Zoloft (sertraline HCl)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved July 1997

Specific Treatments:

panic disorder

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General Information

The U.S. Food and Drug Administration cleared Pfizer to market Zoloft (sertraline HCl) for the treatment of panic disorder. Zoloft also received new labeling for maintaining antidepressant efficacy for up to 52 weeks in the treatment of depression. Zoloft was introduced for the treatment of depression in 1992 and, in 1996, for obsessive-compulsive disorder. The new clearance specifies that Zoloft may be marketed for the treatment of panic disorder, with or without agoraphobia.

Clinical Results

In clinical trials with adult patients, Zoloft demonstrated significant reduction in frequency of panic attacks without regard to age, gender or race. Patients suffering from panic disorder experience recurrent, unexpected panic attacks. The more common symptoms include heart palpitations, sensations of shortness of breath, dizziness and fear of losing control or going crazy. Panic attacks, or the fear of them, can also result in worry, concern or even dramatic behavioral and lifestyle changes.

Side Effects

The most common side effects were diarrhea, ejaculation failure, tremor, constipation, agitation, increased sweating, anorexia, and decreased libido.

Additional Information

Panic disorders is a disease which will afflict an estimated four to eight million American adults at some point in their lives. Agoraphobia is an incapacitating anxiety that can restrict people to their homes. Panic disorder is two to three times more prevalent among women. Onset occurs between late adolescence and the mid-30s.