Non-Oral Medication Options for Bipolar Disorder
Intramuscular aripiprazole is the primary non-oral medication available for bipolar disorder, specifically approved for acute agitation in bipolar I disorder (manic or mixed episodes), with rapid symptom control achieved within 2 hours of injection. 1, 2
FDA-Approved Intramuscular Formulation
Intramuscular aripiprazole (Abilify IM) is FDA-approved in the US for treatment of agitation associated with bipolar I disorder (manic or mixed episodes). 2
The intramuscular formulation demonstrates 98% absolute bioavailability, achieving 78% of peak plasma concentration within 0.5 hours post-injection, compared to only 5% with oral administration at the same timepoint. 1
The area under the curve in the first 2 hours is 90% higher after intramuscular administration compared to oral administration, providing significantly more rapid symptom control. 1
Intramuscular aripiprazole has been proven effective and generally well tolerated in large, well-designed trials for agitation associated with bipolar I disorder. 2
Dosing and Administration
The pharmacokinetic profile demonstrates linear dose proportionality across a range from 1 mg to 45 mg, supporting flexible dosing based on clinical need. 1
Intramuscular aripiprazole is associated with a low risk for extrapyramidal symptoms, cardiac effects, hyperprolactinemia, weight gain, and other metabolic disturbances. 2
Clinical Context and Limitations
This intramuscular formulation is specifically indicated for acute agitation management, not for maintenance therapy of bipolar disorder. 2
For long-term maintenance treatment of bipolar disorder, oral medications remain the standard of care, including lithium, valproate, lamotrigine, and oral atypical antipsychotics. 3, 4
The American Academy of Child and Adolescent Psychiatry recommends lithium, valproate, or atypical antipsychotics (including aripiprazole, olanzapine, risperidone, quetiapine, ziprasidone) for acute mania/mixed episodes, but these recommendations primarily refer to oral formulations for ongoing treatment. 3
Important Clinical Considerations
Intramuscular aripiprazole was noninferior to intramuscular haloperidol for agitation associated with schizophrenia and related disorders, but with a superior tolerability profile. 2
The favorable tolerability profile makes intramuscular aripiprazole a valuable treatment option when rapid control of agitation is needed in the emergency or inpatient setting. 2
After acute stabilization with intramuscular aripiprazole, transition to oral mood stabilizers or oral antipsychotics is necessary for ongoing bipolar disorder management. 3