Melatonin Xl Accord (Melatonin)

Melatonin acts on the melatonin receptor pathway to help normalize circadian rhythm disturbances.

• Jet lag: helps adjust the internal clock after rapid travel across time zones, facilitating quicker sleep onset at the new destination.
• Delayed sleep phase disorder: promotes earlier sleep onset by advancing the circadian phase in individuals with late‑night sleep patterns.
• Insomnia in adults: supports falling asleep and maintaining sleep continuity when difficulty initiating or sustaining sleep is present.

• Melatonin binds to MT1 and MT2 receptors in the suprachiasmatic nucleus, mimicking the endogenous hormone released at night. This agonist activity modulates the circadian pacemaker, signaling darkness and promoting physiological processes that favor sleep initiation and maintenance, thereby aligning the internal clock with the external light‑dark cycle.

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

Common Side Effects

• Drowsiness
• Headache
• Dizziness
• Nausea
• Mild gastrointestinal discomfort
• Vivid dreams

Serious or Rare Side Effects

• Allergic reaction (rash, itching, swelling, or difficulty breathing)
• Severe hypotension or blood pressure fluctuations
• Mood alterations such as depression or agitation
• Hormonal disturbances affecting reproductive function
• Rare cases of seizures in predisposed individuals

When considering melatonin therapy, several safety measures should be observed.

• Pregnancy: safety not established; consult a healthcare professional before use.
• Breastfeeding: unknown effects; weigh potential benefits against risks.
• Concomitant CNS depressants: may increase sedation; monitor patient response.
• Patients with autoimmune disorders: monitor for symptom changes as melatonin can modulate immune activity.
• Elderly: start with the lowest effective dose due to increased sensitivity.
• Store at ambient temperature: keep in the original container, protect from moisture and light.

Melatonin may interact with other medicines; awareness of the interaction level is important.

Major Interactions (Avoid)

• Anticoagulants (e.g., warfarin): melatonin may enhance anticoagulant effect, increasing bleeding risk.
• Immunosuppressants (e.g., cyclosporine): possible reduction in immunosuppressive efficacy.
• CYP1A2 inhibitors (e.g., fluvoxamine): may raise melatonin plasma concentrations, leading to heightened effects.

Moderate Interactions (Monitor Closely)

• CNS depressants (e.g., benzodiazepines): additive sedation may occur.
• Antihypertensives: potential additive lowering of blood pressure.
• Oral contraceptives: melatonin may alter hormone metabolism, affecting contraceptive reliability.