Melatonin-Valerosolv Teva Gyógyszergyár Zrt (Melatonin)

• Melatonin is a melatonin receptor agonist used to address disorders of the sleep‑wake cycle.
• Insomnia: helps initiate and maintain sleep in individuals with difficulty falling asleep.
• Sleep‑wake rhythm disorders: assists in normalising disrupted circadian rhythms.
• Delayed sleep phase syndrome: advances sleep onset to align with desired bedtime.

• Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking endogenous melatonin. This activation modulates the circadian clock, reduces neuronal firing in wake‑promoting areas, and facilitates the transition to sleep, thereby promoting sleep onset and improving sleep quality.

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

Common Side Effects

• Headache: mild to moderate pain often resolving without intervention.
• Dizziness: transient sensation of light‑headedness.
• Daytime sleepiness: residual drowsiness after nighttime dosing.
• Nausea: occasional gastrointestinal discomfort.
• Mild gastrointestinal upset: includes abdominal cramps or loose stools.

Serious or Rare Side Effects

• Allergic reactions: rash, itching, or swelling of the face, lips, or tongue.
• Severe rash: including Stevens‑Johnson syndrome.
• Mood changes: depression or agitation in susceptible individuals.
• Hallucinations: visual or auditory disturbances.
• Severe hypotension: marked drop in blood pressure leading to faintness.

Melatonin should be used with consideration of individual health status and potential interactions.

• Assess renal function: adjust use in patients with severe renal impairment.
• Avoid concurrent CNS depressants: increased risk of excessive sedation.
• Caution in shift‑work or jet‑lag situations: timing of administration is critical.
• Pregnancy and breastfeeding: consult a healthcare professional before use.
• Store at ambient temperature: keep in the original container, protect from moisture and light.

Melatonin may interact with other medications, requiring monitoring.

Major Interactions (Avoid)

• CNS depressants (e.g., benzodiazepines, alcohol): additive sedative effect.
• Anticoagulants (e.g., warfarin): potential increase in bleeding risk.

Moderate Interactions (Monitor Closely)

• Antidepressants (e.g., fluoxetine): may alter melatonin metabolism.
• Caffeine: can diminish melatonin’s sleep‑promoting effect.
• Beta‑blockers: may reduce endogenous melatonin levels.
• Antihistamines: may increase drowsiness when combined.