DESYREL is indicated for the treatment of depression. The efficacy of DESYREL has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association's Diagnostic and Statistical Manual, III.a

Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

The dosage should be initiated at a low level 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. DESYREL should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within two weeks. Twenty- five percent of those who respond to DESYREL require more than two weeks (up to four weeks) of drug administration.

Usual Adult Dosage

An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four 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.

Maintenance

Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

Although there has been no systematic evaluation of the efficacy of DESYREL beyond six weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.

DESYREL® (trazodone hydrochloride)

Tablets, 150 mg—orange, in the DividoseÒ tablet design (debossed with MJ and 778 on front; “50,” “50,” “50” on reverse)

NDC 0087-0778-43 Bottles of 100

Tablets, 300 mg—yellow, in the Dividose® tablet design (debossed with MJ and 796 on front; “100,” “100,” “100” on reverse)

NDC 0087-0796-41 Bottles of 100

Storage

Store at room temperature. Protect from temperatures above 104° F (40° C). Dispense in tight, light- resistant container (USP).

References

a. Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders-III, American Psychiatric Association May, 1980.
b. Lue TF, Physiology of erection and pathophysiology of impotence. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell's Urology. Sixth edition. Philadelphia: W.B. Saunders; 1992: 722-725.
c. Goldstein I, Krane RJ, Diagnosis and therapy of erectile dysfunction. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell's Urology. Sixth edition. Philadelphia: W.B. Saunders; 1992: 3071-3072.
d. Yealy DM, Hogya PT: Priapism. Emerg Med Clin North Am. 1988; 6:509-520.
e. Banos JE, Bosch F, Farre M, Drug- induced priapism. Its aetiology, incidence and treatment. Med Toxicol Adverse Drug Exp. 1989; 4:46-58.
f. O'Brien WM, O'Connor KP, Lynch JH. Priapism: current concepts. Ann Emerg Med. 1989: 980-983.
g. Bardin ED, Krieger JN. Pharmacological priapism: comparison of trazodone- and papaverine-associated cases. Int Urol Nephrol. 1990; 22:147-152.

Bristol-Myers Squibb Company
Princeton, NJ 08543-4500, USA
Revised January 2005
FDA rev date: 1/12/2005

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