Skip Navigation

Advertise|Press|Contact|FAQ|About Us

Bookmark/Print/Share

Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Obstetrics/Gynecology (Women’s Health) | Psychiatry/Psychology

View By:YearCompanyConditionsTherapeutic AreasDrug Names

Zoloft (sertraline HCl)

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

Company: Pfizer
Approval Status: Approved May 2002
Treatment Area: Mood disorders

General Information

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.

Clinical Results

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.

Side Effects

Adverse events associated with the use of Zoloft may include (but are not limited to) the following:


  • Upset stomach
  • Trouble sleeping
  • Diarrhea
  • 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.

Additional Information

For additional information on Zoloft, please visit Zoloft.