On November 23, 2011, the FDA has approved the first drug indicated for use in treating early wakening, a form of insomnia which contains middle-of-the-night wakening with difficulty returning to sleep. The FDA cautions that the drug should only be used when there are at least 4 hours of bedtime remaining. Intermezzo, to be manufactured by Transcept Pharmaceuticals Inc., contains the prescription drug zolpidem tartrate as its active ingredient, to be administered as sublingual tablets. The recommended and maximum doses of this new formulation are 1.75 mg for women and 3.5 mg for men, taken once per night. Variance in dosage between men and women is because of slower metabolic clearance of the drug observed in women.
Zolpidem tartrate is a short-acting, nonbenzodiazepine hypnotic of the imidazopyridine class that potentiates GABA, an inhibitory neurotransmitter, by binding to GABA A receptors at the same location as benzodiazepines. Traditional zolpidem preparations work quickly (usually within 15 minutes) and have a short half-life (2–3 hours). It is reasonable to surmise that compared to the oral administration of traditional tablets of zolpidem tartrate, the sublingual delivery method by Intermezzo tablets may result in a faster onset of action. Adverse effects listed for Intermezzo mirror those of all other zolpidem medications, and therefore the same drug-drug interactions exist and the same precautionary measures should be observed.
Zolpidem tartrate was originally approved in the United States in 1992 as Ambien for the short-term treatment of insomnia as well as some brain disorders. Ambien is available in 5 mg and 10 mg tablets. Ambien CR, an extended release delivery method of zolpidem, is available in 6.25 mg and 12.5 mg tablets, consisting of a quick dissolving outer layer and a slower dissolving interior for a sustained release effect. While the Ambien brand may be among the most popular and well-known, zolpidem is marketed under numerous additional trade names.