Bipolar Disorder (BD) is a chronic mood disorder and mental health condition that causes extreme mood swings affecting energy levels, thinking, and behavior. These shifts can last days to months, making daily life difficult. 

The two most common forms of bipolar disorder are Bipolar I and Bipolar II. Bipolar I involves at least one full manic episode, which may or may not be accompanied by depression, while Bipolar II includes hypomania and at least one major depressive episode.

The pharmacological management of BD has three phases: (1) treating acute mania, (2) treating acute depression, and (3) maintenance therapy to prevent future episodes of mania or depression. Medications typically used to treat BD include mood stabilizers, second-generation antipsychotics, antidepressants, or an antidepressant-antipsychotic combination.

Surprisingly, there are not many current US-based guidelines for the pharmacological management of BD. The most recent updated guideline was published by the US Veterans Association and Department of Defense (VA/DoD) in September, 2023.

Since 2022, the Food and Drug Administration (FDA) has approved several expanded indications, new formulations, and delivery methods for medications used to manage BD. Additionally, a supplemental New Drug Application (sNDA) for risperidone is currently under review. 

Part 1 - Current Bipolar Disorder Guidelines

To start, here is a listing of the current Bipolar Disorder guideline:

Other guidelines that address treatment of BD in the context of mental health disorders and substance abuse are listed below:

Part 2 - Recent FDA Approvals

Below, are the recent medications and therapies recently approved by the FDA that we anticipate being incorporated into future US guidelines:

  • Igalmi (dexmedetomidine)
    • BioXcel Therapeutics
    • Approved April 6, 2022
    • IGALMI is now approved for the treatment of acute agitation associated with schizophrenia or bipolar disorder, and the only buccal/sublingual film approved for this indication. This alpha-2 adrenergic receptor agonist was previously indicated for sedation of ventilation patients.

  • Rykindo (risperidone)
    • Luye Pharma
    • Approved January 15, 2023
    • RYKINDO extended-release injection is approved for the treatment of schizophrenia in adults, and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. It acts as a dopamine (D2) and serotonin (5-HT2A) receptor antagonist.

  • Abilify Asimtufii (aripiprazole)
    • Otsuka/Lundbeck
    • Approved April 28, 2023
    • ABILIFY ASIMTUFII extended-release injectable is approved for the treatment of schizophrenia in adults, or for maintenance monotherapy treatment of bipolar I disorder in adults. It is a partial dopamine (D2) and serotonin (5-HT1A) agonist, as well as a serotonin (5-HT2A) receptor antagonist.

  • Fanapt (iloperidone)
    • Vanda Pharmaceuticals
    • Approved April 4, 2024
    • FANAPT, previously indicated for schizophrenia, has been approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. It comes in tablet form and acts as a dopamine (D2) and serotonin (5-HT2A) receptor antagonist.

  • Uzedy (risperidone)
    • Teva Pharmaceuticals
    • On February 25, 2025, the FDA accepted the sNDA for UZEDY for the maintenance treatment of bipolar I disorder in adults. The extended-release injection was approved in 2023 for schizophrenia, and works as an antagonist of dopamine (D2) and serotonin (5-HT2A) receptors.

Thank you for taking the time to review the current BD treatment guidelines, as well as the recent major changes and FDA approvals that have recently occurred. We value your feedback and would like to hear your suggestions for future topics to be covered in our guideline series. Please feel free to contact us with any ideas or questions you may have.

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