Method for treating or preventing sleep disorders

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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Details

C514S215000, C514S221000, C514S249000

Reexamination Certificate

active

06348485

ABSTRACT:

This application is the National Stage of International Application No. PCT/JP99/03057, filed on Jun. 8, 1999.
1. Technical field
The present invention relates to a pharmaceutical composition for treating or preventing sleep disorders which comprises (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide in combination with at least one active component selected from zolpidem, zopiclone, triazolam and brotizolam.
2. Background art
Sleep disorders can be classified into about 90 different types based on features of the symptoms, cause of the disease, etc. (International Classification of Sleep Disorders (ICSD): In Diagnostic and Coding Manual; American Sleep Disorder Association: Allen Press Inc.: Lawrence, Kans., 1990). Most of the medicines for treating these disorders at present are benzodiazepines and their derivatives. Non-benzodiazepines such as zolpidem, zopiclone, etc., which are comparatively new hypnotics, are structurally different from benzodiazepines, but exhibit the same activities as benzodiazepines through benzodiazepine receptors. It is believed that benzodiazepines lower the activity of information processing by sedating the limbic system and hypothalamus and inducing sleep. Further, it is known that benzodiazepines do not increase REM (rapid eye movement) sleep and increase non-REM sleep only.
On the other hand, it is disclosed in WO 97/32871 that various tricyclic compounds including (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)ethyl]propionamide, have an excellent activity as melatonin agonists and are useful for treating or preventing sleep disorders, etc.


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A. A. Piergies et al., “The effect of co-administration of zolpidem with fluoxetine: pharmacokinetics and pharmacodynamics”, International Journal of Clinical Pharmacology and Therapeutics, vol. 34, No. 4 pp. 178-183(1996).
L. Feerini-Strambi et al., “Effect of Melatonin on Sleep Microstructure: Preliminary Results in Healthy Subjects”, Sleep, vol. 16, No. 8, pp. 744-747 (1993).

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