What are the FDA (Food and Drug Administration) approved medications for treating mania in bipolar disorder?

FDA-Approved Medications for Treating Mania in Bipolar Disorder

The FDA-approved medications for treating mania in bipolar disorder include lithium, valproate, and atypical antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine, and ziprasidone). 1, 2

First-Line Medications for Acute Mania

Mood Stabilizers

• Lithium is FDA-approved for the treatment of acute manic episodes and maintenance therapy in bipolar disorder 3
• Valproate is FDA-approved for acute mania in adults and is particularly effective for mixed or dysphoric subtypes of mania 2

Atypical Antipsychotics

• Aripiprazole is FDA-approved for acute manic and mixed episodes in bipolar I disorder 2
• Olanzapine is FDA-approved for acute mania and maintenance therapy 2
• Risperidone is FDA-approved for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder, both as monotherapy and as adjunctive therapy with lithium or valproate 4
• Quetiapine is FDA-approved for acute manic episodes 1, 2
• Ziprasidone is FDA-approved for acute mania 1, 2

Combination Therapy Options

• Risperidone adjunctive therapy with lithium or valproate is specifically FDA-approved for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder 4
• Combination therapy with lithium or valproate plus an atypical antipsychotic is recommended for severe or treatment-resistant mania 2

Treatment Selection Algorithm

1. For mild to moderate mania: Start with monotherapy using lithium, valproate, or an atypical antipsychotic 1, 2
2. For severe mania: Consider combination therapy with lithium or valproate plus an atypical antipsychotic 2
3. For mixed episodes: Valproate may be preferred over lithium 2
4. For rapid symptom control: Atypical antipsychotics may provide more rapid symptom control than mood stabilizers alone 1

Efficacy Considerations

• Lithium typically produces normalization of manic symptoms within 1-3 weeks 3
• Response rates for lithium in acute mania range from 38-62% 1
• Valproate shows higher response rates (53%) compared to lithium (38%) in some studies 1
• Atypical antipsychotics have demonstrated efficacy across a broader range of symptoms than typical antipsychotics 5

Important Clinical Considerations

• Antidepressants should be discontinued during manic episodes as they can worsen symptoms 1, 2
• Regular monitoring of medication levels is required for lithium therapy 2
• Atypical antipsychotics require careful monitoring for metabolic side effects, particularly weight gain 1
• For maintenance therapy after acute mania, the regimen that effectively treated the acute episode should be continued for at least 12-24 months 1

Treatment-Resistant Mania

• For treatment-resistant cases, clozapine may be considered, though it is not FDA-approved specifically for mania 2, 6
• Electroconvulsive therapy (ECT) may be effective in treatment-refractory cases 6

Common Pitfalls to Avoid

• Using antidepressant monotherapy, which can trigger manic episodes or rapid cycling 1, 2
• Inadequate duration of maintenance therapy, leading to high relapse rates 1
• Failure to monitor for metabolic side effects of atypical antipsychotics 1
• Premature discontinuation of medication, as more than 90% of noncompliant patients relapse 1