Rankings / Mood, Anxiety & Stress
Olanzapine + samidorphan (Lybalvi)
Mood, Anxiety & Stress · Antipsychotic + opioid antagonist
Tier B-
High-risk evidence profile
Bottom line
Read Off Label grades Olanzapine + samidorphan (Lybalvi) as B- (6.0/10) based on strong evidence, med-high benefit magnitude, and a med-high-risk safety profile.
Its high-risk evidence profile reflects a Safety score of 3.5/10; reported benefits and harms can differ by indication, dose, route, duration, and population.
Alkermes (Lybalvi).
Studied, labeled, or reported-use context: Oral once daily (olanzapine 5-20 mg + samidorphan 10 mg) — Rx; not individualized guidance.
What the evidence says
Alkermes (Lybalvi). FDA-approved for schizophrenia and bipolar I. Samidorphan attenuated olanzapine-associated weight gain in registration trials (ENLIGHTEN-2); the open question is whether the metabolic-mitigation signal holds in real-world use. Industry-sponsored.
Mechanism
Fixed-dose olanzapine plus the opioid antagonist samidorphan, designed to retain olanzapine efficacy while blunting its characteristic weight gain via central opioid-receptor blockade.
Studied, labeled, or reported dose & route
Oral once daily (olanzapine 5-20 mg + samidorphan 10 mg)
This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.
Citations
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Common questions
- What does the evidence show about Olanzapine + samidorphan (Lybalvi)'s effects?
- Read Off Label rates the evidence for Olanzapine + samidorphan (Lybalvi) as Strong and the benefit magnitude as med-high, producing an overall grade of B- (6.0/10). Alkermes (Lybalvi).
- What safety findings are reported for Olanzapine + samidorphan (Lybalvi)?
- Olanzapine + samidorphan (Lybalvi) has a med-high risk profile in the database. Med-High (olanzapine metabolic/sedation burden only partly mitigated; antipsychotic-class warnings) Legal status: Rx (FDA-approved: schizophrenia, bipolar I).
- What does the low Safety score for Olanzapine + samidorphan (Lybalvi) represent?
- The Safety score is 3.5/10. It records the substantial harms described for one or more use contexts; the Benefit score, indication, dose, route, duration, population, and legal status remain separate parts of the evidence profile.
- What doses or routes are reported for Olanzapine + samidorphan (Lybalvi)?
- Oral once daily (olanzapine 5-20 mg + samidorphan 10 mg) This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
- How does Olanzapine + samidorphan (Lybalvi) work?
- Fixed-dose olanzapine plus the opioid antagonist samidorphan, designed to retain olanzapine efficacy while blunting its characteristic weight gain via central opioid-receptor blockade.
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.