Europe — EMA
Orimelan (Melatonin)
GNH USA supplies Orimelan (Melatonin), a hormone for sleep regulation and insomnia, for adults with circadian rhythm disturbances. Request a quote for supply.
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What is Melatonin?
Melatonin, the active ingredient in Orimelan, is a hormone presented as an oral formulation for oral use. It plays a key role in synchronising circadian rhythms and is employed to promote the onset of sleep and improve sleep quality in individuals experiencing difficulty falling asleep or maintaining sleep, especially during periods of jet lag, shift work, or age‑related changes.
GNH USA supplies Orimelan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance, regulatory compliance and reliable global distribution across EU and other regulated markets.
What is Melatonin used for?
Melatonin is used as a sleep‑regulating agent to address disturbances in the circadian rhythm.
Insomnia: reduces the time needed to fall asleep and may improve overall sleep quality. Jet lag: helps adjust the internal clock to new time zones, facilitating quicker adaptation. Delayed sleep phase disorder: promotes earlier sleep onset for individuals with a shifted sleep schedule. Shift work disorder: supports better alignment of sleep patterns with irregular work hours.
What are the side effects of Melatonin?
Melatonin is generally well tolerated, but adverse reactions can occur.
Common Side Effects: - Drowsiness: feeling unusually sleepy during the day. - Headache: mild to moderate head pain. - Dizziness: sensation of light‑headedness. - Nausea: upset stomach or feeling sick. - Vivid dreams: unusually intense or memorable dreams. - Mood changes: mild irritability or anxiety.
Serious or Rare Side Effects: - Allergic reaction: rash, itching, swelling, or difficulty breathing. - Severe dizziness: may lead to falls or injury. - Hormonal effects: menstrual irregularities or changes in libido. - Mood disorders: depression or severe anxiety. - Cardiovascular events: rare cases of palpitations or hypertension. - Liver enzyme elevation: abnormal liver function tests.
What precautions apply to Melatonin?
When considering melatonin therapy, certain safety measures are recommended.
Pregnancy: consult a healthcare provider before use. Breastfeeding: discuss potential risks with a physician. Pediatric use: administer only under medical supervision. Anticoagulant therapy: monitor for increased bleeding tendency. Driving or operating machinery: avoid if drowsiness occurs. Store at room temperature: keep in the original container, protect from moisture and light.
What does Melatonin interact with?
Melatonin may interact with other medications, requiring attention to potential effects.
Major Interactions (Avoid): - Anticoagulants (e.g., warfarin): may increase bleeding risk. - Immunosuppressants (e.g., cyclosporine): possible reduction in immunosuppressive efficacy.
Moderate Interactions (Monitor Closely): - Central nervous system depressants (e.g., benzodiazepines): additive sedation. - Caffeine: may diminish melatonin's sleep‑promoting effect. - Oral contraceptives: potential alteration of hormone levels. - Antidepressants (e.g., SSRIs): may affect melatonin metabolism.



