Product image of Melatonin Xl Teva (Melatonin) supplied by GNH India

Melatonin Xl Teva

Active Ingredient:
Melatonin
Origin:
EU

Melatonin Xl Teva (Melatonin)

Melatonin, the active ingredient in Melatonin XL Teva, is a melatonin receptor agonist presented as an oral dosage form for oral use. It is indicated for the management of insomnia and other sleep‑onset difficulties in adults.
GNH India supplies Melatonin XL Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Teva Uk Limited

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Indications & Clinical Uses

Melatonin XL Teva is a melatonin receptor agonist used to address sleep‑wake cycle disorders.

  • Insomnia: helps patients fall asleep more quickly and improve sleep continuity.
  • Sleep onset difficulties: reduces the time required to initiate sleep.
  • Circadian rhythm sleep disorder: assists in aligning the internal clock with desired sleep‑wake times.

How It Works

  • Melatonin XL Teva acts as an agonist at melatonin MT1 and MT2 receptors located in the suprachiasmatic nucleus. Activation of these G‑protein‑coupled receptors modulates the circadian rhythm, promoting the physiological signaling that initiates sleep and helps synchronize the sleep‑wake cycle.

Side Effects

Melatonin XL Teva may cause a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Headache: mild to moderate pain often occurring after the first dose.
  • Dizziness: a sensation of light‑headedness, usually short‑lived.
  • Daytime sleepiness: residual drowsiness after nighttime use.
  • Nausea: mild gastrointestinal upset.
  • Irritability: temporary mood changes.
  • Mild abdominal discomfort: occasional stomach cramps.

Serious or Rare Side Effects

  • Allergic reactions: rash, itching, or swelling that may indicate hypersensitivity.
  • Severe dizziness or fainting: may require medical evaluation.
  • Mood alterations: depression or anxiety exacerbation.
  • Hallucinations or vivid dreams: uncommon but reported.
  • Severe hypotension: marked drop in blood pressure.
  • Anaphylaxis: rare life‑threatening allergic response.

Precautions & Warnings

When prescribing Melatonin XL Teva, clinicians should consider several safety measures.

  • Assess sleep disorder: confirm diagnosis before initiating therapy.
  • Use lowest effective dose: start with the smallest dose that provides benefit.
  • Avoid concurrent sedatives: co‑administration with CNS depressants may increase sedation.
  • Caution in hepatic impairment: liver dysfunction can alter melatonin metabolism.
  • Pediatric use: limit to children only when specifically indicated by a prescriber.
  • Store at room temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Melatonin XL Teva can interact with other medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin): may increase bleeding risk.
  • Immunosuppressants (e.g., cyclosporine): melatonin may reduce their efficacy.
  • Central nervous system depressants (e.g., benzodiazepines): additive sedation.

Moderate Interactions (Monitor Closely)

  • Oral contraceptives: melatonin may diminish contraceptive effectiveness.
  • Antidepressants (e.g., SSRIs): potential for increased side‑effects such as dizziness.
  • Antihypertensives: possible additive hypotensive effect.

Frequently Asked Questions

Melatonin XL Teva is a prescription melatonin receptor agonist indicated for the short‑term treatment of insomnia and other sleep‑onset difficulties in adults. It helps regulate the circadian rhythm, making it easier to fall asleep and maintain a more regular sleep pattern.

Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus of the brain, the central clock that controls circadian rhythms. Activation of these receptors signals the body that it is nighttime, promoting physiological processes that facilitate sleep onset and alignment of the sleep‑wake cycle.

The appropriate dose of Melatonin XL Teva is determined by the prescribing clinician based on the patient’s specific condition, age, and response to therapy. Dosage may vary, and patients should follow the prescriber’s instructions without self‑adjusting the amount.

Safety data for melatonin use in pregnancy and lactation are limited. Healthcare providers should weigh potential benefits against unknown risks before prescribing it to pregnant or nursing individuals. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternatives with their clinician.

To request Melatonin XL Teva, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, confirming trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.

Unlike benzodiazepines or non‑benzodiazepine hypnotics, melatonin works by mimicking the body’s natural hormone rather than depressing the central nervous system. This mechanism generally results in fewer next‑day residual effects, but efficacy may be limited to sleep‑onset problems rather than maintaining sleep throughout the night.

Melatonin XL Teva should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing it in bathrooms or other humid environments.

Melatonin XL Teva is taken orally, typically once daily in the evening, about 30 minutes before the intended bedtime. The tablet should be swallowed whole with water and not crushed or chewed, unless the prescriber provides specific instructions to do otherwise.

Serious risks, though rare, include severe allergic reactions such as rash, swelling, or anaphylaxis, and significant mood changes like depression or anxiety. Patients experiencing these symptoms should seek immediate medical attention and discontinue the medication.

Melatonin XL Teva is contraindicated in individuals with known hypersensitivity to melatonin or any excipients in the formulation. It should also be avoided in patients taking certain medications that have major interactions, such as anticoagulants, immunosuppressants, or CNS depressants, unless closely supervised by a healthcare professional.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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