Method for minimizing disturbances in circadian rhythms of bodily performance and function

• US 4,665,086 A
• Filed: 09/26/1985
• Issued: 05/12/1987
• Est. Priority Date: 05/18/1983
• Status: Expired due to Term

• Current Assignee: Circadian Pharmaceuticals Aust Pty Ltd.
• Original Assignee: Monash University
• Inventors: Armstrong, Stuart, Short, Roger V.
• Primary Examiner(s): Friedman, Stanley J.
• Application Number:
  US06/780,337
• Time in Patent Office: 593 Days
• Field of Search: 514/416
• US Class Current: 514/416
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: C07D 209/16 Tryptamines

Abstract

Alleviating the effects of disturbances in circadian rhythms using melatonin.

Claims

1. A method of alleviating the effects on circadian rhythms of a rapid transition from a first time zone through at least a second time zone and a return to said first time zone in a human subject comprising administering orally to said subject melatonin at a time when the subject'"'"'s sleep phase should occur in said first time zone, the administration being repeated every 24 hours until the subject returns to said first time zone, the amount of melatonin being sufficient to alleviate the effects on circadian rhythms of a rapid transition from one time zone through at least a second time zone and a return to said first time zone.

5. A method according to any of claims 1, 2, 3 or 4 wherein the dose of melatonin administered is in the range 1 to 10 mg.

6. A method according to any one of claims 1, 2, 3 or 4 wherein the melatonin is combined with a pharmacologically acceptable carrier.

7. A method according to any one of claims 1, 2, 3 or 4 wherein the melatonin is orally administered together with at least a melatonin agonist.

8. A method according to any of claims 1, 2, 3 or 4 wherein the melatonin is replaced with a melatonin agonist.

9. A method according to any one of claims 1, 2, 3 or 4 wherein the melatonin is administered in a slow release form.

2. A method of entraining a temperature circadian rhythm to a predetermined cycle having a periodicity of 24 hours in a human subject comprising administering orally to said subject melatonin at a time which coincides with the downward point of the predetermined cycle, the amount of melatonin being sufficient to body temperature circadian rhythm to a predetermined cycle having a periodicity of 24 hours in a human subject.

3. A method of alleviating the effects of a disturbance in the endogenous melatonin circadian rhythm in a human subject comprising administering orally to said subject melatonin in an amount sufficient to alleviate the effects of a disturbance in the endogenous melatonin circadian rhythm in a human subject.

4. A method of entraining the endogenous melatonin circadian rhythm to a predetermined cycle having a periodicity of 24 hours in a human subject comprising administering orally to said subject melatonin at a time which coincides with the upward phase of the predetermined cycle, the amount of melatonin being sufficient to entrain the endogenous melatonin circadian rhythm to a predetermined cycle having a periodicity of 24 hours in a human subject.

10. A package containing melatonin in capsule form, 1-10 mg. per capsule, said package including instructions for administration thereof for the alleviation or prevention of ill effects associated with disturbance of circadian rhythms in a human subject.

11. A pharmaceutical capsule for the re-entrainment of disturbed circadian rhythms in a human subject, said capsule containing 1-10 mg. melatonin and a pharmaceutically acceptable diluent.

12. A pharmaceutical capsule for the re-entrainment of disturbed circadian rhythms in a human subject said capsule containing 1-10 mg. melatonin and a pharmaceutically acceptable diluent, said capsule being capable of releasing melatonin over a long period of time upon administration to a human.

13. A therapeutic method for re-entraining, in a human subject, short-term dissociated circadian rhythms or long-term desynchronized circadian rhythms, or for preventing, in a human subject, disruption of circadian rhythms following an environmental insult comprising orally administering melatonin as a chronobiotic to a human subject in need of such treatment, the amount of melatonin being sufficient to re-entrain short-term dissociated circadian rhythms, to re-entrain long-term desynchronized circadian rhythms, or to prevent disruption of circadian rhythms following an environmental insult.

14. A method according to claim 13 wherein the human subject has disturbed circadian rhythms.