Maximum Recommended Dose of Quetiapine (Seroquel)
The maximum recommended dose of quetiapine (Seroquel) is 750 mg per day for most indications, as specified in the FDA drug labeling. 1
Approved Maximum Dosages by Indication
- Schizophrenia in Adults: Maximum 750 mg/day 1
- Schizophrenia in Adolescents (13-17 years): Maximum 800 mg/day 1
- Bipolar Mania in Adults: Maximum 800 mg/day 1
- Bipolar Mania in Children/Adolescents (10-17 years): Maximum 600 mg/day 1
- Bipolar Depression in Adults: Maximum 300 mg/day 1
- Bipolar I Disorder Maintenance in Adults: Maximum 800 mg/day 1
Dosing Considerations
- Initial dosing should be lower with gradual titration to minimize side effects such as orthostatic hypotension and sedation 2
- For most indications, quetiapine is typically started at 25-50 mg twice daily and gradually increased based on clinical response and tolerability 1
- Elderly patients should start at lower doses (50 mg/day) with more cautious titration in increments of 50 mg/day 1
- Patients with hepatic impairment should start at 25 mg/day with careful titration in increments of 25-50 mg/day 1
Administration Guidelines
- Quetiapine can be taken with or without food 1
- For most indications, the total daily dose can be divided into two or three doses per day 1, 3
- For bipolar depression, administration is recommended once daily at bedtime 1
Monitoring and Safety
- Monitor for orthostatic hypotension, especially during initial dose titration 2
- Exercise caution when using with other CNS depressants due to potential additive effects 2
- Avoid rapid dose decreases or abrupt discontinuation which can produce withdrawal symptoms 2
- No routine blood monitoring is required, unlike some other antipsychotics 4
Special Populations
- For elderly patients: Start at 50 mg/day with slower titration 1
- For hepatically impaired patients: Start at 25 mg/day with careful titration 1
- Quetiapine is not recommended during pregnancy or nursing 2
Clinical Efficacy Considerations
- Clinical trials have demonstrated that doses between 150-750 mg/day are effective for schizophrenia 4, 5
- Fixed-dose studies suggest that dosages of 150-450 mg/day are as effective as higher doses for many patients 5
- Despite some clinical practice trends toward "high-dose" therapy (>800 mg/day), robust controlled data strongly support that the standard dosage range (up to 750 mg/day) is appropriate for most clinical use 5
While some clinicians may prescribe doses higher than the FDA-approved maximum in certain treatment-resistant cases, this practice is not supported by strong clinical evidence and should be approached with caution due to potential increased risk of side effects.