dosage form for the administration of an active ingredient for accelerated sleep induction and / or for the treatment of sleep disorders and / or to treat a central nervous system disorder

摘要

dosage form for the administration of an active ingredient for accelerated sleep induction and / or for the treatment of sleep disorders and / or for treating a central nervous system disorder a dosage form for oral administration through the membranes mucous membranes, an active ingredient for accelerated sleep induction and / or for the treatment of sleep disorders and / or for the treatment of a central nervous system disorder, said active ingredient being lipophilic or amphiphilic and in a dissolved state which It is stable and complete in a hydroalcoholic solution comprising 35% to 70% by weight of ethanol and 30% and 65% by weight of water, generating nanostructures of said active ingredient in the hydroalcoholic solution, thus allowing the active principle of crossing the blood-brain barrier, said active ingredient being in base and / or salt form and belonging to chemical families of sleep inducers or mod lipophilic or amphiphilic type and a molecular weight of less than 1000 da, said active ingredient being selected from the families of imidazopyridines, including zolpidem, the family of cyclopyrrolones, including eszopiclone, the family of pyrazolopyrimidines, including zaleplon, benzodiazepines family, including midazolam and brotizolam, the family of antihistamine-h1 sedatives including doxylamine and cyproheptadine, and / or the family of melatonin and melatonin agonists, including melatonin, ramelteon, and agomelatine, the volume of said hydroalcoholic solution being less than or equal to 2 ml, and said active ingredient being present at a dosage that is less than or equal to 8 mg, all of said active principle being transmucosally absorbed through the mucous membranes of the oral cavity floor , particularly through the gums / cheeks, through the gum area, through the cheeks, or under the tongue.