Many psychiatrists have long prescribed a number of antidepressants, along with psychological therapy, to treat post-traumatic stress, an anxiety disorder that can result after a life-threatening or otherwise traumatic experience such as combat, rape, assault or natural disaster.
But the Food and Drug Administration's approval Tuesday means manufacturer Pfizer Inc. can advertise Zoloft for such treatment, potentially widening use.
Symptoms of post-traumatic stress include flashbacks, nightmares, persistently avoiding reminders of the event, survivor guilt, insomnia and depression.
When the FDA looked separately at men and women in the two successful studies, only the women showed a benefit.
The lack of evidence that Zoloft helps men does not prove that it could never work for them, the FDA said, so the agency decided to merely mention in Zoloft's label the gender question, rather than restricting the drug's use to women.