Abstract: Methods for treating obsessions and/or compulsions are described. In one method, ondansetron or a pharmaceutically acceptable salt thereof is administered to a patient suffering from obsessions and/or compulsions for more than seven days. The ondansetron or pharmaceutically acceptable salt thereof may be administered as a pharmaceutically effective dose up to about 1.5 mg (free-base equivalent). In another method, a serotonin reuptake inhibitor (SRI) and ondansetron or a pharmaceutically acceptable salt thereof is administered to a patient suffering from obsessions and/or compulsions. The method may optionally include the step of administering a serotonin reuptake inhibitor to the patient. Additionally or alternatively, the method may also include the step of administering a neuroleptic to the patient.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides compositions having a therapeutically effective amount of zolpidem, carbonate buffer, bicarbonate buffer, and a mixture comprising large and fine particles of silicon dioxide. Compositions having a therapeutically effective amount of zolpidem, carbonate buffer, bicarbonate buffer, and sodium stearyl fumarate are also described.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.

Abstract: The present invention provides novel compositions comprising a combination of a 5-HT3 receptor antagonist and a selective dopamine D2 receptor antagonist for the treatment of obsessive, impulsive and compulsive behavioral activities and other dopamine pathway-associated disorders or conditions. Preferably, the pharmaceutical compositions of the present invention comprise amounts of the 5-HT3 receptor antagonist ondansetron and a selective dopamine D2 receptor antagonist, such as risperidone or olanzapine, that are sufficient to control a subjects obsessive, impulsive and compulsive behavioral activities. Kits comprising the combination of antagonists for the treatment of addictive disorders such as alcohol dependence are also provided.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides novel compositions for the delivery of a 5-hydroxytryptamine (5-HT) agonist across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 9.9, thereby facilitating the substantially complete conversion of the 5-HT agonist from its ionized to its unionized form. As a result, the dose of 5-HT agonist is rapidly and efficiently absorbed by the oral mucosa. Furthermore, delivery of the 5-HT agonist across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating migraines are also provided.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Abstract: The present invention provides novel compositions for the delivery of pilocarpine or a pharmaceutically acceptable salt thereof across the oral mucosa, preferably across the buccal mucosa. In particular, the buffer systems in the compositions of the present invention contain an amount of a strong base that is less than the amount of a weak base, thereby increasing the stability of compositions such as chewing gum compositions and raising the pH of saliva to a pH greater than about 7.5 to facilitate the substantially complete conversion of pilocarpine from its ionized to its un-ionized form. Methods for using the compositions of the present invention for treating conditions such as dry mouth are also provided.

Abstract: The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.

Abstract: Described herein are compositions for delivering a therapeutic agent across the oral mucosa. In general, the compositions comprise at least one therapeutic agent, a carrier, and a buffer system. The therapeutic agents may be acidic, basic, or amphoteric and are initially, at least in part, present in an ionized form. The buffer system comprises at least two different buffering agents and is capable of changing the pH of the saliva from an arbitrary initial pH to a predetermined final pH, independent of the arbitrary initial pH, and of sustaining the final pH for a predetermined period of time. In addition, the buffer systems described herein favor the substantially complete conversion of the ionized form of the therapeutic agent to the un-ionized form so that practically all of the therapeutic agent will be delivered rapidly across the mucous membranes of the oral cavity. Chewing gums, lozenges, and quick-dissolving tablets are exemplified.

Abstract: A therapeutic agent delivery composition containing a functional buffer system for facilitating absorption of pilocarpine in the buccal cavity. More particularly, the composition is used to raise the pH of the buccal cavity so that the pilocarpine agent is delivered in a lipophilic form capable of crossing the buccal membrane. The delivery composition raises the pH of the buccal cavity through the implementation of a buffer system, which comprises a combination of two or more buffer agents. The agents of the buffer system are combined in a manner where the stronger basic agent is at relatively larger levels than that of a corresponding weaker base. The delivery composition may be administered as a chewing gum, where the pilocarpine is effectively absorbed in about 5 minutes after the onset of chewing.