FDA-Approved Medications for Bipolar Maintenance Treatment
For maintenance treatment of bipolar I disorder, the FDA has approved lithium, aripiprazole, olanzapine, quetiapine (as adjunct to lithium or valproate), and lamotrigine (in adults). 1, 2, 3, 4, 5
FDA-Approved Monotherapy Options
Lithium is FDA-approved for both acute mania and maintenance therapy in patients age 12 and older, representing the longest-standing approval for bipolar maintenance treatment 4
Aripiprazole is FDA-approved as monotherapy for maintenance treatment of bipolar I disorder, with efficacy demonstrated in preventing both manic and depressive relapses in patients who were stabilized on aripiprazole during the acute phase 1
Olanzapine is FDA-approved for maintenance treatment of bipolar I disorder as monotherapy, making it the only atypical antipsychotic besides aripiprazole with this specific monotherapy maintenance indication 3, 6
Lamotrigine is FDA-approved for maintenance therapy in adults with bipolar I disorder, significantly delaying time to intervention for any mood episode, though it is not indicated for acute manic episodes 4, 5
FDA-Approved Adjunctive Therapy Options
Quetiapine is FDA-approved for maintenance treatment of bipolar I disorder specifically as adjunct to lithium or divalproex, with efficacy established in two maintenance trials 2
Aripiprazole also has FDA approval for adjunctive maintenance therapy when combined with lithium or valproate, in addition to its monotherapy indication 1
Important Clinical Distinctions
The FDA has not approved quetiapine as monotherapy for maintenance treatment of bipolar disorder, despite its approval as adjunctive therapy—this is a critical distinction in prescribing 2
While multiple atypical antipsychotics (risperidone, ziprasidone) are FDA-approved for acute mania, they do not have FDA approval for maintenance treatment 5, 7
Valproate and carbamazepine, despite widespread use in clinical practice for maintenance, do not have specific FDA approval for bipolar maintenance treatment, though they are approved for acute mania 4
Age-Specific Considerations
For adolescents (age 12 and older), lithium remains the only FDA-approved agent with both acute and maintenance indications for bipolar disorder 4
Lamotrigine's maintenance approval is specifically for adults, and it should not be used for acute manic episodes in any age group 4, 5
Critical Prescribing Caveat
Most maintenance trials used enrichment designs, meaning patients were stabilized on the study medication during the acute phase before randomization—this means FDA approval often reflects continuation of effective acute treatment rather than switching to a new agent for maintenance 8
Withdrawal of maintenance lithium therapy is associated with relapse rates exceeding 90% in noncompliant patients versus 37.5% in compliant patients, emphasizing the importance of continuous treatment 4