The US Food and Drug Administration (FDA) has approved Transcept Pharmaceuticals’ Intermezzo (zolpidem tartrate) C-IV, used to treat insomnia.

Intermezzo is available in doses of 1.75mg and 3.5mg as a sublingual tablet that contains a bicarbonate-carbonate buffer.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

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

Clinical Trials Arena Excellence Awards - Nominations Closed

Nominations are now closed for the Clinical Trials Arena Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Recognised with 2025 Excellence Awards for Research and Development and Marketing , Novotech converted FDA/EMA fast track designations into faster HDV trial timelines while translating complex HBV science into sponsor ready insights. Discover how this dual strength in execution and communication is reshaping liver disease clinical development.

Discover the Impact