Zoloft Indications and Dosage

Zoloft (Sertraline) Indications and Dosage

anxiety
depression
obsessive-compulsive disorder (OCD)
panic disorder
posttraumatic stress disorder (PTSD)
premature ejaculation _†
premenstrual dysphoric disorder (PMDD)
social phobia (social anxiety disorder)

_† non-FDA-approved indication

Sertraline Indications and Dosage

For the treatment of major depression; also for the treatment of inconsolable crying _† or aggression/irritability following stroke or brain injury:

NOTE: Acute episodes require several months of sustained drug therapy. SSRIs are effective for up to 1 year. Maintain on lowest effective dosage; periodically reassess to determine the need for continued treatment.

Oral dosage:
Adults and the elderly: 50 mg PO once daily. A lower initial dose may be used (e.g., 25 mg) to minimize adverse effects. If necessary, increase at intervals of not less than one week up to 200 mg/day.
Adolescents _† : Preliminary data suggest sertraline is effective. To minimize adverse effects, initially 25—50 mg PO once daily. Titrate weekly as needed up to 200 mg/day PO. In one study, thirteen adolescents hospitalized for a major depressive episode received a mean dosage of 110 mg/day PO or 1.96 mg/kg/day PO. At 12 weeks, Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale scores were significantly decreased from baseline.
Children 6—12 years _† : Initially, 25 mg PO once daily. If needed, increase by 25—50 mg/week, as tolerated, up to 200 mg/day.

For the treatment of anxiety disorders:
NOTE: Anxiety disorders are often chronic conditions; consider continuation of sertraline in patients demonstrating a therapeutic response. Maintain therapy at the lowest effective dosage and periodically reassess to determine the need for continued treatment.

for general anxiety disorder (GAD) _† :

Oral dosage:
Adults: Initial dose of 25 mg PO once daily. After one week, increase dose to 50 mg PO once daily. If necessary, increase by 50 mg/day at intervals of not less than one week up to 200 mg/day.
Children >= 5 years and adolescents: Initial dose of 25 mg PO once daily. After one week, increase dose to 50 mg PO once daily. In placebo-controlled trials, 50 mg/day was the maximum dose evaluated.

for social phobia (social anxiety disorder):
Adults: Initial dose of 25 mg PO once daily. After one week, increase dose to 50 mg PO once daily. If necessary, increase by 50 mg/day at intervals of not less than one week up to 200 mg/day. In a double-blind crossover study, a statistically significant improvement in scores on the Liebowitz Social Anxiety Scale was found with sertraline after 10 weeks but not with placebo. In a 20-week study, a relative response rate of 24% was achieved (ranked as ‘much improved’ or ‘very much improved’ on the Clinical Global Impression scale) versus placebo. In a follow-up 24-week study to assess relapse rates, 4% of patients in the sertraline group experienced a relapse versus 36% of those switched to placebo.

for obsessive-compulsive disorder (OCD):
NOTE: OCD is a chronic condition; consider continuation of sertraline in a responding patient. Maintain on the lowest effective dosage and periodically reassess to determine the need for continued treatment.

Oral dosage:
Adults and adolescents: Initially, 50 mg PO once daily. If necessary, increase at intervals of not less than one week up to 200 mg/day.
Children 6—12 years: Initially, 25 mg PO once daily. Increase by 25—50 mg/week, as tolerated and needed, up to 200 mg/day.
Children < 6 years: Safe and effective use has not been established.

for panic disorder (with or without agoraphobia) or posttraumatic stress disorder (PTSD), including the long-term treatment of PTSD:
NOTE: Panic disorder and PTSD are chronic conditions; consider continuation of sertraline in a responding patient. Maintain on the lowest effective dosage and periodically reassess to determine the need for continued treatment.

Oral dosage:
Adults: Initially, 25 mg PO once daily. After one week, increase dose to 50 mg PO once daily. If necessary, increase by 50 mg/day at intervals of not less than one week up to 200 mg/day. In the treatment of PTSD, sertraline has been effective for a wide variety of traumatic stressors, including combat.

For the treatment of premature ejaculation _† :
Oral dosage:
Adult males: Men with lifelong rapid ejaculation (i.e., an intravaginal ejaculation latency time of <= 1 minute) received sertraline, another SSRI, or placebo for 6 weeks. Mean intravaginal ejaculation latency time (IELT) with placebo was 20 seconds; the IELT in men treated with sertraline 50 mg/day PO increased to about 110 seconds in this one study.

For the treatment of premenstrual dysphoric disorder (PMDD) according to the criteria of the DSM-IV:
Oral dosage:
Adult females: 50—150 mg PO once daily. Initiate at 50 mg/day PO for the first cycle, then titrate upward if needed. One study of 242 women demonstrated that sertraline was superior to placebo in controlling PMDD. Sixty-two percent of women receiving sertraline had at least 30% improvement from baseline versus only 34% of women receiving placebo. The mean effective dosage was 100 mg/day. Alternatively, cyclic luteal phase administration (i.e., 14 days prior to menses) has been effective for some women.

Maximum Dosage Limits:

Adults: 200 mg/day PO.
Elderly: 200 mg/day PO; however, lower dosages may be effective/better tolerated.
Adolescents: 200 mg/day PO.
Children >= 6 years: 200 mg/day PO; however, lower dosages may be effective/better tolerated.
Children < 6 years: safe and effective use has not been established.

Patients with hepatic impairment:
Dosage should be modified depending on clinical response and degree of hepatic impairment, but no quantitative recommendations are available. Lower doses or less frequent dosing intervals may be needed, particularly in patients with cirrhosis.

Patients with renal impairment:
No dosage adjustments are needed.

Intermittent hemodialysis:
No dosage adjustments are needed. Sertraline is unlikely to be significantly removed by hemodialysis given its large volume of distribution.

_† non-FDA-approved indication

[ Last revised: 9/23/2005 2:10:00 PM ]

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