Title:  Methods and compositions for treating or preventing sleep disturbances and associated illnesses using very low doses of cyclobenzaprine

United States Patent:  6,395,788

Assignee:  Vela Pharmaceuticals, Inc. (Lawrenceville, NJ)

Filed:  August 11, 2000

The present invention relates to methods and compositions comprising a very low dose of cyclobenzaprine or metabolite thereof for preventing and treating sleep disturbances and illnesses manifested with sleep dysfunction including fibromyalgia syndrome, chronic fatigue syndrome, sleep disorders, psychogenic pain disorders or chronic pain syndromes or symptoms thereof. The present invention further relates to methods and compositions for treating sleep disturbances, chronic pain or fatigue in humans suffering from fibromyalgia syndrome, chronic fatigue syndrome, sleep disorders, psychogenic pain disorders, chronic pain syndromes using a very low dose of cyclobenzaprine.

SUMMARY OF THE INVENTION

An object of this invention is to provide methods and compositions for treating a human suffering from sleep disturbances. Accordingly, the present invention relates to methods and compositions for treating or preventing sleep disturbances in humans using very low doses of cyclobenzaprine or metabolites thereof.

The methods and compositions of the invention are useful in treating sleep disturbances in general. Such sleep disturbances may be caused by stress or anxiety, disease, pain, the administration of a drug such as benzodiazepines, barbiturates, or alcohol. They are particularly useful in treating sleep disturbances caused by, exacerbated by or associated with fibromyalgia syndrome, prolonged fatigue, chronic fatigue, chronic fatigue syndrome, a sleep disorder, a psychogenic pain disorder, chronic pain syndrome (type II), the administration of a drug, autoimmune disease, stress or anxiety.

In another embodiment, this invention provides methods and compositions for treating a human suffering from an illness caused by or exacerbated by sleep disturbances, and symptoms of such illness. Such illnesses include fibromyalgia, prolonged fatigue, chronic fatigue and chronic fatigue syndrome, sleep disorder, psychogenic pain disorder, and chronic pain syndrome. In the context of this embodiment of the invention, applicant has found that administration of less than 5 mg/day qHS of cyclobenzaprine is not only surprisingly effective at treating the sleep disturbance of many patients who suffer from fibromyalgia, and those other diseases, but the patients also experienced relief from fatigue and diffuse pain. Without wishing to be bound by theory, applicant believes cyclobenzaprine given at very low dose unexpectedly alleviates sleep disturbances and deepens sleep, which may be important for treating fibromyalgia and other illnesses associated with sleep disturbances.

Another object of this invention is to provide methods and compositions for treating sleep disturbances in a human who usually deepens sleep through exercise during waking hours but who cannot because of injury.

Another object of this invention is to provide improved methods and compositions for treating somatised symptoms, including pain, in patients suffering from irritable bowel syndrome and tension headaches, associated with fibromyalgia, chronic fatigue syndrome, psychogenic pain disorders, or chronic pain syndromes.

In still a further embodiment of this invention, the methods of this invention comprise the administration of very low doses of cyclobenzaprine or a metabolite thereof with one or more therapeutic agents such as a tricyclic antidepressant (TCA), a selective serotonin-reuptake inhibitor (SSRI); an atypical antidepressant; an anti-inflammatory agent; or an analgesic. In addition to working with these drugs to alleviate symptoms of underlying physiological problems, cyclobenzaprine also treats sleep disturbances caused by the administration of these drugs.

In another embodiment, the methods of this invention further comprise the administration of very low doses of cyclobenzaprine or a metabolite thereof in combination with psychotherapy or light-box therapy.

Another object of this invention is to provide a composition comprising a very low dose of cyclobenzaprine or a metabolite thereof as a single unit or composition that is pre-prepared into separable portions that comprise a very low dose of cyclobenzaprine or metabolite thereof, which composition is better for treating patients and aiding practitioners to determine appropriate dosage regimens for patients. Such compositions, as well as the other compositions of this invention, may additionally comprise one or more therapeutic agents such as a TCA, a SSRI, an atypical antidepressant, an anti-inflammatory or an analgesic.

These and the other objects of this invention are accomplished by methods and compositions characterized by very low dosage regimens of cyclobenzaprine. Such methods and compositions unexpectedly treat or prevent sleep disturbances.

Claim 1 of 29 Claims

I claim:

1. A method for treating a sleep disturbance comprising the step of administering to a human in need of treatment for such sleep disturbance a composition comprising cyclobenzaprine or a metabolite, prodrug, or salt thereof in an amount of less than 5 mg/day, wherein the human is not suffering from the fibromyalgia syndrome.

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