FDA-Approved Medications for Bipolar Disorder
Acute Mania/Mixed Episodes
Lithium is FDA-approved for acute mania and maintenance therapy in patients age 12 and older, representing the only FDA-approved agent specifically for bipolar disorder in adolescents. 1, 2
Atypical Antipsychotics Approved for Acute Mania
- Aripiprazole - FDA-approved for acute mania in adults 1, 3
- Olanzapine - FDA-approved for acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as adjunct to lithium or valproate 4
- Risperidone - FDA-approved for acute mania in adults 1, 3
- Quetiapine - FDA-approved for acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as adjunct to lithium or divalproex 5, 6
- Ziprasidone - FDA-approved for acute mania in adults 1, 7
- Asenapine - FDA-approved for acute mania 8
- Cariprazine - FDA-approved for acute mania 8
Traditional Mood Stabilizers
- Valproate (Divalproex) - FDA-approved for acute mania in adults 3
Bipolar Depression
The olanzapine-fluoxetine combination is FDA-approved for the treatment of depressive episodes associated with bipolar I disorder. 4, 9
Additional FDA-Approved Options for Bipolar Depression
- Quetiapine - FDA-approved as monotherapy for acute treatment of depressive episodes associated with bipolar disorder 5, 9
- Lurasidone - FDA-approved as monotherapy and as adjunct to lithium or divalproex for bipolar depression 8, 9
Important caveat: Olanzapine monotherapy is NOT FDA-approved for treatment of depressive episodes associated with bipolar I disorder. 4
Maintenance Treatment
Lithium is FDA-approved for maintenance therapy in bipolar disorder, with superior evidence for long-term efficacy in preventing both manic and depressive episodes. 1, 2
Atypical Antipsychotics Approved for Maintenance
- Olanzapine - FDA-approved for maintenance treatment of bipolar I disorder 4
- Aripiprazole - FDA-approved for maintenance therapy 7
- Quetiapine - FDA-approved for maintenance treatment of bipolar I disorder as adjunct to lithium or divalproex 5
Anticonvulsants
- Lamotrigine - FDA-approved for maintenance therapy in adults with bipolar I disorder, particularly effective for preventing depressive episodes 1, 3
Acute Agitation
Olanzapine intramuscular is FDA-approved for treatment of acute agitation associated with schizophrenia and bipolar I mania. 4
Critical Clinical Considerations
- Antidepressant monotherapy is NOT FDA-approved and should be avoided due to risk of mood destabilization and triggering manic episodes 1, 2, 3
- When antidepressants are necessary for bipolar depression, they must always be combined with a mood stabilizer (lithium or valproate) 1, 3
- Haloperidol is FDA-approved for bipolar mania but should not be first-line due to inferior tolerability and higher extrapyramidal symptoms risk 1, 3