Gepirone Dosage

Medically reviewed by Drugs.com. Last updated on May 6, 2025.

Usual Adult Dose for Major Depressive Disorder

INITIAL DOSE: 18.2 mg orally once a day

MAINTENANCE DOSE: Dosage titration should be based on clinical response and treatment tolerability.

• Day 4: May be increased to 36.3 mg orally once a day
• After Day 7: May be increased to 54.5 mg orally once a day
• After an additional week: May be increased to 72.6 mg orally once a day

MAXIMUM DOSE: 72.6 mg orally once a day

Comments:

• Electrolyte abnormalities should be corrected before starting therapy with this drug.
• Electrolytes should be monitored during dose titration and periodically during treatment in patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia.
• An ECG should be performed prior to initiating therapy, during dosage titration, and periodically during treatment.
• This treatment should not be started in patients with a QTc greater than 450 msec at baseline.
• Dosage should not be escalated if the QTcF (QTc by Fridericia's formula) is greater than 450 msec.
• It is recommended to assess patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with this drug.

Use: For the treatment of major depressive disorder

Usual Geriatric Dose for Major Depressive Disorder

INITIAL DOSE: 18.2 mg orally once a day

MAINTENANCE DOSE: Dosage titration should be based on clinical response and treatment tolerability.

• After Day 7: May increase dose to 36.3 mg orally once a day

MAXIMUM DOSE: 36.3 mg orally once a day

Comments:

• Electrolyte abnormalities should be corrected before starting therapy with this drug.
• Electrolytes should be monitored during dose titration and periodically during treatment in patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia.
• An ECG should be performed prior to initiating therapy, during dosage titration, and periodically during treatment.
• This treatment should not be started in patients with a QTc greater than 450 msec at baseline.
• Dosage should not be escalated if the QTcF (QTc by Fridericia's formula) is greater than 450 msec.
• It is recommended to assess patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with this drug.

Use: For the treatment of major depressive disorder

Renal Dose Adjustments

CrCl 50 mL/min or greater: No dose adjustment recommended

CrCl less than 50 mL/min:

• Initial dose (Day 1): 18.2 mg orally once a day
• Maintenance dose: Dosage titration should be based on clinical response and treatment tolerability.
• After Day 7: May be increased to 36.3 mg orally once a day
• Maximum dose: 36.3 mg orally once a day

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): No dose adjustment recommended

Moderate liver dysfunction (Child-Pugh B):

• Initial dose (Day 1): 18.2 mg orally once a day
• Maintenance dose: Dosage titration should be based on clinical response and treatment tolerability.
• After Day 7: May be increased to 36.3 mg orally once a day
• Maximum dose: 36.3 mg orally once a day

Severe liver dysfunction (Child-Pugh C): Contraindicated

Dose Adjustments

Dosage Modifications for Concomitant Use With CYP450 3A4 Inhibitors and Inducers:

• Moderate CYP450 3A4 inhibitors: Dose should be reduced by 50%
• Strong CYP450 3A4 inhibitors: Contraindicated
• Strong CYP450 3A4 inducers: Use should be avoided

Recommendations for Transitioning to or from a Monoamine Oxidase Inhibitor:

• At least 14 days must elapse between MAOI antidepressant discontinuation and initiation of therapy with this drug.
• Allow at least 14 days to elapse after discontinuing this drug prior to starting therapy with a MAOI antidepressant.

Precautions

US BOXED WARNING:

• SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. This drug is not approved for use in pediatric patients.

CONTRAINDICATIONS:

• Known hypersensitivity to the active component or any of the ingredients
• Prolonged QTc interval greater than 450 msec at baseline
• Congenital long QT syndrome
• Concomitant use of strong CYP450 34A inhibitors
• Severe hepatic impairment
• Taking, or within 14 days of stopping, a MAOI due to the risk of serious or possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome
• Initiation of this drug in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take this drug with food at approximately the same time each day.
• Swallow tablets whole; do not split, crush, or chew tablets.

Storage requirements:

• Store at 20C to 25C (68F to 77F).
• Excursions are permitted between 15C to 30C (59F to 86F).
• Protect from high humidity and moisture.

Monitoring:

• Cardiovascular: For elevated QT interval (at baseline, during titration, and periodically); monitor more frequently if this drug is used:
• Concomitantly with drugs known to prolong the QT interval
• In patients who develop a QTc of 450 msec or greater during treatment
• In patients with a significant risk of developing torsade de pointes
• Metabolic: For electrolyte abnormalities (at baseline and during treatment if indicated based on history or risk)

Psychiatric: For personal or family history of bipolar disorder, mania, or hypomania (at baseline)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Take this drug with food at approximately the same time every day.
• Seek medical attention if any symptoms of serotonin syndrome occur, especially with concomitant use of other antidepressants.
• Notify your health care provider immediately at the emergence of suicidal ideation and behavior, especially during early treatment or during dose adjustments.
• Report symptoms of feeling faint, loss of consciousness, or heart palpitations to your physician.
• Inform your health care provider of current or future medication use, including over-the-counter medications.
• Observe for signs of mania or hypomania activation and report any new symptoms to your provider.
• Patients of childbearing potential: Notify your health care provider of a known/suspected pregnancy; a pregnancy registry is available.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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