Sepracor, Inc.

Sunovion Pharmaceuticals Inc.

The Mclean Hospital Corporation

Timothy J Barberich

Paul D Rubin

James W Young

William E Yelle

Martin H Teicher

William J Wechter

Stephen L Matson

Thomas Wessel

Judy Caron

Karim Lalji

The present invention generally relates to pharmaceutical compositions comprising a dopamine agonist and sedative agent. In a preferred embodiment, the dopamine agonist is optically pure (S)-didesmethylsibutramine. In a preferred embodiment, the sedative agent is optically pure (S)-zopiclone or optically pure (S)&#x2014;N-desmethylzopiclone. In a preferred embodiment, the dopamine agonist is optically pure (S)-didesmethylsibutramine; and the sedative agent is optically pure (S)-zopiclone or optically pure (S)&#x2014;N-desmethylzopiclone. The pharmaceutical compositions of the invention are useful in the treatment of restless-leg syndrome and periodic-limb-movement disorder, as well as various sleep disorders. In addition, the present invention relates to a method of treating a patient suffering from restless-leg syndrome, periodic-limb-movement disorder, a sleep abnormality, or insomnia, comprising coadministering a therapeutically effective amount of a dopamine agonist and a therapeutically effective amount of a sedative agent. In a preferred embodiment, the dopamine agonist is optically pure (S)-didesmethylsibutramine. In a preferred embodiment, the sedative agent is optically pure (S)-zopiclone or optically pure (S)&#x2014;N-desmethylzopiclone. In a preferred embodiment, the dopamine agonist is optically pure (S)-didesmethylsibutramine; and the sedative agent is optically pure (S)-zopiclone or optically pure (S)&#x2014;N-desmethylzopiclone.

Dopamine-agonist combination therapy for improving sleep quality

One aspect of the present invention relates to pharmaceutical compositions containing two or more active agents that when taken together can be used to treat, e.g., insomnia and/or depression. The first component of the pharmaceutical composition is a GABA receptor modulating compound. The second component of the pharmaceutical composition is a serotonin reuptake inhibitor, a norepinephrine reuptake inhibitor, a 5-HTmodulator, or dopamine reuptake inhibitor. In certain embodiments, the pharmaceutical composition comprises eszopiclone. In a preferred embodiment, the pharmaceutical composition comprises eszopiclone and fluoxetine. The present invention also relates to a method of treating a sleep abnormality, treating insomnia, treating depression, augmenting antidepressant therapy, eliciting a dose-sparing effect, reducing depression relapse, improving the efficacy of antidepressant therapy or improving the tolerability of antidepressant therapy, comprising co-administering to a patient in need thereof a GABA-receptor-modulating compound; and a SRI, NRI, 5-HTmodulator or DRI.

Combination of sedative and a neurotransmitter modulator, and methods for improving sleep quality and treating depression

Methods for prophylaxis of or treating or preventing migraine or migraine headaches, or other headache disorders include administering to a subject in need of treatment a therapeutically effective amount of citalopram, escitalopram, or a racemic or optically pure citalopram metabolite, or pharmaceutically acceptable salts, solvates, polymorphs, or hydrates thereof.

Treatment or prophylaxis of migraine or headache disorders using citalopram, escitalopram or citalopram metabolites

Methods for the prophylaxis, treatment, or management of irritable bowel syndrome using (&#x2212;) norcisapride, or a pharmaceutically acceptable salt thereof, substantially free of its (+) stereoisomer are disclosed.

Methods for treating irritable bowel syndrome using optically pure (-) norcisapride

The invention relates to novel methods using, and pharmaceutical compositions comprising, ziprasidone metabolites. The methods and compositions of the invention are suitable for the treatment of neuroleptic and related disorders. The invention further encompasses methods of preparing ziprasidone sulfoxide and ziprasidone sulfone.

Methods for the treatment of neuroleptic and related disorders using ziprasidone metabolites

Methods for the prevention, treatment, or management of apnea, apnea disorders, bulimia, nervosa, irritable bowel syndrome, urinary incontinence, bradycardia, bradyarrhythmia, syncope, other disorders, or symptoms thereof using (&plus;) norcisapride, or a pharmaceutically acceptable salt thereof, substantially free of its (&minus;) stereoisomer.

Methods for treating sleep apnea and sleep induced apnea using optically pure (&plus;) norcisapride

Methods for the treatment, management, or prevention of apnea and apnea disorders, or symptoms thereof, using a therapeutically effective amount of substantially optically pure R(&plus;) ondansetron, or a pharmaceutically acceptable salt thereof, substantially free of its S(&minus;) stereoisomer.

Methods for treating apnea and apnea disorders using optically pure R(&plus;) ondansetron

Methods for the prevention, treatment, or management of apnea, apnea disorders, bulimia nervosa, irritable bowel syndrome, urinary incontinence, bradycardia, bradyarrhythmia, syncope, other disorders, or symptoms thereof using (&minus;) norcisapride, or a pharmaceutically acceptable salt thereof, substantially free of its (&plus;) stereoisomer.

Methods for treating bulimia using optically pure (&minus;) norcisapride

The invention relates to methods and compositions for the prevention, treatment, or management of gastrointestinal disorders or symptoms thereof, employing two or more agents or compounds to provide a triple site action on 5-HT receptors, 5-HT receptors, and at least one of H receptors and proton pumps.

Methods and compositions using (&plus;) norcisapride in combination with proton pump inhibitors or H2 receptor antagonists

The invention relates to methods and compositions for the prevention, treatment, or management of gastrointestinal disorders or symptoms thereof, employing two or more agents or compounds to provide a triple site action on 5-HT receptors, 5-HT receptors, and at least one of H receptors and protons pumps.

Methods of treating gastro-esophogeal reflux disease using (-) norcisapride in combination with proton pump inhibitors or H2 receptor antagonists

The R-isomer of the hydroxy metabolite of nefazodone, R-hydroxynefazodone, is an effective treatment for depression which does not give rise to the adverse effects associated with nefazodone. R-hydroxynefazodone is also useful in the treatment of migraine headaches, panic disorders, post traumatic stress disorder and sleep disorders.

R-hydroxynefazodone

The S-isomer of the hydroxy metabolite of nefazodone, S-hydroxynefazodone, is an effective treatment for depression which does not give rise to the adverse effects associated with nefazodone. S-hydroxynefazodone is also useful in the treatment of migraine headaches, panic disorders, post traumatic stress disorder and sleep disorders.

S-hydroxynefazodone

Methods for the prevention, treatment, or management of apnea, apnea disorders, bulimia nervosa, irritable bowel syndrome, urinary incontinence, bradycardia, bradyarrhythnia, syncope, other disorders, or symptoms thereof using (&plus;) norcisapride, or a pharmaceutically acceptable salt thereof, substantially free of its (&minus;) stereoisomer.

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Concord, MA, United States of America

Timothy J Barberich