Methods for treating patients suffering from drug dependencies which leads to plasma melatonin deficiencies

Abstract

A method of treating a patient suffering from a dependence on, tolerance of, or addiction to at least one benzodiazepine comprises administering melatonin to said patient on a daily basis in an amount sufficient to treat said dependence on, tolerance of, or addiction to said benzodiazepine.

1 . A method of treating a patient suffering from a dependence on, tolerance of, or addiction to at least one benzodiazepine, which comprises administering melatonin to said patient on a daily basis in an amount sufficient to treat said dependence on, tolerance of, or addiction to said benzodiazepine, wherein said melatonin is administered in a controlled release formulation which provides for the release of melatonin so as to produce a plasma melatonin profile in the patient which substantially simulates the plasma melatonin profile of a human having a normal endogenous melatonin plasma profile.  
     
     
         2 . A method in accordance with  claim 1 , wherein the melatonin is administered in an amount such that the patient achieves a minimal blood level of about 60 to about 200 picograms melatonin per milliliter for a period of at least four hours following the melatonin administration.  
     
     
         3 . A method in accordance with  claim 1 , wherein the melatonin is administered in combination with a melatonin receptor modifier or a melatonin profile modifier.  
     
     
         4 . A method in accordance with  claim 3 , wherein the melatonin receptor modifier comprises a short-acting benzodiazepine.  
     
     
         5 . A method in accordance with  claim 3 , wherein the melatonin profile modifier comprises a benzodiazepine, a beta blocker, an alpha antagonist or a serotonin uptake inhibitor.  
     
     
         6 . A method in accordance with  claim 1 , wherein the melatonin is administered in conjunction with light therapy.  
     
     
         7 . A method in accordance with  claim 1 , wherein the melatonin is administered at a daily dosage level of about 0.01 to about 100 mg.  
     
     
         8 . A method in accordance with  claim 7 , wherein the melatonin is administered at a daily dosage level of about 0.5 to about 5 mg.  
     
     
         9 . A method in accordance with  claim 2 , wherein the melatonin is in particulate form comprising particles coated with a physiologically acceptable coating material which dissolves following administration to a human and the desired release profile is achieved by at least one of: 
 (a) varying the particle size of the melatonin;    (b) dividing the melatonin particles into at least two portions and coating the particle in each portion with a different coating material, wherein said coating materials dissolve at different rates in the human body; or    (c) varying the thickness of the coating materials on the melatonin particles such that particles with different thicknesses of coating material dissolve at different rates following administration to the human body.