Melatonin Colonis Pharma (Melatonin)

• Melatonin acts on melatonin receptors to regulate the sleep‑wake cycle and is indicated for several sleep‑related conditions.
• Insomnia: helps initiate and maintain sleep in individuals with difficulty falling asleep.
• Sleep onset difficulties: reduces the time required to fall asleep.
• Jet lag: assists in adjusting circadian rhythm after rapid time‑zone travel.

• Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking endogenous melatonin. This activation synchronizes the circadian clock, lowers core body temperature, and promotes the physiological processes that facilitate sleep onset and maintenance.

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

Common Side Effects

• Headache: mild to moderate pain often resolves without intervention.
• Dizziness: transient sensation of light‑headedness.
• Daytime sleepiness: occasional residual drowsiness after nighttime use.
• Nausea: mild gastrointestinal discomfort.
• Vivid dreams: unusual or intense dreaming patterns.

Serious or Rare Side Effects

• Allergic reaction: rash, itching, swelling, or difficulty breathing.
• Depression: worsening mood or depressive symptoms.
• Severe daytime drowsiness: excessive sleepiness affecting daily activities.
• Hallucinations: visual or auditory disturbances.
• Seizures: rare occurrence of convulsive episodes.

• Melatonin should be used with consideration of individual health status and potential interactions.
• Medical supervision: use under guidance of a healthcare professional.
• Pediatric use: avoid unless specifically prescribed for a child.
• Operating machinery: refrain from driving or using heavy equipment if drowsy.
• Liver impairment: dose adjustment may be required in hepatic disease.
• Concurrent sedatives: monitor for additive sleep‑inducing effects.
• Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Melatonin can interact with several medications; awareness of the interaction level helps manage risk.

Major Interactions (Avoid)

• Warfarin: may increase anticoagulant effect.
• Fluvoxamine: can raise melatonin plasma concentrations.
• Carbamazepine: may reduce melatonin effectiveness.

Moderate Interactions (Monitor Closely)

• Caffeine: may diminish sleep‑promoting action.
• Alcohol: can enhance sedative effects.
• Antihypertensives: possible additive blood‑pressure lowering.
• Oral contraceptives: may alter hormone metabolism.
• NSAIDs: potential for increased gastrointestinal irritation.