LYBALVI (olanzapine and samidorphan) contains olanzapine, which has been proven to reduce manic or mixed episodes of bipolar 1 disorder in adults
In one study, half of the adults taking one of the ingredients of LYBALVI, olanzapine, went 59 days without relapse or hospitalization versus 23 days for half of the adults who took a placebo (sugar pill).
Half of the patients taking olanzapine went
without relapse or hospitalization vs half of the patients taking placebo (sugar pill)
In this study, patients with manic or mixed episodes of bipolar 1 disorder who had responded to olanzapine for 2 weeks were continued on olanzapine or placebo (sugar pill) and observed for relapse. 225 patients received olanzapine and 136 patients received placebo. Relapse was defined as an increase in symptoms on 2 standard surveys, or being hospitalized for either mania or depression.
The most common side effects of LYBALVI when used alone to treat people with mixed or manic episodes that happen with bipolar 1 disorder include:
- dry mouth
- increased appetite
LYBALVI can help reduce bipolar 1 disorder symptoms as measured by the Young Mania Rating Scale (Y-MRS), one of the most frequently used rating scales to assess manic symptoms.Symptoms measured by Y-MRS
LYBALVI can be used for the treatment of manic or mixed episodes of bipolar 1 disorder in adults:
together with lithium
as a maintenance therapy, meaning it can be used every day to help reduce symptoms on an ongoing basis
Take LYBALVI exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking LYBALVI yourself.
Do not take LYBALVI if you are taking opioids or are experiencing acute opioid withdrawal.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you:
- take opioids or have stopped taking opioids in the past 14 days
- take or plan to take other olanzapine containing medicines
LYBALVI and other medicines may affect each other causing possible serious side effects. LYBALVI may affect the way other medications work, and other medicines may affect how LYBALVI works.
Your healthcare provider can tell you if it is safe to take LYBALVI with your other medicines. Do not start or stop any medicines while taking LYBALVI without talking to your doctor first.