Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Obstetrics/Gynecology (Women’s Health) | Psychiatry/Psychology
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Zoloft (sertraline HCl)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved May 2002
Treatment Area: Mood disorders
Zoloft has been approved for the treatment of Premenstrual
Dysphoric Mood Disorder (PMDD). It can be taken either daily or for
the two weeks before a woman's period. Zoloft is also indicated
for the treatment of depression, posttraumatic stress disorder,
panic disorder and obsessive-compulsive disorder.
PMDD exhibits symptoms similar to those seen with major
depressive disorder and other mood disorders, but is
distinguishable from such disorders by its cyclical nature. The
intense physical and emotion symptoms associated with PMDD are
present only between ovulation and menstruation. It is estimated
that three to five percent of American women suffer from PMDD.
The approval of Zoloft for the treatment of PMDD is supported by
two placebo-controlled trials involving 532 women diagnosed with
the disorder. Zoloft was significantly more effective in improving
emotional and behavioral symptoms of PMDD than placebo, regardless
if the drug was taken continously or only during the premenstrual
phase of the menstrual cycle. These symptoms included feelings of
being depressed, hopeless or overwhelmed, and being angry or
irritable and having conflicts with others. Those who were
admistered Zoloft every day also noted improvement in physical
symptoms including breast tenderness, bloating and headache.
Adverse events associated with the use of Zoloft may include
(but are not limited to) the following:
- Upset stomach
- Trouble sleeping
- Abdominal pain
- Dry mouth
- Sexual dysfunction
Mechanism of Action
Zoloft (sertraline HCl) is a selective serotonin reuptake
inhibitor. Zoloft helps correct the chemical imbalance of serotonin
in the brain. The effectiveness of Zoloft is presumed to be linked
to its inhibition of CNS neuronal uptake of serotonin (5HT).
Serotonin is a naturally occurring chemical in the brain that is
involved in the transmission of messages between nerve cells.
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