Product image of Melatonine Ace (Melatonin) supplied by GNH India

Melatonine Ace

Active Ingredient:
Melatonin
Origin:
EU

Melatonine Ace (Melatonin)

Melatonin, the active ingredient in Melatonine Ace, is a melatonin receptor agonist presented as an oral formulation for oral use. It is used to help regulate the sleep‑wake cycle in adults experiencing insomnia, jet lag or other circadian rhythm disturbances.

GNH India supplies Melatonine Ace as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides batch‑tested product for global distribution.

Manufacturer / TM Owner

Ace Pharmaceuticals Bv

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Indications & Clinical Uses

  • Melatonine Ace is a melatonin receptor agonist used to address sleep‑related disorders.
  • Insomnia: helps initiate and maintain sleep in individuals with difficulty falling or staying asleep.
  • Jet lag: reduces the time needed to adjust to new time zones after long‑distance travel.
  • Sleep‑wake rhythm disorders: supports synchronization of the circadian clock in shift‑workers or those with delayed sleep phase syndrome.

How It Works

  • Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking the endogenous hormone released by the pineal gland during darkness. Activation of these G‑protein‑coupled receptors modulates intracellular cyclic AMP levels, leading to phase‑shifting of the circadian pacemaker and promoting sleep onset. By reinforcing the physiological night‑time signal, the drug helps align the internal clock with the external light‑dark cycle.

Side Effects

Adverse reactions to melatonin are generally mild but should be recognized.

Common Side Effects

  • Drowsiness or daytime sleepiness
  • Headache
  • Nausea

Serious or Rare Side Effects

  • Allergic skin reactions such as rash or pruritus
  • Mood changes including depression or agitation
  • Hormonal effects such as altered menstrual cycles

Precautions & Warnings

  • Before initiating therapy, consider the following safety measures.
  • Assess underlying conditions: evaluate for sleep apnea or depression prior to use.
  • Avoid concurrent use with sedatives: may increase central nervous system depression.
  • Limit use in children: safety and efficacy have not been established in pediatric populations.
  • Discontinue if allergic reaction occurs: seek medical attention promptly.
  • Store at below 25°C: keep in the original container, protect from moisture and light.

Avoid Interactions

Melatonin may interact with several medication classes; monitoring is advised.

Major Interactions (Avoid)

  • Benzodiazepines and other CNS depressants: additive sedation.
  • Anticoagulants (e.g., warfarin): possible increased bleeding risk.
  • Immunosuppressants (e.g., cyclosporine): may reduce drug efficacy.

Moderate Interactions (Monitor Closely)

  • Caffeine: may counteract the sleep‑inducing effect.
  • Oral contraceptives: melatonin may alter hormone levels.
  • Antidepressants (SSRIs): potential for increased serotonergic activity.

Frequently Asked Questions

Melatonine Ace contains melatonin, which is used to help manage sleep‑related conditions such as insomnia, jet lag after long‑distance travel, and disorders of the sleep‑wake rhythm. By supporting the body’s natural circadian signaling, it can facilitate the onset of sleep and improve overall sleep quality in adults.

Melatonin acts as an agonist at the MT1 and MT2 receptors located in the suprachiasmatic nucleus of the brain. Activation of these receptors mimics the hormone’s natural nighttime rise, signaling the body that it is dark, which helps to synchronize the internal clock and promote sleep initiation.

The appropriate dose of Melatonine Ace is determined by the prescribing healthcare professional based on the individual’s age, condition, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Safety data for melatonin use during pregnancy or lactation are limited. Healthcare providers generally advise caution and may recommend avoiding the product unless the potential benefit outweighs any possible risk. Patients should discuss their specific situation with a qualified professional.

To place an order, 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.

Melatonin differs from traditional sedative sleep aids such as benzodiazepines or antihistamines because it works by regulating the circadian clock rather than directly depressing the central nervous system. This mechanism often results in fewer next‑day residual effects, but its efficacy is most pronounced when the sleep problem is related to timing rather than severe insomnia.

Melatonine Ace should be stored at temperatures below 25 °C, in its original packaging, and protected from moisture and direct light. Keeping the product in a dry, cool environment helps maintain its potency and ensures stability throughout its shelf life.

The product is taken orally, typically with a glass of water. It is usually recommended to ingest the dose shortly before the desired bedtime, following the timing guidance provided by the prescriber to align with the natural rise of endogenous melatonin.

Serious but uncommon risks include severe allergic reactions such as rash, itching, swelling or anaphylaxis, and mood disturbances like depression or agitation. Hormonal effects, such as changes in menstrual cycles, have also been reported. Any of these symptoms should prompt immediate medical evaluation.

Individuals with known hypersensitivity to melatonin or any excipients in the formulation should avoid use. Patients with uncontrolled epilepsy, severe depression, or those taking medications that may interact significantly (e.g., anticoagulants, CNS depressants) should consult a healthcare professional before starting therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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