| 摘要 |
There is provided a formulation suitable for transmucosal administration comprising a short acting hypnotic drug, which formulation provides a measurable plasma concentration of drug within 10 minutes of administration. The formulation is capable of providing sleep on demand, and preferably comprises particles of drug, for example zolpidem or a pharmaceutically-acceptable salt thereof and a mucoadhesion promoting agent, such as sodium carboxymethylcellulose, which particles of drug and mucoadhesive are presented upon the surface of larger carrier particles. |
| 主权项 |
1. A method of treating insomnia in an individual by sublingual administration of a pharmaceutical composition, the method comprising:
providing the pharmaceutical composition in a dosage form comprising a tablet sized for placement under a tongue, wherein the pharmaceutical composition comprises
(a) carrier particles having exterior surfaces,(b) particles of zolpidem or a pharmaceutically acceptable salt thereof sized smaller than the carrier particles and presented, at least in part, upon the exterior surfaces of the carrier particles and the dose of zolpidem or salt thereof per tablet is in the range of about 5 mg to about 12 mg; and(c) particles of a mucoadhesion promoting agent sized smaller than the carrier particles and presented, at least in part, upon the exterior surfaces of the carrier particles, wherein both the particles of zolpidem or a pharmaceutically acceptable salt thereof and the particles of the mucoadhesion promoting agent are presented, at least in part, upon the exterior surfaces of the carrier particles; and sublingually administering the pharmaceutical composition to the individual to treat the insomnia by placing the tablet under the tongue of the individual, wherein sublingual administration of the pharmaceutical composition provides a therapeutic outcome comprising
(i) a measurable plasma concentration of zolpidem within 10 minutes of sublingual administration; and(ii) a time difference following sublingual administration between a first measurable plasma concentration of zolpidem and a maximum measured plasma concentration of zolpidem that is within a range of about 80 minutes to about 160 minutes; and(iii) a plasma concentration of zolpidem that is capable of maintaining sleep for at least about 6 hours after sublingual administration. |
