Treatment of circadian rhythm disorders

Abstract

Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.

What is claimed is: 
     
         1 . A method of treating a patient for a circadian rhythm disorder or for a sleep disorder wherein the patient is being treated with a strong CYP1A2 inhibitor, the method comprising:
 (A) discontinuing the CYP1A2 inhibitor treatment and then   (B) treating the patient with tasimelteon,   thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor.   
     
     
         2 . The method of  claim 1 , wherein the patient is light perception impaired (LPI). 
     
     
         3 . The method of  claim 1 , wherein the patient is totally blind. 
     
     
         4 . The method of  claim 1 , wherein the patient suffers from Non-24-Hour Sleep-Wake Disorder. 
     
     
         5 . A method of treating Non-24-Hour Sleep-Wake Disorder in a patient suffering therefrom, said method comprising internally administering to the patient an effective amount of tasimelteon. 
     
     
         6 . A method of treating a patient for a circadian rhythm disorder or for a sleep disorder, the method comprising:
 (i) if the patient is being treated with a CYP3A4 inducer, then
 (A) maintaining the CYP3A4 inducer treatment and treating the patient for the circadian rhythm disorder or for the sleep disorder other than with tasimelteon or 
 (B) discontinuing the CYP3A4 inducer treatment and then treating the patient with tasimelteon, 
   thereby avoiding the use of tasimelteon in combination with a CYP3A4 inducer, and   (ii) if the patient is not being treated with a CYP3A4 inducer, then treating the patient with tasimelteon, thereby avoiding the use of tasimelteon in combination with a CYP3A4 inducer.   
     
     
         7 . The method of  claim 6  comprising:
 if the patient is not being treated with a strong CYP1A2 inhibitor or a CYP3A4 inducer, then treating the patient with tasimelteon or 
 if the patient is being treated with a strong CYP1A2 inhibitor or a CYP3A4 inducer, then 
 (A) maintaining the treatment with the CYP1A2 inhibitor and treating the patient for the circadian rhythm disorder or the sleep disorder other than with tasimelteon or 
 (B) maintaining the treatment with the CYP3A4 inducer and treating the patient for the circadian rhythm disorder or the sleep disorder other than with tasimelteon or 
 (C) if the patient is being treated with both, then maintaining the treatment with the CYP1A2 inhibitor and with the CYP3A4 inducer and treating the patient for the circadian rhythm disorder or the sleep disorder other than with tasimelteon or 
 (D) discontinuing the treatment with the CYP1A2 inhibitor or the CYP3A4 inducer (or, if the patient is being treated with both, then discontinuing treatment with both) and then treating the patient with tasimelteon, 
 
       thereby avoiding the use of tasimelteon in combination with a strong CYP1A2 inhibitor and with a CYP3A4 inducer. 
     
     
         8 . The method of  claim 7  wherein the CYP1A2 inhibitor is fluvoxamine, ciprofloxacin, or verapamil and the CYP3A4 inducer is rifampicin. 
     
     
         9 . The method of  claim 8  that comprises treating the patient for Non-24-Hour Sleep-Wake Disorder. 
     
     
         10 . The method of  claim 9  wherein, if the patient is not being treated with fluvoxamine or rifampicin or if treatment with fluvoxamine or rifampicin (or both) is discontinued, then the patient is treated by oral administration of tasimelteon at 20 mg/day prior to bedtime.