What it's for (Indications)
- Vortioxetine is an antidepressant used to treat major depressive disorder.
- The mechanism of its antidepressant effect is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT).
Dosage Information
| Type | Guideline |
|---|---|
| Standard | The recommended starting dose is 10 mg administered orally once daily, without regard to meals. The dose should then be increased to 20 mg/day, as tolerated. A dose decrease to 5 mg/day may be considered for patients who do not tolerate higher doses. For known CYP2D6 poor metabolizers, the maximum recommended dose is 10 mg/day. While vortioxetine can be discontinued abruptly, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible. |
Safety & Warnings
Common Side Effects
- Common adverse reactions (incidence ≥5% and at least twice the rate of placebo) include nausea, constipation, and vomiting.
- Other potential adverse reactions include hypersensitivity reactions, clinical worsening and suicide risk, serotonin syndrome, increased risk of bleeding, activation of mania/hypomania, discontinuation syndrome, angle closure glaucoma, and hyponatremia.
Serious Warnings
- Black Box Warning: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS. Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. TRINTELLIX is not approved for use in pediatric patients.
- Patients treated with antidepressants should be closely monitored for clinical worsening and for the emergence of suicidal thoughts and behaviors, especially in pediatric and young adult patients.
- Other significant warnings and precautions include the risk of Serotonin Syndrome (especially when used with other serotonergic drugs or MAOIs), increased risk of bleeding, activation of mania/hypomania, discontinuation syndrome upon abrupt cessation (especially at higher doses), angle closure glaucoma, and hyponatremia.
How it Works (Mechanism of Action)
The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine's antidepressant effect has not been established.