DOZEPAT (FORMALLY SLEEPWELL TABLETS) TABLET (Each tablet contains Melalonin 5mg)

Indications

• Insomnia
• Jet lag
• Circadian rhythm sleep disorders
• Sleep disturbances in shift work
• Sleep disorders in children with developmental disorders

Dosage

Children: Refer to specific guidelines as doses may vary based on the condition being treated and the formulation used.

Adults: Refer to specific guidelines as doses may vary based on the condition being treated and the formulation used.

Mechanism of action

Melatonin acts on melatonin receptors, particularly MT1 and MT2, which are G-protein coupled receptors located in various tissues, including the brain. Activation of these receptors leads to the modulation of several physiological processes, including the promotion of sleep onset, regulation of circadian rhythms, and antioxidant effects. Melatonin also influences the release of other hormones, such as cortisol, which is involved in the sleep-wake cycle.

Pharmacodynamics

Melatonin exhibits a biphasic effect on sleep, promoting sleep initiation at low doses and potentially disrupting sleep at higher doses. Its sedative properties are characterized by a decrease in the time taken to fall asleep and an improvement in overall sleep quality. Melatonin also influences body temperature regulation and may have a role in immune function due to its antioxidant properties.

Pharmacokinetics

Melatonin is rapidly absorbed after oral administration, with peak plasma concentrations typically reached within 30 to 120 minutes. It has a short half-life, generally ranging from 20 to 50 minutes, which necessitates multiple dosing for sustained effects. Melatonin is metabolized primarily in the liver via cytochrome P450 enzymes, particularly CYP1A2, and cleared from the body mainly through urine. Its bioavailability can be affected by factors such as age, liver function, and concurrent medications.

Contra-indications

• Hypersensitivity to melatonin or any of its components
• Severe liver impairment
• Autoimmune diseases

Adverse effects

• Drowsiness
• Dizziness
• Headache
• Nausea
• Mood changes
• Vivid dreams or nightmares

Interactions

• CNS depressants (may enhance sedative effects)
• Anticoagulants (may affect bleeding risk)
• Immunosuppressants (may interfere with immune response)
• Hormonal medications (may influence hormonal balance)

Precautions

• Use with caution in individuals with depression or mood disorders
• May cause drowsiness; avoid activities requiring alertness after use
• Not recommended for long-term use without medical supervision
• Consult healthcare provider before use in patients with chronic conditions

Pregnancy

Limited data available, use only if clearly needed and prescribed by a healthcare provider.

Breast-feeding

Not recommended, as effects on breastfed infants are not well studied.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

• Tablets
• Capsules
• Liquid formulations
• Sublingual tablets