Dosulepin Other names: Dothiepin

Treatment with dosulepin should be avoided during pregnancy unless there are compelling reasons. There is inadequate evidence of the safety of the drug during human pregnancy.

There is evidence that dosulepin is secreted in breast milk but this is at levels which are unlikely to cause problems.

Initially, dosulepin may impair alertness. Patients likely to drive or operate machinery should be warned of this possibility.

The following adverse effects, although not necessarily all reported with dosulepin, have occurred with other tricyclic antidepressants:

Atripine-like side effects including dry mouth, disturbance of accommodation, constipation, hesitancy of micturition and sedation are common early in treatment, but usually lessen.

Dizziness is also a common side effect of tricyclic antidepressants.

Uncommon adverse effects include drowsiness, sweating, postural hypotension, tremor skin rashes, tachycardia, confusion and hallucinations. Interference with sexual function may occur.

Potentially serious adverse effects are rare. These include depression of the bone marrow, agranulocytosis, hepatitis (including altered liver function), cholestatic jaundice, convulsions and inappropriate ADH secretion.

Psychotic manifestations, including mania and paranoid delusions, may be exacerbated during treatment with tricyclic antidepressants.

Cases of suicidal ideation and suicidal behaviours have been reported during dosulepin therapy or early after treatment discontinuation.

Withdrawal symptoms may occur on abrupt cessation of tricyclic therapy and include insomnia, irritability and excessive perspiration. Similar symptoms in neonates whose mothers received tricyclic antidepressants during the third trimester have also been reported.

Cardiac arrhythmias and severe hypotension are likely to occur with high dosage or in deliberate overdosage. They may also occur in patients with pre-existing heart disease taking normal dosage.

Class effects

Epidemiological studies, mainly in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to the risk is unknown.