What is the maximum recommended dose of Zyprexa (olanzapine)?

Maximum Recommended Dose of Zyprexa (Olanzapine)

The maximum recommended dose of olanzapine (Zyprexa) is 20 mg/day for adults with schizophrenia or bipolar disorder. 1

Dosing Guidelines by Indication

Schizophrenia

• Adults:

  • Starting dose: 5-10 mg once daily
  • Target dose: 10 mg/day
  • Maximum dose: 20 mg/day 1
  • Maintenance treatment: 10-20 mg/day 1

• Adolescents:

  • Starting dose: 2.5-5 mg once daily
  • Target dose: 10 mg/day
  • Maximum dose: 20 mg/day 1

Bipolar I Disorder (Manic or Mixed Episodes)

• Adults:

  • Starting dose: 10-15 mg once daily
  • Effective dose range: 5-20 mg/day
  • Maximum dose: 20 mg/day 1

• Adolescents:

  • Starting dose: 2.5-5 mg once daily
  • Target dose: 10 mg/day
  • Maximum dose: 20 mg/day 1

Agitation Associated with Schizophrenia and Bipolar I Mania

• Intramuscular injection:
  • Recommended dose: 10 mg
  • Lower doses (5-7.5 mg) may be considered when clinically warranted
  • Maximum daily dose: 30 mg 1

Special Populations

Elderly Patients

• Lower starting doses (2.5-5 mg) are recommended 2
• Dose increases should be performed with caution 1

Patients with Dementia

• Starting dose: 2.5 mg once daily at bedtime
• Maximum dose: 10 mg once daily 2, 3
• Caution: FDA black box warning regarding increased mortality risk in elderly patients with dementia 3

Clinical Considerations

Efficacy at Higher Doses

While some research suggests that doses higher than 20 mg/day may be beneficial in treatment-resistant cases 4, 5, these doses exceed the FDA-approved maximum and should be approached with caution. A study examining olanzapine dosing practices found increasing use of doses exceeding 20 mg/day (up to 60 mg/day in some case reports), but the benefit-risk ratio at these higher doses remains uncertain 5.

Adverse Effects

The risk of adverse effects increases with higher doses:

• Weight gain
• Sedation
• Metabolic effects (particularly at doses >20 mg/day)
• Elevated prolactin levels at higher doses 5
• Extrapyramidal symptoms (though less common than with typical antipsychotics) 6

Monitoring

When using olanzapine, especially at higher doses, monitor for:

• Weight gain
• Metabolic parameters (glucose, lipids)
• Sedation
• Orthostatic hypotension
• QT prolongation
• Extrapyramidal symptoms 3

Important Caveats

• The safety and efficacy of doses above 20 mg/day have not been systematically evaluated in clinical trials 1
• Dose adjustments should generally occur at intervals of not less than 24 hours 1
• Olanzapine should be administered on a once-daily schedule, with or without food 1
• Regular reassessment is necessary to determine the continued need for maintenance treatment 1

While some clinicians may use higher doses in treatment-resistant cases, the FDA-approved maximum dose remains 20 mg/day, and exceeding this dose increases the risk of adverse effects without clear evidence of additional benefit for most patients.