The COVID-19 pandemic has contributed to a significant increase in the rates of Americans living with mental illness.1 Meanwhile, medication shortages and a chronic scarcity of mental health professionals added pressure to an already stressed system.2 In this context, pharma companies play a vital role in developing novel therapies for mental health conditions, which can help alleviate the burden on healthcare providers and improve patient outcomes. As a clinical nurse practitioner who treats patients with a variety of mental health conditions, including bipolar 1 disorder, I believe innovative mental health strategies and treatment options, such as Lybalvi for bipolar 1 disorder, need to be considered across the healthcare spectrum.

Bipolar 1 treatment challenges

It is common for patients living with bipolar 1 disorder to be misdiagnosed with, and receive treatment for, major depressive disorder. Furthermore, up to one-third of patients can remain misdiagnosed for ten or more years. The consequences of misdiagnoses can adversely affect health outcomes due to delayed, ineffective or inappropriate treatments.3 And even once the condition is accurately diagnosed, bipolar 1 disorder can be difficult to treat due to the complexity of the symptoms and varied disease presentations.4 As a result, patients often must go through a trial and error period, in which they try several medications before finding one that works.5

The symptoms of bipolar 1 disorder can also make it difficult for some patients to take their medication as prescribed, making nonadherence a challenge for some people living with the disease. Evidence suggests approximately 50% of bipolar patients do not take their treatment as prescribed.6 Furthermore, in an expert consensus survey, 45% of providers reported they were “only somewhat confident” and another 33% said they were “not very confident” in assessing bipolar patients’ adherence to oral medication.7

Rethinking the concept of medication nonadherence

I believe that we, as providers, need to approach the notion of medication nonadherence differently. When we label people as “nonadherent,” we place too much blame on the patient. My experience has shown me that multiple factors contribute to a person not taking their medication as prescribed. For example, I have found many of my patients struggle with medications because they may not adequately control their symptoms. Others have told me their medications come with intolerable side effects. Often, it is a combination of both, so the process of finding the right treatment regimen means balancing efficacy, safety, and tolerability.

Treating side effects as a primary concern

One of the concerns I often hear from patients living with bipolar 1 disorder is the impact of side effects on their treatment experience. While efficacy should certainly be a priority, some providers consider side effects to be a secondary concern; however, I believe they should be just as important when considering treatment options. There are a variety of common side effects associated with bipolar 1 medications, with increased appetite, changes in metabolism, and weight gain being the most commonly reported.8 In an online survey, patients living with bipolar disorder highlighted weight gain during the initial three months of therapy as the side effect most likely to impact their adherence to bipolar medications.6

I believe weight gain holds significance as it can impact patients’ self-esteem and potentially contribute to metabolic disease over time. I have also found that while some medicines, like olanzapine, provide strong symptom control, the weight gain patients often experience has led some to discontinue use. More recently, for appropriate patients, I have begun to consider Lybalvi (olanzapine and samidorphan), which was approved in 2021.

Lybalvi indications include bipolar 1 disorder

Lybalvi is indicated for the treatment of adults with schizophrenia or bipolar 1 disorder for acute treatment of manic or mixed episodes as monotherapy and as an adjunct to lithium or valproate or as a maintenance monotherapy treatment. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lybalvi is not approved for the treatment of patients with dementia-related psychosis.7

I typically consider Lybalvi as a viable treatment option for patients who need symptom control, aren’t achieving the desired effectiveness with their current treatments, and may be concerned about side effects like weight gain. In some patients for whom I have prescribed Lybalvi, including some who have tried olanzapine alone in the past, I have seen an improvement in their bipolar I symptoms with fewer unwanted side effects.

Partnering with patients and caregivers for better outcomes

Preventing misdiagnosis and properly identifying bipolar I disorder early is essential for appropriate treatment.3 However, I believe that is only part of the solution. I think we must have more productive conversations with patients and their support systems about their goals and concerns regarding treatment early in the treatment journey and then at regular touchpoints along that journey. During these conversations, we should aim to educate them about the disease, what is happening in their brains and bodies, and the benefits and drawbacks of the different treatment options available.

As mental health treatment continues to evolve, newer medicines present opportunities to offer patients more treatment options to consider. I believe appropriate treatment options may also facilitate the patient’s participation in lifestyle changes or their desire to do so—this could include engaging in the appropriate therapeutic modality, nutritional awareness, or the addition of appropriate supportive measures. I have found that early collaboration is invaluable in determining a course of action for a patient living with bipolar I disorder. Creating an environment of open communication and trust where patients feel comfortable sharing their experiences and what’s working or not is essential to helping my patients do well long term.

Roger Rivera, DNP, is a board-certified family nurse practitioner (FNP), psychiatric–mental health nurse practitioner (PMHNP), and Trauma Surgery first Assist. His areas of expertise include psychiatry, critical care, emergency medicine, and trauma surgery. He holds a Nurse Educator Certification from the University of Florida and is enthused with teaching the art and science of integrative psychiatric care, especially with the experience incurred in the various specialties.

References

  1. Mental health during the COVID-19 pandemic. National Institutes of Health. Updated March 20, 2023. Accessed May 19, 2023.
  2. FDA Drug Shortages. U.S. Food & Drug Administration. Accessed May 19, 2023.
  3. McIntyre RS, Laliberté F, Germain G, et al. The real-world health resource use and costs of misdiagnosing bipolar I disorder. J Affect Disord. 2022;316:26-33.
  4. Bipolar Disorder. National Alliance on Mental Illness.
  5. Bipolar disorder. Mayo Clinic.