Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-02-17
2001-04-03
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S217000, C514S384000, C514S252010, C514S253030, C514S255030, C514S659000, C514S453000, C514S923000
Reexamination Certificate
active
06211229
ABSTRACT:
FIELD OF INVENTION
This invention relates to a method for the treatment of individuals suffering from transient or short term insomnia.
BACKGROUND OF THE INVENTION
A large percentage of the adult population suffers from insomnia in some form at some time in their lives. This may vary from a single episode of one night's duration to chronic conditions. Transient insomnia is an insomnia that is present for one to several days, and is less than one week in duration. Short term insomnia is an insomnia of one to three weeks in duration. Chronic insomnia is typically accepted to involve episodes greater than three (3) weeks in duration. The insomnia may further involve onset insomnia (difficulty in falling asleep) and/or maintenance insomnia (difficulty in maintaining uninterrupted sleep). It is well known that the sleep deprivation resulting from such insomnia adversely affects cognition, safety and quality of life.
Known treatments for insomnia include the administration of medication, either of the non-barbiturate or barbiturate type, shortly before bedtime. While both types of sedatives may be used to effectively treat insomnia, neither is without its undesirable side effects. Barbiturate type sedatives, such as secobarbital (sold by Eli Lilly and Company under the tradename of Seconal®) are general depressants. While effective, these medications are well known to lose their effectiveness after a few days. Furthermore, they are highly addictive and commonly abused. They are therefore no longer widely prescribed.
The groups of medications now most commonly used for the treatment of insomnia are the imidazopyridines, the pyrazolopyrimidines and the benzodiazepines. There is one available hypnotic in the imidazopyridine group, one in the pyrazolopyrimidine group and there are five in the benzodiazepine group. They differ significantly in half lives but are otherwise very similar and equally effective. They have supplanted the barbiturates as the principal treatment for insomnia because they have less addiction potential and are associated with less risk for suicide than the barbiturates unless taken with alcohol. However, these groups, too, are addictive and their wide usage draws concern as their potential side effects become more apparent. These side effects include daytime sedation, decreased cognitive abilities such as memory loss and feelings of agitation after the drug's therapeutic effects pass.
In my prior inventions which issued as U.S. Pat. Nos. 5,502,047 and 5,643,897, I disclosed the novel use of low dose doxepin, amitriptyline, trimipramine, trazodone and mixtures thereof in the treatment of chronic insomnia. These medications are normally prescribed in high dosages for use as antidepressants (150-300 mg). All these medications have long half-lives, take several days to reach a steady state and take a minimum of 3-4 weeks to effect change in depressive affect. As such, those of ordinary skill in the art would expect that it would take a minimum of several days and as long as a month for such medications to effect a correction of an insomnia and thus their usefulness in chronic insomnia. A thorough study of my data, however, reveals the surprising fact that many patients benefited from the medications from day one of administration. That means that these medications, that have literally no effect on depression in the first days of administration, can, even at very low doses, have an immediate effect on insomnia, even before reaching steady state. This suggests an immediate mechanism of action that is entirely different from its action after weeks of accumulation, seemingly a direct neurochemical effect on sleep-wake mechanisms, an effect that is not at all obvious and, in fact, entirely unexpected considering the pharmacokinetics of the medications and their usefulness, to date, only in chronic conditions. With that recognition I have gone on to treat subjects with transient and short term insomnia and have discovered that very low doses of the stated medications (doxepin, amitriptyline, trimipramine, trazadone and mixtures thereof) can have an immediate beneficial effect on the sleep of subjects with transient and short term insomnia and are, therefore, useful agents for the treatment of individuals suffering from transient and short term insomnia of any etiology including the circadian desynchronization of jet lag.
OBJECTS OF THE INVENTION
It is an object of the present invention to develop a method for the successful treatment of transient and short term insomnia.
It is also an object of the present invention to develop a method for the successful treatment of insomnia other than chronic insomnia.
It is further an object of the present invention to develop a method for the successful treatment of insomnia associated with jet lag.
It is still another object of the present invention that the above methods involve the administration of non-addictive medications.
It is still a further object of the present invention to develop a method which does not involve the adverse effects associated with the current prescription hypnotics, i.e. residual sedation, lethargy, drowsiness, loss of cognitive ability and/or agitation.
SUMMARY OF THE INVENTION
The present invention is directed to a method for the treatment of a patient suffering from transient or short term (non-chronic) insomnia. The claimed method comprises administering to said patient a compound selected from the group consisting of the pharmaceutically acceptable forms of doxepin, amitriptyline, trimipramine, trazodone and mixtures thereof. The dosage for administration of doxepin, amitriptyline, trazodone, trimipramine and mixtures thereof ranges from about 0.5 to about 20.0 milligrams.
In one preferred embodiment of the present invention, the invention involves the administration to said patient doxepin, amitriptyline, trimipramine or mixtures thereof in a dosage of about 10 milligrams or less.
In another preferred embodiment of the present invention, the invention involves the administration to said patient trazodone in a dosage of about 15 milligrams or less.
DESCRIPTION OF THE INVENTION
The present invention is directed to a method for the treatment of a patient suffering from transient or short term (non-chronic) insomnia through the administration of very small doses of specific known psychotherapeutic agents. The claimed method may be used for the treatment of onset and/or maintenance insomnia.
The agents useful in the claimed invention include tricyclic compounds and a triazolopyridine derivative which are currently prescribed for the general treatment of depression. They are also prescribed for the treatment of the insomnia component of a depression in individuals suffering from depression. These compounds are known to possess a sedative effect in such individuals when administered in their normally-prescribed and available dosages (described below). The medications are now also being used in available dosages for the treatment of some subjects with insomnia. However, the use of these compounds at the extremely low dosages claimed herein for the successful treatment of transient or short term (non-chronic) insomnia in otherwise healthy individuals has not been reported and is not obvious in view thereof. For example, the compounds used in the present invention are currently prescribed for a 20-60 year old depressed patient population in dosages varying from about 75 to about 300 milligrams per day of the tricyclic compounds and about 150 to about 600 milligrams per day of the triazolopyridine compound. Further, the entire dosage of such medications is often administered at bedtime. In contrast to the above, the method of the present invention involves the use of a small fraction of such dosages.
The method of the present invention involves the administration of doxepin, amitriptyline, trimipramine, trazodone and mixtures thereof. As noted above, these compounds are well known psychotherapeutic agents which are currently prescribed as antidepressants. Each compound is further readily available comm
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