Agorest 25 mg (Tablet)

Indications

• Major depressive disorder especially in non-responders and intolerant to SSRIs
• Generalized anxiety disorder
• Bipolar depression
• Sleep disturbances
• Seasonal affective disorder
• Migraine and cluster headaches

Pharmacology

• Binds to melatoninergic receptors and serotoninergic 5-HT2c receptor
• MASSA (Melatonin Agonist and Selective Serotonin Antagonist) concept
• Stimulates activity of MT1 and MT2 receptors
• Normalizes circadian rhythms and disrupted sleep-wake cycles
• Does not inhibit the uptake of serotonin, norepinephrine, or dopamine
• Increases slow-wave sleep
• Potentially increases neurogenesis in the hippocampus
• May have neuroprotective effects

Dosage

25 mg per day given once at bedtime for two weeks; can be increased to 50 mg per day in patients with inadequate response

Administration

Oral administration with or without food; recommended nighttime dosing

Interaction

Metabolised mainly by cytochrome P450 1A2 (CYP1A2) and CYP2C9; potential interactions with inhibitors of these isoenzymes

Contraindications

• Hepatic impairment
• Hypersensitivity to active substances or excipients

Side Effects

• Headache
• Nausea
• Diarrhea

Pregnancy & Lactation

• No clinical data on exposed pregnancies available
• Caution prescribed to pregnant women
• Unknown excretion into human milk
• Discontinuation of breastfeeding if treatment is considered necessary

Precautions & Warnings

Increases level of liver enzymes; monitoring warranted before and during therapy

Use in Special Populations

• Children under 18 years - only under medical advice
• Not recommended for children and adolescents in the treatment of depression
• Limited clinical data in elderly patients (65 years)

Overdose Effects

• Limited experience with overdose
• Signs and symptoms include drowsiness and epigastralgia
• No specific antidotes known; treatment of clinical symptoms and routine monitoring recommended

Therapeutic Class

Atypical anti-depressant drugs

Storage Conditions

Store in a cool and dry place away from light; keep out of the reach of children

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