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Solid compositions for treating middle-of-the-night insomnia and method therefor

A composition, subject's technology, applied in the field of TN insomnia, capable of solving the problems of excess, administration about 7 to 9 hours before bed, slow sleep, etc.

Inactive Publication Date: 2012-06-20
TRANSPORT PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, currently available hypnotics are not suitable for the treatment of MOTN insomnia because they induce sleep very slowly (eg zaleplon) and / or need to be administered approximately 7 to 9 hours before bedtime to avoid residual sleep in the morning Drowsiness (eg, zolpidem, eszopiclone, and zopiclone formulations are available)
Also, most currently available hypnotics are administered prophylactically, leading to unnecessary and over-medicated medication in people who need to treat their MOTN insomnia several nights a week

Method used

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  • Solid compositions for treating middle-of-the-night insomnia and method therefor
  • Solid compositions for treating middle-of-the-night insomnia and method therefor
  • Solid compositions for treating middle-of-the-night insomnia and method therefor

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0139] Those skilled in the art will recognize that the preparation of a gum base need not begin with its individual components. For example, gum bases can be purchased that contain the desired ingredients therein, and can be modified to include additional agents. There are several manufacturers of gum bases suitable for use in such chewing gum compositions. Examples of such gum bases include, but are not limited to, Pharmagum TM M, S, or C (SPIPharma Grollp; New Castle, DE). Usually, Pharmagum TM Contains gum base, sweeteners, plasticizers, and sugar mixtures.

[0140]In some instances, the chewing gum composition includes a therapeutic agent centerfill. Center-fills are particularly suitable when immediate release of the therapeutic agent is preferred. Additionally, encapsulating the therapeutic agent within the center-fill can help mask any undesired taste the therapeutic agent may have. In these cases, the gum base at least partially surrounds the center-fill. The ...

Embodiment 1

[0188] Example 1. Low Dose Zolpidem Lozenge Composition

[0189] Sublingual delivery lozenges containing 0 mg, 1.0 mg, 1.75 mg or 3.5 mg zolpidem prepared according to the formulation listed in Table 3 were administered to subjects suffering from midnight insomnia.

[0190] Table 3. Low-Dose Zolpidem Lozenge Formulations

[0191]

[0192]

[0193] These individuals self-administered one of the above formulations when their sleep was interrupted and they had at least 2 hours of sleep time remaining. Upon awakening, the individuals provided a subjective self-assessment of any residual sedation and were given the following psychomotor and memory tests to assess any residual sedation: Digit Symbol Substitution Test (DSST), Choice Reaction Time Test (CRT) , Symbol Reproduction Test (SCT) and Buschke memory recall test.

[0194] Individuals who received the placebo were generally unable to fall back to sleep and therefore did not feel refreshed in the morning. Individuals r...

Embodiment 2

[0195] Example 2. Study on pharmacokinetics and pharmacodynamics of low-dose zolpidem lozenge composition

[0196] This example provides an evaluation of the daytime dose-dependent pharmacokinetic and pharmacodynamic effects of the 1.0 mg, 1.75 mg and 3.5 mg zolpidem lozenges described in Table 3 above.

[0197] overview

[0198] Currently, no drug is available, when needed, for patients with middle of the night (MOTN) awakenings and difficulty falling back to sleep. Therapeutic agents suitable for such insomnia enable the patient to return to sleep quickly and have no residual effect upon waking in the morning. In particular, this study demonstrates that the low-dose zolpidem lozenge of the present invention enhances the rapid systemic absorption of zolpidem without affecting other pharmacokinetic parameters.

[0199] This study is a double-blind, placebo-controlled four-group cross-over study. Two consecutive mornings, healthy adults (n=24; average age=37.6 years old) who ...

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PUM

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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.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Application 60 / 684,842, filed May 25, 2005, U.S. Provisional Application 60 / 741,673, filed December 1, 2005, U.S. Provisional Application 60 / 788,340, filed March 31, 2006, Priority to US Provisional Application 60 / 788,249 filed March 31, 2011, the disclosure of which is hereby incorporated by reference in its entirety for all purposes. Background of the invention [0003] Until recently, four types of insomnia were recognized in the medical literature, including sleep onset insomnia (eg, difficulty falling asleep at bedtime), sleep maintenance insomnia (eg, disturbance of sleeping during the night), early morning awakening (early morning awakening) and transient insomnia (eg new environment, hotel first night syndrome). However, according to the National Sleep Foundation's 2005 "Sleep in America" ​​questionnaire, about 20 percent of total respondents and about 50 percent of respo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/415A61K9/20
Inventor N·辛格S·I·帕特尔
Owner TRANSPORT PHARMA INC
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