Compositions comprising alprazolam for treating primary insomnia and insomnia associate with anxiety states and process for preparing them

Abstract

Disclosed is a composition comprising alprazolam for treating primary insomnia and insomnia associated with anxiety states and the corresponding use and method comprising the administration of alprazolam sublingual tablets having a disintegration time lower than 30 seconds and having the alprazolam preferably in non-crystalline or partially crystalline form according to the X-ray diffraction crystallography expanded for the position delta 9-12.5 (2 theta), to a patient suffering from said disorder. There is also disclosed a method for preparing a composition according to the invention, where the alprazolam is solved in a pharmaceutical acceptable solvent and a binder, preferably polyvinylpyrrolidone, is incorporated to the solution. A pre-made mixture of part of the cross-linked carboxymethyl-cellulose and the rest of the ingredients of the composition is impregnated with the solution and is dried and grinded, and is added to the rest of the cross-linked carboxymethyl-cellulose and the flavoring additives, being then mixed and compressed.

Description

FIELD OF THE INVENTION[0001]The present invention refers to a method for treating patients suffering from primary insomnia and insomnia associated with anxiety states and a sublingual pharmaceutical composition containing alprazolam as the active principle useful for the treatment of primary insomnia and insomnia associated with anxiety states. The invention also describes the elaboration procedure of the composition and the features of the obtained sublingual or oral tablets. The invention further refers to the use of alprazolam and / or a composition comprising alprazolam for the manufacture of a medicament for the treatment of primary insomnia by sublingual administration.BACKGROUND ART[0002]Sleeping is a physiological process which is controlled by two biological processes, the homeostatic mechanism and the circadian rhythm. Most adults need about eight hours average of sleeping each night, on a regular basis, in order to feel rested and alert during the daytime. Any change in thi...

AI Technical Summary

Benefits of technology

[0030]Consequently, a major object of the present invention is to provide a pharmaceutical form for oral administration, preferably sublingual, of alprazolam, of rapid di

Problems solved by technology

Any change in this routine disrupts the delicate balance between two processes that interact to regulate sleeping.

This precludes the recovery that the body needs during the nighttime rest, the possible consequences being daytime somnolence, low concentration, tiredness and disability to feel active during the day.

A study by the National Sleep Foundation of the United States in 2002 reported that 74% of American adults experiment problems in sleeping several nights a week or more, 39% sleep less than seven hours per night and 37% exhibit somnolence during the daytime, thus interfering with their daily activities.

Despite that the consequences associated with chronic insomnia remain debatable, the following associations have been noted:increased risk of mortality is associated with short sleep lengths;insomnia is the best predictor of the future development of depression;catastrophic worry about the consequences of not sleeping is is common among patients with chronic insomnia and serves to maintain the sleep disturbance;increased risk exists of developing anxiety, alcohol and drug use disorders, and nicotine dependence;poor healt

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