Quoted from http://www.lvrj.com/news/fda-suicide-memo-revealed-in-wrongful-death-case-147424015.html
FDA suicide memo revealed in wrongful death case
By Carri Geer Thevenot
LAS VEGAS REVIEW-JOURNAL Posted: Apr. 14, 2012 | 2:00 a.m.
Updated: Apr. 14, 2012 | 10:23 p.m.
Relatives of a Hard Rock Hotel executive who killed himself two years ago have uncovered a 2006 memo from the Food and Drug Administration that examines possible links between sleep aids and suicide.
Lawyers representing the family of Randy Kwasniewski, who fatally shot himself in March 2010, recently filed the document as an exhibit in their wrongful death case against sanofi-aventis U.S. -- the company that makes the sleeping pill Ambien.
Also named as a defendant in the lawsuit is Nadine Leone, a marriage and family therapist who met with Kwasniewski five days before his death. The plaintiffs allege Leone knew Kwasniewski had been prescribed Ambien but failed to warn him about the possible mental and emotional effects of taking the drug.
In a recent motion, the plaintiffs' attorneys further addressed Leone's role. They mentioned the 2006 memo in a footnote to the motion and attached the memo as an exhibit.
"Of course, it is possible that Ms. Leone was unaware of the magnitude of the problem with Ambien and suicide," according to the footnote. "In a study obtained by plaintiffs per the Freedom of Information Act (and not available on the Internet), suicide with the use of Ambien was of such concern that the FDA ordered additional studies and warnings."
According to the memo, a systematic review of the FDA's adverse events reporting system, known as AERS, revealed multiple cases in which drugs used to treat insomnia had been linked to suicides or "suicidal ideation."
"A total of 71 cases were reviewed which reported suicidal thoughts, attempts, and completed suicides," according to the memo.
Of those, 49 involved zolpidem, the drug in Ambien.