seizure activity. Patients should seek immediate medical attention if they experience any of these symptoms.

Melatonin should be avoided by individuals with known hypersensitivity to the product, those taking certain medications that have major interactions (e.g., warfarin, cyclosporine, fluoxetine, carbamazepine), and by children unless specifically prescribed by a qualified healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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