Composition and method for aiding sleep

Abstract

Described is a controlled-release formulation for treating disturbed sleep or insomnia in a subject. The formulation is formulated to release a compound or combination of compounds in sequence at multiple stages.

What is claimed is: 
     
         1 . A controlled-release formulation, comprising one or more compounds for aiding sleep, wherein the formulation is formulated for releasing each compound at a specific time and a specific dose in a subject after the formulation is administered to the subject. 
     
     
         2 . The formulation of  claim 1 , wherein the formulation is formulated for releasing different compounds or different combinations of compounds at different time points in a subject after the formulation is administered to the subject. 
     
     
         3 . The formulation of  claim 1 , wherein the formulation is formulated for releasing the one or more compounds at two or more stages, wherein, at each stage, release of a compound or a combination of compounds is initiated at a specific time in a subject after the formulation is administered to the subject. 
     
     
         4 . The formulation of  claim 3 , wherein the formulation is formulated for two to twelve stages of release. 
     
     
         5 . The formulation of  claim 4 , wherein the time interval between the initiation of each stage of release is 0.5 to 23 hours. 
     
     
         6 . The formulation of  claim 5 , wherein the first stage is for immediate release of one or more compounds. 
     
     
         7 . The formulation of  claim 3 , wherein the one or more compounds are selected from the group consisting of a barbiturate, diazepam, estazolam, flunitrazepam, lorazepam, midazolam, nitrazepam, oxazepam, triazolam, temazepam, chlordiazepoxide, alprazolam, eszopiclone, zaleplon, zolpidem, zopiclone, diphenhydramine, dimenhydrinate, doxylamine, mirtazapine, promethazine, a plant component or extract, Validol, chloral hydrate, trazodone, an opiate, an opioid, Suvorexant, glutethimide, and γ-hydroxybutyric acid. 
     
     
         8 . The formulation of  claim 7 , wherein the formulation contains 0.01 mg to 100 mg of each of the one or more compounds. 
     
     
         9 . The formulation of  claim 8 , wherein the formulation is a tablet or capsule for oral administration. 
     
     
         10 . The formulation of  claim 9 , wherein the tablet is a multi-layered or multi-cored tablet. 
     
     
         11 . The formulation of  claim 9 , wherein the tablet or capsule contains a plurality of particles, each particle including a drug core and a polymeric composition encapsulating the core, wherein the drug core contains one or more compounds for aiding sleep. 
     
     
         12 . The formulation of  claim 3 , wherein the formulation is formulated for a first stage immediate release of an antihistamine, a second stage release of a benzodiazepine that starts 2-3 hours after initiation of the first stage, and a third stage release of a non-benzodiazepine sedative that starts 2-3 hours after initiation of the third stage. 
     
     
         13 . The formulation of  claim 12 , wherein the antihistamine is diphenhydramine HCl, the benzodiazepine is zolpidem tartrate, and the non-benzodiazepine sedative is lorazepam. 
     
     
         14 . The formulation of  claim 13 , wherein the formulation contains 50 mg of diphenhydramine HCl, 5 mg of zolpidem tartrate, and 0.5 mg of lorazepam. 
     
     
         15 . The formulation of  claim 14 , wherein the formulation is a tablet or capsule for oral administration. 
     
     
         16 . The formulation of  claim 15 , wherein the tablet or capsule contains a plurality of particles, each particle including a drug core and a polymeric composition encapsulating the core, wherein the drug core contains zolpidem tartrate or lorazepam. 
     
     
         17 . The formulation of  claim 16 , wherein the polymeric composition includes a polymethacrylate. 
     
     
         18 . The formulation of  claim 13 , wherein the formulation contains diphenhydramine HCl, zolpidem tartrate, and lorazepam as the only three active compounds. 
     
     
         19 . A method of treating disturbed sleep or insomnia in a subject, comprising administering the formulation of  claim 1  to a subject in need thereof. 
     
     
         20 . The method of  claim 19 , wherein the formulation is formulated for a first stage immediate release of an antihistamine, a second stage release of a benzodiazepine that starts 2-3 hours after initiation of the first stage, and a third stage release of a non-benzodiazepine sedative that starts 2-3 hours after initiation of the third stage.