What is the recommended initial dosage and treatment regimen for a patient starting Brintellix (vortioxetine)?

Brintellix (Vortioxetine) Prescribing Guidelines

The recommended starting dose of Brintellix is 10 mg once daily, which should then be increased to 20 mg daily as tolerated, as this higher dose provides significantly greater efficacy with similar tolerability. 1

Initial Dosing Strategy

• Start with 10 mg once daily taken orally without regard to meals 1
• Increase to 20 mg daily as the target therapeutic dose, as tolerated 1
• For patients who cannot tolerate higher doses, consider reducing to 5 mg daily 1

Rationale for 20 mg Target Dose

The 20 mg dose demonstrates clear superiority over lower doses:

• Significantly greater improvement in depressive symptoms compared to 10 mg (difference of -1.03 points on MADRS scale, P < .05) 2
• More rapid response: separates from placebo by week 2, whereas 10 mg does not separate until week 4 2
• Higher response rates: 51.4% achieve symptomatic response with 20 mg vs 46.0% with 10 mg (P < .05) 3
• More sustained response: 36.0% maintain response through 8 weeks with 20 mg vs 29.8% with 10 mg (P < .05) 3

Dose Titration Timing

In clinical practice, dose escalation occurs rapidly:

• 48% of patients are increased to 20 mg after just 1 week of treatment 2
• 64.3% of patients ultimately receive 20 mg as their final maintenance dose 2
• The tolerability profile remains similar between 10 mg and 20 mg doses 2

Special Populations

CYP2D6 poor metabolizers: Maximum recommended dose is 10 mg daily 1

Discontinuation Protocol

• Brintellix can be discontinued abruptly 1
• However, for doses of 15 mg or 20 mg daily, reduce to 10 mg for one week before full discontinuation if possible 1

Common Pitfalls to Avoid

• Do not remain at 10 mg indefinitely without attempting dose increase—nearly two-thirds of patients benefit from 20 mg 2
• Do not delay dose escalation beyond 1-2 weeks in patients tolerating initial dose—earlier escalation provides faster symptom relief 2, 3
• Do not use with MAOIs: contraindicated within 21 days of stopping vortioxetine or within 14 days of stopping an MAOI 1

Expected Adverse Effects

Most common side effects (≥5% incidence, at least twice placebo rate):

• Nausea 1
• Constipation 1
• Vomiting 1

These effects do not increase significantly when escalating from 10 mg to 20 mg 2

Efficacy Evidence

Vortioxetine demonstrates clear dose-response relationship:

• Response rate: 53.2% vs placebo 35.2% 4
• Remission rate: 29.2% vs placebo 19.3% 4
• Maintains superiority over placebo in long-term relapse prevention studies up to 52 weeks 4