Sertindole: safety and tolerability profile.

Sertindole is a novel generation or atypical antipsychotic drug that has recently been re-introduced to the market. The safety and tolerability profile of sertindole have demonstrated a positive benefit/risk ratio in clinical trials and post-marketing studies. The number of patients who experienced extrapyramidal symptoms (EPS) while taking sertindole in clinical trials was similar to that of patients on placebo, and significantly less than that of patients on haloperidol. The relative lack of EPS is probably the result of the drug's highly selective blockade of limbic dopamine D 2 receptors and its lack of effect on other dopamine D 2 receptors, but may be due to low occupancy at dopamine D 2 striatal receptors. Sertindole also has a high affinity for serotonin 5-HT 2 and &#102 1 receptors. It has been shown not to cause sedation and its propensity to cause anticholinergic side effects is low, probably due to its lack of antihistamine and antimuscarinic activity. Sertindole does not cause any clinically significant changes in serum prolactin levels. QT interval prolongation does occur in some patients. The sertindole mortality rate is comparable to that of both risperidone and olanzapine (1.46, 1.75 and 1.20, respectively). Overall, sertindole is a well-tolerated drug that does not cause EPS, sedation or hyperprolactinaemia.