Title:  Use of valeriana for the treatment of restless leg syndrome and related disorders

United States Patent:  6,346,283

Assignee:  Ancile Pharmaceuticals ()

Filed:  December 30, 1999

A novel method of inhibiting at least one symptomology of Restless Legs Syndrome (RLS) and its related disorders, including disorders such as periodic limb movements in sleep (PLMS) and periodic limb movement disorder (PLMD), is disclosed. Said method optionally comprising identifying a host, preferably a human, afflicted with Restless Legs Syndrome (RLS) and its related disorders; and comprising administering to said host a pharmaceutically effective amount of Valeriana, preferably an extract of Valeriana. A novel method of inhibiting at least one symptomology of Restless Legs Syndrome (RLS) and its related disorders is disclosed. The method may also be used to treat a host in order to diminish undesired limb movements, and may involve the administration of a particular compound, found in the above-mentioned extracts, preferably selected from the group consisting of 10(14)-Aromadendren-4-ol, 6,10(14)-Guaiadien-4-ol, Valerenal, Valerenol, Valerenic acid, Acetoxyvalerenic acid, Hydroxyvalerenic acid, mimetics thereof, and may involve the administration of a combinations of these particular compounds and mimetics thereof.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In a preferred embodiment, the present invention provides a natural plant extract, and particularly an extract of Valeriana, and more particularly an extract from Valeriana officinalis L., that affects the peripheral and central nervous system in a manner that alleviates the symptomologies of Restless Legs Syndrome (RLS) and related disorders. Further, the present invention provides the advantage of alleviating the symptomologies of RLS and related disorders without causing the side effects associated with benzodiazipine-type treatment, and other current treatment or treatments of, RLS and related disorders. The present invention provides the advantage of providing an alternative treatment option for RLS and related disorders, of which there is a need in the art.

Another advantage of the present invention, which includes the use of Valerian extract in the treatment of RLS and related disorders, is that extracts of Valeriana have not been shown to cause such side effects and therefore, the treatment of RLS with Valeriana may increase compliance for the RLS patient as well as address the specific problem of insomnia associated with RLS and/or other pharmaceutical treatments for RLS. These current treatments have a wide variety of negative side effects, which have been reported and detailed (Silber, 1997). Also, tolerance to the treatment can develop, causing the efficacy of a particular treatment regime to diminish with time. Also, rebound phenomena are associated with currently known treatments (Krueger, 1990; Hornyak et al., 1998). Additionally, and as would be appreciated by one skilled in the art, current treatments such as benzodiazipines are associated with a host of unwanted effects such as memory loss, addiction potential, and other related side effects.

As used herein, the terms "Valeriana" and "valerian" each refer to any plant of the Valerianaceae, and therefore refers, at least to, the plant designated Valeriana officinalis L. This species includes all recognized subspecies of Valeriana officinalis L. Some of these subspecies are also commonly referred to, in alternative taxonomic systems, as: Valeriana exaltata J. C. Mikan, Valeriana nitida Kreyer, Valeriana palustris Wibel, Valeriana wolgenis Kazak, Valeriana grossheimii Vorosch, Valeriana collina Wallr, Valeriana Rossica P. A. Smirn, Valeriana spryngini P. S. Smirn, Valeriana angustifolia Tausch, Valeriana tenuifolia Vahl, Valeriana wallrothii Kreyer, Valeriana ucrainica Demjan, Valeriana sambucifolia J. C. Mikan, Valeriana excelsa Poir, and Valeriana officinalis L. sp. excelsa (Poir.) Rouy. Plants of the species Valeriana officinalis L. may be characterized as follows: These plants grow from a short rhizome to 2 m high, flowers, and then die back again in the winter. These plants have pinnately-divided leaves with six to ten pairs of lance-shaped leaflets, and bear many small white or pink flowers in a dense head of several stalked clusters. The heads bare small (5 mm) tapered seeds.

As used herein, the term "root" or "roots" refers to all of subterranean portion of a specifically or generically identified plant, including, but not limited to, the roots, the rhizomes, and the stolons of the specifically or generically identified plant. Where the term "roots" is not modified by a specifically or generically identified plant, it will be understood that the term refers to the roots of the genus, and the various species, of Valeriana.

As used herein the term "Restless Legs Syndrome (RLS) and related disorders" means diseases, disorders, syndromes or conditions characterized by periodic limb movements such as periodic limb movements such as in sleep (PLMS) and periodic limb movement disorder (PLMD), and the treatment of such diseases, disorders, syndromes or conditions includes any pharmacological means of diminishing the occurrence of unwanted limb movements.

As used herein, the terms "reduces," "reduced," or "reducing," when used to refer to one or more symptomology of a disease, refers to any observable lessening of that characteristic when the method or composition of the present invention is compared to prior art methods or compositions.

As used herein, the terms "disorder" and "disease" refer to any disorder, disease, condition, syndrome or combination of manifestations or symptoms recognized or diagnosed as a disorder. If modified by reference to a particular disease or by reference one or more or a set of manifestations or symptoms, that usage of "disorder" or "disease" refers to any such disorder, disease, condition, syndrome or combination of such manifestations or symptoms recognized or diagnosed as a such disorder.

As used herein, the term "pharmaceutically effective amount" refers to an amount sufficient to alleviate, in any degree or manner, one or more of the manifestations or symptoms recognized or diagnosed as associated with the modifying disorder, the modifying manifestations, or the modifying symptom.

Claim 1 of 19 Claims

What is claimed is:

1. A method for diminishing undesired limb movements in a host, the method comprising the step of:

administering to the host a pharmaceutically effective amount of one or more compounds of Valeriana selected from the group consisting of 10(14)-Aromadendren-4-ol, 6,10(14)-Guaiadien-4-ol, Valerenal, Valerenol, Valerenic acid, Acetoxyvalerenic acid, Hydroxyvalerenic acid and combinations thereof.

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