Major Depressive Disorder-ZOLOFT® (sertraline hydrocMoride) is indicated for the treatment of major depressive disorder.

The efficacy of ZOLOFT in the treatment of a major depressive episode was established in six to eight week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLFNICAL PHARMACOLOGY).

A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The antidepressant action of ZOLOFT in hospitalized depressed patients has not been adeÄ?uately studied.

The efficacy of ZOLOFT in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving ZOLOFT for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).

Obsessive-Compulsive Disorder-ZOLOFT is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of ZOLOFT was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY).

Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

The efficacy of ZOLOFT in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking ZOLOFT and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLFNICAL PHARMACOLOGY). Nevertheless, the physician who elects to use ZOLOFT for extended periods should periodically re-evaluate the long-term usefulness of the daig for the individual patient (see DOSAGÄ? AND ADMINISTRATION).

Panic Disorder-ZOLOFT is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-TV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or conseÄ?uences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of ZOLOFT was established in three 10-12 week trials in panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY).

Panic disorder (DSM-TV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or morÄ?) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart ratÄ?; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

The efficacy of ZOLOFT in maintaining a response, in patients with panic disorder who responded during a 52-week treatment phase while taking ZOLOFT and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLFNICAL PHARMACOLOGY). Nevertheless, the physician who elects to use ZOLOFT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMFNISTRATION).

Posttraumatic Stress Disorder (PTSD)-ZOLOFT (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder.

The efficacy of ZOLOFT in the treatment of PTSD was established in two 12-week placebo-controlled trials of outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLFNICAL PHARMACOLOGY).

PTSD, as defined by DSM-III-R/TV, reÄ?uires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of generaÅ? responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted rangÄ? of affect, or sense of foreshortened futurÄ?; and symptoms of autonomie arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis reÄ?uires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

The efficacy of ZOLOFT in maintaining a response in patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use ZOLOFT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMFNISTRATION).

Premenstrual Dysphoric Disorder (PMDD) - ZOLOFT is indicated for the treatment of premenstrual dysphoric disorder (PMDD).

The efficacy of ZOLOFT in the treatment of PMDD was established in 2 placebo-controlled trials of female outpatients treated for 3 menstrual cycles who met criteria for the DSM-in-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY).

The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms oceur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant.

The effectiveness of ZOLOFT in long-term use, that is, for morÄ? than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use ZOLOFT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMFNISTRATION).

Social Anxiety Disorder - ZOLOFT (sertraline hydrochloride) is indicated for the treatment of social anxiety disorder, also known as social phobia.

The efficacy of ZOLOFT in the treatment of social anxiety disorder was established in two placebo-controlled trials of outpatients with a diagnosis of social anxiety disorder as defined by DSM-EV criteria (see Clinical Trials under CLFNICAL PHARMACOLOGY).

Social anxiety disorder, as defined by DSM-EV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress.

The efficacy of ZOLOFT in maintaining a response in patients with social anxiety disorder for up to 24 weeks following 20 weeks of ZOLOFT treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe ZOLOFT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLFNICAL PHARMACOLOGY).