The Medical Letter on Drugs and Therapeutics
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Low-Dose Sublingual Zolpidem (Intermezzo) for Insomnia due to Middle-of-the-Night Awakening

The FDA has approved a new low-dose sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem tartrate (Intermezzo – Transcept/Purdue) for treatment of insomnia due to middle-of-the-night awakening. Ambien and other zolpidem formulations available in the US are labeled for use only at bedtime.

PHARMACOKINETICS — A daytime study in 24 normal volunteers found that within 20 minutes after administration, both doses (1.75 and 3.5 mg) of the new formulation produced plasma concentrations >20 ng/mL, the level associated with sedation, and maintained that level for up to 4 hours. Serum concentrations reached a maximum in 37 minutes (Tmax). The half-life was 2.4 hours, and at 12 hours the drug was no longer detectable in plasma.1 According to the manufacturer, peak serum concentrations (Cmax) and the area under the time-concentration curve (AUC) are ... more      

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