The event: FDA approval decision for Intermezzo, a sleeping pill designed for people who wake up in the middle of the night.
The timeline: The FDA approval decision is expected on or before July 14.
The stakes: Intermezzo's active ingredient is the same as what's found in the popular sleeping pill Ambien although at a lower dose and formulated to dissolve easily under the tongue. What makes Intermezzo unique and somewhat risky is the proposed indication as the first-of-its-kind prescription sleep aid for people who wake in the middle of the night but cannot fall back to sleep. To get Intermezzo approved, Transcept must convince the FDA that the drug can be packaged and used correctly to reduce the risk of dosing errors or impaired next-day driving ability.