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Content Update

May 09, 2022

Lybalvi® Use in Patients with Bipolar I Disorder and Schizophrenia: Lybalvi® is a combination drug that contains olanzapine, a second-generation antipsychotic, and samidorphan, an opioid antagonist. It was U.S Food and Drug Administration approved in 2021 for the treatment of schizophrenia and for symptoms of psychosis associated with bipolar I disorder. Use of Lybalvi ® aims to increase medication adherence, treat and prevent metabolic comorbid conditions, and improve patient quality of life.



Upon completion of the chapter, the reader will be able to:

  1. Explain the pathophysiologic mechanisms underlying bipolar disorder.

  2. Recognize the symptoms of a manic episode in patients with bipolar disorder.

  3. Identify common psychiatric comorbidities of bipolar disorder.

  4. Recognize the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), criteria for bipolar disorder as well as the subtypes of bipolar I disorder, bipolar II disorder, and cyclothymic disorder.

  5. List the desired therapeutic outcomes for patients with bipolar disorder.

  6. Identify the optimal use of medications as first-line therapy in bipolar disorder, including appropriate dosing.

  7. Recommend drug therapy for acute treatment of mania and depressive episodes.

  8. Recommend baseline and routine monitoring for assessment of adverse effects of medications used in the treatment of bipolar disorder.

  9. Identify general treatment differences for agents used to treat bipolar disorder in the pediatric population.

  10. Explain why medication education is important for patients with bipolar disorder.


Bipolar disorder is characterized by one or more episodes of mania or hypomania, in addition to one or more major depressive episodes.1 It is chronic, with recurrent episodes and remissions. Mood episodes can be manic, hypomanic, or depressed, and each separated by periods of long stability or cycle rapidly. They occur with or without psychosis. Disability and other consequences (eg, increased risk of suicide) can be devastating to patients and families. Correct and early diagnosis and treatment are essential to prevent complications and maximize response to treatment.


The lifetime prevalence of bipolar I disorder and bipolar II disorder in the United States is estimated at approximately 1% and 1.1%, respectively. When including the entire spectrum of bipolar disorders, the prevalence is 2.4% worldwide.2 Bipolar I disorder affects men and women equally. Bipolar II, rapid cycling, and mixed mood features are more common in women.

The mean age of onset is 20 years, although onset may occur in early childhood to the mid-40s.1 If onset occurs after age 60, medical causes, such as thyroid dysfunction, electrolyte imbalances, or dementia should be ruled out as they can cause symptoms that mimic mania, hypomania, or depression. An early onset of bipolar disorder is associated with greater comorbidities, more mood episodes, a greater proportion of days ...

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