Product image of Mallozen (Melatonin) supplied by GNH India

Mallozen

Active Ingredient:
Melatonin
Origin:
EU

Mallozen (Melatonin)

Melatonin, the active ingredient in Mallozen, is a melatonin receptor agonist presented as an oral dosage form for oral use. It is used to help regulate the sleep‑wake cycle in individuals with insomnia or other circadian rhythm disturbances.
GNH India supplies Mallozen as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Medice Arzneimittel Pütter Gmbh & Co. Kg

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Indications & Clinical Uses

Mallozen (melatonin) acts on the melatonin receptor pathway to address sleep‑related disorders.

  • Insomnia: assists in reducing sleep onset latency and improving sleep maintenance in adults who have difficulty falling or staying asleep.
  • Sleep‑wake rhythm disorders: helps synchronize disrupted circadian rhythms, such as in shift‑work disorder.
  • Jet lag: supports adjustment of the internal clock after rapid travel across time zones, facilitating faster adaptation to new sleep schedules.

How It Works

  • Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking the endogenous hormone that signals darkness. Activation of these G‑protein‑coupled receptors modulates intracellular cyclic AMP levels, leading to phase‑shifting of the circadian pacemaker and promoting the onset of sleep. The overall effect is a normalization of the sleep‑wake cycle without direct sedation.

Side Effects

Mallozen may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Headache: mild to moderate discomfort often occurring shortly after ingestion.
  • Dizziness: transient light‑headedness that usually resolves without intervention.
  • Daytime sleepiness: occasional residual drowsiness, especially with higher doses.
  • Nausea: mild gastrointestinal upset that subsides with continued use.
  • Vivid dreams: occasional intense or unusual dreaming patterns.

Serious or Rare Side Effects

  • Allergic reaction: rash, itching, swelling, or difficulty breathing requiring immediate medical attention.
  • Severe rash: Stevens‑Johnson‑type skin eruption, though extremely uncommon.
  • Mood changes: rare reports of depression or anxiety exacerbation.
  • Seizures: isolated cases in predisposed individuals, considered very rare.

Precautions & Warnings

Before using Mallozen, consider the following safety measures.

  • Assess underlying conditions: evaluate for depression, autoimmune disorders, or seizure history.
  • Avoid operating machinery: refrain from driving or using heavy equipment if residual drowsiness occurs.
  • Pregnancy and lactation: discuss potential risks with a healthcare professional before use.
  • Concomitant CNS depressants: monitor for additive sedative effects when combined with alcohol or sleep‑inducing medications.
  • Pediatric use: limit to children under specialist supervision due to limited safety data.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Melatonin can influence the activity of several other medicines; awareness of these interactions helps maintain safety.

Major Interactions (Avoid)

  • Warfarin: may enhance anticoagulant effect, increasing bleeding risk.
  • Cyclosporine: potential increase in blood concentrations, risking toxicity.
  • Benzodiazepines: additive central nervous system depression leading to excessive sedation.

Moderate Interactions (Monitor Closely)

  • NSAIDs: possible alteration of gastric protection, monitor for GI irritation.
  • Oral contraceptives: melatonin may affect hormone metabolism; observe for cycle changes.
  • Antihypertensives: potential modest reduction in blood pressure; check readings regularly.
  • Antidepressants (SSRIs): monitor for heightened serotonergic activity.
  • Caffeine: may counteract melatonin’s sleep‑promoting effect, advise timing adjustments.

Frequently Asked Questions

Mallozen contains melatonin, which is used to help manage insomnia and other sleep‑wake rhythm disorders by supporting the body’s natural circadian timing. It may also be employed to alleviate jet lag after rapid travel across time zones.

Melatonin acts as an agonist at MT1 and MT2 receptors in the brain’s suprachiasmatic nucleus. By binding these receptors, it signals darkness to the internal clock, helping to shift and stabilize the circadian rhythm, which promotes the onset of sleep.

The appropriate dose of Mallozen is determined by the prescribing clinician based on the individual’s age, condition, and response. Patients should follow the dosage instructions provided by their healthcare professional and not adjust the amount on their own.

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 physician before using Mallozen.

To request Mallozen, 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.

Unlike traditional sedative hypnotics, melatonin works by normalizing the circadian clock rather than directly depressing the central nervous system. This mechanism often results in fewer next‑day residual effects, but efficacy may vary depending on the underlying sleep disorder.

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

Mallozen is taken orally, typically with a glass of water. It is usually taken shortly before the desired bedtime, following the dosing schedule prescribed by a healthcare professional.

Serious, though rare, risks include allergic reactions such as rash, swelling, or difficulty breathing, and mood changes like depression. Any signs of severe hypersensitivity or unexpected psychological symptoms should prompt immediate medical evaluation.

Individuals with known hypersensitivity to melatonin, those taking medications that have major interactions (e.g., warfarin, cyclosporine, benzodiazepines), and patients with uncontrolled seizure disorders should avoid Mallozen unless advised otherwise by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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