trazodone hydrochloride: clinical use

Prescribing considerations

• Licensing differs by formulation: confirm the indication against the specific product.
• Not recommended for people under 18 because safety data are insufficient and antidepressant-associated suicidal behaviour and hostility are concerns.
• Use particular caution with epilepsy, bipolar or psychotic illness, cardiovascular disease, hyperthyroidism, severe hepatic or renal impairment, glaucoma, urinary problems and risk factors for hyponatraemia.
• Older or frail people are more susceptible to somnolence, orthostatic hypotension and additive effects from psychotropics or antihypertensives.
• Avoid abrupt withdrawal because nausea, headache and malaise can occur.

Contraindications and cautions

• Hypersensitivity to trazodone or product excipients
• Acute myocardial infarction
• Alcohol intoxication
• Intoxication with hypnotic medicines
• Product-specific excipient contraindications, including certain hereditary disorders of galactose metabolism for lactose-containing tablets or capsules

Monitoring

• Clinical worsening, suicidal thoughts and behavioural change, especially early in treatment and after treatment changes
• Sedation, falls, blood pressure and orthostatic symptoms
• Liver function when clinically indicated, particularly with hepatic impairment or symptoms of liver injury
• Electrolytes when symptoms suggest hyponatraemia
• ECG and cardiac risk where cardiovascular disease, QT prolongation or interacting medicines are present
• Full blood count if fever, sore throat or influenza-like symptoms suggest a blood dyscrasia
• Newborn withdrawal symptoms following exposure near delivery

Clinical pharmacology

Trazodone is a triazolopyridine antidepressant with serotonin-related and alpha-adrenolytic effects. It is rapidly absorbed, extensively hepatically metabolised, with CYP3A4 contributing to formation of the active metabolite m-chlorophenylpiperazine, and is eliminated mainly as urinary metabolites.

Formulation and product differences

• The selected film-coated tablet contains lactose and has a score line permitting division into equal halves.
• The selected capsule contains lactose and colourants including Sunset Yellow and Carmoisine.
• Selected oral solutions include different concentrations; verify the bottle and measuring device because volumes are not interchangeable.
• Liquid excipients vary and may include sorbitol, glycerol, benzoates, parabens, propylene glycol or small amounts of ethanol.
• The selected sugar-free oral solution contains sorbitol and preservatives and has product-specific storage and after-opening requirements.

Capsule

Route: Oral

Strengths: 50 mg, 100 mg

Oral solution

Route: Oral

Strengths: 50 mg/5 mL, 100 mg/5 mL