Transcept's Insomnia Therapy Wins FDA Approval

The approval is backed by two placebo-controlled studies which evaluated the safety and efficacy of Intermezzo for the treatment of patients with insomnia.

The US FDA has approved Transcept Pharmaceuticals' Intermezzo (zolpidem tartrate) C-IV for the treatment of insomnia.

The approval is backed by two placebo-controlled studies which evaluated the safety and efficacy of Intermezzo for the treatment of patients with insomnia.

Intermezzo is available in doses of 1.75mg and 3.5mg as a sublingual tablet that contains a bicarbonate-carbonate buffer. Women are recommended to take the 1.75mg dosage, while the 3.5mg is intended for men, as because women clear zolpidem from the body at a slower rate, the company said.