Zoloft |
|
| Brand Name: | Zoloft |
| Active Ingredient: | sertraline hydrochloride |
| Indication: | Treatment of posttraumatic stress disorder; also indicated for depression, obsessive-compulsive disorder, and panic disorder |
| Company Name: | Pfizer Inc. |
| Availability: | This new indication was approved by FDA on December 7, 1999 |
Introduction
More than 100 million prescriptions for Pfizer’s Zoloft have been written since its launch in 1992, helping patients with depression, obsessive-compulsive disorder, and panic disorder. Now Zoloft is the first medication to be approved for treating post-traumatic stress disorder (PTSD), which may develop in an individual following any extreme traumatic event in which there was threatened death or serious injury, and the person’s response involved intense fear, helplessness, or horror. Such events may include physical and sexual abuse and natural disasters.
Some 50% of the general population is exposed to a traumatic event in their lifetimes, and 10% to 20% of those people develop PTSD. The disorder is twice as common in women as in men, and is associated with symptoms such as persistent intrusive thoughts of the event, flashbacks, overall emotional numbness, or being easily startled.
The recommended dose of Zoloft for PTSD is 25 mg once daily, with an increase up to 50 mg daily after the first week. Patients who don’t respond to a 50 mg dose may benefit from doses up to 200 mg per day.
How It Works
Zoloft belongs to the class of drugs that inhibit central nervous system neuronal uptake of serotonin. Studies show that Zoloft blocks the uptake of serotonin into human platelets.
Clinical Study Results
Zoloft’s effectiveness for treating symptoms of post-traumatic stress disorder is based on two multicenter placebo-controlled, 12-week trials in adults who were diagnosed with post-traumatic stress disorder. Zoloft was shown to improve PTSD symptoms as measured by the Clinician-Administered PTSD Scale, Impact of Event Scale, and Clinical Global Impressions. However, the overall positive outcome in these trials appeared to derive from the female patients, with little effect seen in the male subgroups. A study of Zoloft for PTSD in a Department of Veterans Affairs (VA) setting, where the patients were primarily males, as well as in another study in the general population both failed to show a statistically significant benefit from the drug. The importance of this apparent gender difference is unknown, and Pfizer has stated that it intends to study the gender discrepancy further in a long-term relapse prevention trial.
Other studies have shown that Zoloft is beneficial in patients with post-traumatic stress disorder and comorbid disorders, such as alcoholism or depression. In a VA study of 72 patients with PTSD and major depression, Zoloft and the drug fluoxetine each substantially improved symptoms in 50% of patients. Another study of 9 patients with PTSD and alcoholism showed that treatment with Zoloft improved PTSD symptoms, increased the number of days of abstinence from alcohol, and decreased the average number of drinks consumed during the follow-up period. In a third study, Zoloft was also shown to benefit 4 out of 5 women who developed post-traumatic stress disorder as a result of rape.
What the Patient Should Know
The most common side effects reported with use of Zoloft include nausea, insomnia, diarrhea, ejaculation problems, and somnolence. Patients should inform their healthcare providers about any other medications they may be taking, particularly monoamine oxidase inhibitors (MAOIs). Zoloft is contraindicated until at least 14 days have passed since discontinuing an MAOI, and an MAOI is contraindicated for at least 14 days after discontinuing Zoloft. An MAOI and Zoloft should never be taken together.