Dose Selection

An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.

The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.

Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Important Administration Instructions

DESYREL® can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.

DESYREL should be taken shortly after a meal or light snack.

Screen for Bipolar Disorder Prior to Starting DESYREL

Prior to initiating treatment with DESYREL or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.7)].

Switching to or from Monoamine Oxidase Inhibitor Antidepressant

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of DESYREL. In addition, at least 14 days must elapse after stopping DESYREL before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].

Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers

Discontinuation of Treatment with DESYREL

Adverse reactions may occur upon discontinuation of DESYREL [See Warnings and Precautions (5.8)]. Gradually reduce the dosage rather than stopping DESYREL abruptly whenever possible.