From the FDA Drug Label
As oral formulation for the: Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder Bipolar I Disorder (manic or mixed episodes) in adults (2.2) Oral: Start at 10 or 15 mg once daily Bipolar I Disorder (manic or mixed episodes) in adolescents (2.2) Oral: Start at 2. 5-5 mg once daily; Target: 10 mg/day
Dosage Guidelines for Mania:
- Adults: Start at 10 or 15 mg once daily
- Adolescents (ages 13-17): Start at 2.5-5 mg once daily, target 10 mg/day Key Points:
- Olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder
- Efficacy was established in clinical trials for both adults and adolescents 1
From the Research
The most effective treatment for managing acute bipolar mania is a stepwise approach starting with mood stabilizers or second-generation antipsychotics, with standard doses of lithium and aripiprazole associated with the lowest risk of relapse and non-psychiatric hospitalization, as shown in the most recent study from 2025 2.
Key Treatment Recommendations
- First-line treatments include lithium (600-1200 mg/day), valproate (750-1500 mg/day), or atypical antipsychotics like risperidone (2-6 mg/day), olanzapine (10-20 mg/day), quetiapine (400-800 mg/day), or aripiprazole (15-30 mg/day) 3, 4, 5.
- For severe mania, combination therapy with a mood stabilizer plus an antipsychotic is recommended, with lithium and aripiprazole being the most effective combination 2.
- Benzodiazepines like lorazepam (1-2 mg every 4-6 hours) may be added for agitation, but should be used with caution due to the risk of dependence and withdrawal 4.
Important Considerations
- Medication selection should account for patient-specific factors including previous response, side effect profile, and comorbidities 6, 5.
- Blood level monitoring is essential for lithium (target 0.8-1.2 mEq/L) and valproate (target 50-125 μg/mL) to minimize the risk of toxicity and ensure optimal efficacy 6, 2.
- Regular assessment of treatment response using standardized rating scales and monitoring for adverse effects is crucial throughout the treatment course to ensure the best possible outcomes for patients with bipolar disorder 3, 2.
Recent Evidence
- A 2025 study found that standard doses of lithium and aripiprazole were associated with the lowest risk of relapse and non-psychiatric hospitalization, making them the preferred treatment options for managing acute bipolar mania 2.
- The study also found that quetiapine was not associated with a decreased risk of relapse at any dose, and high doses of antipsychotics and mood stabilizers were associated with an increased risk of non-psychiatric hospitalization, highlighting the importance of careful dose selection and monitoring 2.