Vraylar (Cariprazine) for Bipolar I Disorder
Vraylar (cariprazine) is an FDA-approved atypical antipsychotic that is effective for both acute manic/mixed episodes and depressive episodes associated with bipolar I disorder in adults. 1
Indications for Bipolar I Disorder
Vraylar is specifically indicated for:
- Acute treatment of manic or mixed episodes
- Treatment of depressive episodes (bipolar depression)
Dosing and Administration
- For manic/mixed episodes: 3-12 mg once daily
- For bipolar depression: 1.5-3 mg once daily 2
- Take once daily with or without food
- Do not abruptly discontinue treatment
Efficacy Profile
- Manic/Mixed Episodes: Clinical trials demonstrate significant reduction in Young Mania Rating Scale (YMRS) scores compared to placebo, with response rates of 48% vs 25% for placebo 3
- Bipolar Depression: Effective as monotherapy for acute bipolar depression at lower doses (1.5-3 mg/day) 2, 4
- Unique Feature: One of few medications effective across the entire bipolar I spectrum from depression to mania 5
Safety and Monitoring
Common Side Effects
- Akathisia (22% vs 6% placebo)
- Extrapyramidal symptoms (16% vs 1% placebo)
- Headache
- Constipation
- Nausea
- Dyspepsia 3, 6
Metabolic Considerations
- Monitor fasting glucose (may cause increases)
- Weight gain is relatively modest (mean change 0.54kg vs 0.17kg for placebo)
- Less than 3% of patients experience ≥7% weight gain 6
Required Monitoring
- Baseline and periodic monitoring of:
- Body mass index (monthly for 3 months, then quarterly)
- Blood pressure, fasting glucose, and lipids (at 3 months and then yearly)
- Extrapyramidal symptoms and tardive dyskinesia 1
Important Warnings
- Increased mortality risk in elderly patients with dementia-related psychosis (not approved for this population)
- Increased risk of suicidal thoughts and behaviors, especially in young adults and during dose changes
- May cause drowsiness affecting ability to drive or operate machinery
- Risk of overheating and dehydration (avoid excessive exercise and sun exposure) 1
Special Populations
- Pregnancy: May cause fetal harm; third trimester use may cause extrapyramidal and/or withdrawal symptoms in newborns
- Breastfeeding: Unknown if it passes into breast milk; discuss risks and benefits
- Elderly: Not approved for elderly patients with dementia-related psychosis due to increased mortality risk 1
Clinical Pearls
- Cariprazine has a unique pharmacological profile as a D3-preferring dopamine D2/D3 partial agonist, which may contribute to its efficacy across the bipolar spectrum 2
- May be particularly beneficial for patients who experience both manic and depressive episodes
- Lower doses (1.5-3 mg) are effective for bipolar depression, while higher doses (3-12 mg) are needed for mania 2, 3
- Consider as part of a comprehensive treatment approach that includes psychosocial interventions 7
Vraylar represents an important treatment option for bipolar I disorder with the advantage of efficacy across both poles of the illness, though careful monitoring for akathisia and metabolic effects is essential for optimal outcomes.