Product image of Melatonite (Melatonin) supplied by GNH India

Melatonite

Active Ingredient:
Melatonin
Origin:
EU

Melatonite (Melatonin)

Melatonin, the active ingredient in Melatonite, is a sleep‑disorder agent presented as an unspecified strength/tablet for oral use. It helps regulate the circadian rhythm and is used to manage insomnia and jet lag in adults.

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

Manufacturer / TM Owner

Pharma Nord Aps (Vojens)

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Indications & Clinical Uses

  • Melatonite (melatonin) acts on the melatonin receptor pathway to support sleep regulation.
  • Insomnia: improves sleep onset and maintenance in adults.
  • Jet lag: assists in realigning the internal clock after rapid time‑zone travel.
  • Delayed sleep phase syndrome: helps advance sleep timing to a more conventional schedule.

How It Works

  • Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking the endogenous hormone that signals darkness. This activation modulates the circadian clock, reduces neuronal firing in wake‑promoting areas, and promotes the onset of sleep. By synchronizing peripheral oscillators, it facilitates a more regular sleep‑wake cycle without directly inducing sedation.

Side Effects

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

Common Side Effects

  • Headache: mild to moderate intensity.
  • Dizziness: transient sensation of light‑headedness.
  • Daytime sleepiness: occasional lingering drowsiness.
  • Nausea: mild gastrointestinal upset.
  • Vivid dreams: unusual or intense dreaming.
  • Mild stomach discomfort: occasional abdominal irritation.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, swelling, or difficulty breathing.
  • Mood changes: depression or irritability.
  • Severe dizziness: prolonged vertigo or loss of balance.
  • Hallucinations: visual or auditory disturbances.
  • Seizures: rare occurrence in predisposed individuals.
  • Severe depression: worsening of depressive symptoms.

Precautions & Warnings

  • When considering Melatonite, several safety measures are recommended.
  • Assess renal function: evaluate kidney status before initiating therapy.
  • Consult healthcare provider: discuss use in children, adolescents, or the elderly.
  • Avoid operating machinery: potential drowsiness may impair performance.
  • Do not combine with alcohol: may enhance sedative effects.
  • Pregnancy safety: benefits and risks should be weighed with a physician.
  • Store at ambient temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Fluoxetine (CYP1A2 inhibitor): may increase melatonin plasma levels.
  • Warfarin (anticoagulant): potential enhancement of anticoagulant effect.
  • Cyclosporine (immunosuppressant): possible reduction in immunosuppressive efficacy.

Moderate Interactions (Monitor Closely)

  • Benzodiazepines (sedative): additive drowsiness.
  • Oral contraceptives: may lower melatonin effectiveness.
  • SSRIs (antidepressants): possible alteration of sleep architecture.

Frequently Asked Questions

Melatonite contains melatonin, an over‑the‑counter agent used to help regulate the sleep‑wake cycle. It is commonly employed to treat insomnia, alleviate jet lag after rapid travel across time zones, and assist individuals with delayed sleep phase syndrome in achieving a more conventional sleep schedule.

Melatonin acts as an agonist at MT1 and MT2 receptors located in the brain’s suprachiasmatic nucleus. By mimicking the natural hormone released in darkness, it signals the body that night has arrived, helping to synchronize the internal circadian clock and promote the onset of sleep without directly causing sedation.

The appropriate dose of Melatonite is determined by a qualified prescriber based on the individual’s age, condition, and response to therapy. Healthcare professionals consider factors such as severity of insomnia or travel schedule before recommending a specific dosage regimen.

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 healthcare provider before starting Melatonite.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity of Melatonite. 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 many prescription hypnotics that act on GABA receptors to induce sedation, melatonin works by aligning the body’s circadian rhythm. This mechanism often results in fewer next‑day residual effects, making it a preferred option for short‑term sleep disturbances and jet‑lag management.

Melatonite should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight, and excessive heat to maintain its stability and potency throughout its shelf life.

Melatonite is taken orally, typically with a glass of water. It is usually recommended to ingest the tablet about 30‑60 minutes before the desired bedtime, following the dosage instructions provided by the prescribing clinician.

Serious but rare risks include allergic reactions such as rash, swelling, or difficulty breathing, as well as mood alterations like depression or severe dizziness. Patients experiencing any of these symptoms should seek immediate medical attention.

Individuals with known hypersensitivity to melatonin or any excipients in the formulation should avoid Melatonite. Additionally, patients with uncontrolled severe renal impairment, pregnant or breastfeeding women without medical advice, and those taking medications that have major interactions with melatonin should not use it without professional guidance.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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