a melatonin receptor agonist and a selective serotonin- receptor antagonist

Indications: treatment of major depressive disorder.

Cautions: bipolar disorder, mania or hypomania; concomitant use of drugs associated with hepatic injury; excessive alcohol consumption; obesity; diabetes; non-alcoholic fatty liver disease; dose adjustment may be necessary if smoking started or stopped during treatment.

Hepatotoxicity

Hepatic injury, including hepatitis and hepatic failure reported rarely; test liver function before treatment and after 3, 6, 12 and 24 weeks of treatment, and then as appropriate (restart monitoring schedule if dose increased); discontinue if serum transaminases exceed 3 times the upper limit of reference range or symptoms of liver disorder.

Contra-indications: dementia; patients over 75 years of age; see also Hepatotoxicity above.

Hepatic impairment: avoid, renal impairment caution in moderate to severe impairment,

Pregnancy: manufacturer advises avoid.

Breast-feeding: avoid—present in milk in animal studies.

Side Effects: nausea, vomiting, diarrhoea, constipation, abdominal pain, increased serum transaminases (see Hepatoxicity above), headache, dizziness, drowsiness, agitation, sleep disturbances, fatigue, anxiety, back pain, sweating; less commonly paraesthesia, restless legs syndrome, blurred vision, tinnitus, eczema; rarely hepatitis, hepatic failure (see Hepatotoxicity above), weight changes, rash; suicidal behaviour) and pruritus also reported.

Dose: ADULT over 18 years, 25 mg at bedtime, increased if necessary after 2 weeks to 50 mg at bedtime.