Purdue presented data from a double-blind, placebo-controlled, cross-over pharmacokinetic study in healthy volunteers of Intermezzo (zolpidem tartrate sublingual tablets) in doses of 1mg, 1.75mg, and 3.5mg. Treatment was administered on two consecutive days to 11 women and 13 men. At the same dose, the plasma levels of zolpidem tartrate in women were approximately 45% higher than in men. The study found that women taking a 3.5mg dose cleared the drug at a slower rate than men taking 3.5 mg (2.7mL/min/kg vs. 4mL/min/kg, respectively).
These findings support the recommendation that women should receive a lower dose of Intermezzo 1.75mg and that men should receive a higher dose of 3.5mg as per the FDA-approved labeling. Intermezzo 1.75mg is recommended dose for men and women ≥65 years of age.
Intermezzo is an imidazopyridine hypnotic indicated for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep, and when the patient has >4 hours of bedtime remaining.
For more information call (888) 726-7535 or visit www.intermezzorx.com.