Methods of treating middle-of-the-night insomnia
DC CAFC
First Claim
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1. A method of treating middle-of-the-night insomnia in a non-elderly patient without prophylactically administering zolpidem, comprising:
- dosing the patient with a pharmaceutical composition comprising about 0.5 to about 4.75 mg of zolpidem hemitartrate or a molar equivalent amount of a pharmaceutically acceptable form of zolpidem, wherein the pharmaceutical composition is substantially free of other hypnotic agents, wherein the patient awakens from sleep, and desires to resume sleep for less than 5 hours,wherein the step of dosing the pharmaceutical composition is performed after the patient awakens from sleep, andwherein the pharmaceutical composition permits the patient to awaken at a time about four hours after dosing without residual sedative effects.
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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.
129 Citations
25 Claims
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1. A method of treating middle-of-the-night insomnia in a non-elderly patient without prophylactically administering zolpidem, comprising:
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dosing the patient with a pharmaceutical composition comprising about 0.5 to about 4.75 mg of zolpidem hemitartrate or a molar equivalent amount of a pharmaceutically acceptable form of zolpidem, wherein the pharmaceutical composition is substantially free of other hypnotic agents, wherein the patient awakens from sleep, and desires to resume sleep for less than 5 hours, wherein the step of dosing the pharmaceutical composition is performed after the patient awakens from sleep, and wherein the pharmaceutical composition permits the patient to awaken at a time about four hours after dosing without residual sedative effects. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 21, 22, 23)
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12. A method of treating middle-of-the-night insomnia in an elderly patient without prophylactically administering zolpidem, comprising:
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dosing the patient with a pharmaceutical composition comprising about 1.5 to about 2.5 mg of zolpidem hemitartrate or a molar equivalent amount of a pharmaceutically acceptable form of zolpidem, wherein the pharmaceutical composition is substantially free of other hypnotic agents, wherein the patient awakens from sleep, and desires to resume sleep for less than 5 hours, wherein the step of dosing the pharmaceutical composition is performed after the patient awakens from sleep, and wherein the pharmaceutical composition permits the patient to awaken at a time about four hours after dosing without residual sedative effects. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 24, 25)
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Litigation Data
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Current AssigneeParatek Pharmaceuticals Incorporated
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Original AssigneeTranscept Pharmaceuticals Incorporated
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InventorsSingh, Nikhilesh, Pather, Sathasivan Indiran
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Primary Examiner(s)CLAYTOR, DEIRDRE RENEE
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Application NumberUS11/439,874Publication NumberTime in Patent Office2,275 DaysField of Search514/294, 514/923US Class Current514/294CPC Class CodesA61K 31/4745 condensed with ring systems...A61K 9/0056 Mouth soluble or dispersibl...A61K 9/006 Oral mucosa, e.g. mucoadhes...A61K 9/2009 Inorganic compoundsA61K 9/2018 Sugars, or sugar alcohols, ...A61K 9/2027 obtained by reactions only ...A61P 25/20 Hypnotics; Sedatives
