To provide a pharmaceutical composition for treating middle-of-the-night (MOTN) insomnia, and a method for using the composition.
The invention provides a solid pharmaceutical composition including zolpidem, serving as sedative-hypnotics, or a salt thereof; and a method for using the pharmaceutical composition in a treatment of a subject who awakens from sleep, has difficulty in returning to sleep, and desires to resume sleep for less than 5 hours after awakening. The composition is suitable for administering a pharmaceutical composition comprising an effective amount of less than 1.30×10-5 moles of zolpidem to induce effective sleep or a salt thereof. A step of dosing the composition is carried out after the subject awakens from sleep. The composition provides delivery of zolpidem via a subject's oral mucosa and dissolves or disintegrates in about 10 minutes or less in the subject's mouth. The usage preferably includes a dose permitting the subject to awaken at a time 4 hours after dosing without residual sedative effects. The composition is a lozenge or a tablet and preferably administered sublingually.
PATHER SATHASIVAN INDIRAN
| JP2002526439A | 2002-08-20 | |||
| JP2008517988A | 2008-05-29 | |||
| JP2007523091A | 2007-08-16 |
| WO2005032519A1 | 2005-04-14 | |||
| WO2004091585A1 | 2004-10-28 |
Samejima Mutsumi
Masahiro Nitta
Kure Hidenori
Nobuhiko Akiyama
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