Use of .gamma.-hydroxybutyrate for the stimulation of sleep-related secretion growth hormone and prolactin

• US 5,840,331 A
• Filed: 06/07/1995
• Issued: 11/24/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: ARCH Development Corporation (University of Chicago)
• Original Assignee: ARCH Development Corporation (University of Chicago)
• Inventors: Van Cauter, Eve, Scharf, Martin B.
• Primary Examiner(s): Bawa, Raj
• Application Number:
  US08/485,059
• Time in Patent Office: 1,266 Days
• Field of Search: 424/401, 424/451, 424/464, 514/962, 514/557, 514/923, 514/2
• US Class Current: 424/464
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 38/25 Growth hormone-releasing factor [GH-RF], i.e. somatoliberin

Abstract

Methods for reestablishing normal nocturnal growth hormone and prolactin secretion in adults with low slow-wave (deep) sleep are provided. In particular, methods are disclosed where γ-hydroxybutyrate is orally administered to subjects just prior to retiring.

Claims

1. A method for stimulating the release of growth hormone or prolactin in a human subject comprising the steps of:

(a) identifying a human subject having age-related suppression of growth hormone or prolactin release; and

then

(b) orally administering to said human subject, within one hour prior to retiring, a unit dose of γ

-hydroxybutyrate of about 2 to 5 g, said unit dose effective to increase the release of growth hormone or prolactin.

2. The method of claim 1, wherein said subject is at least forty years old.

3. The method of claim 2, wherein said subject is at least fifty years old.

4. The method of claim 3, wherein said subject is at least sixty years old.

5. The method of claim 2, wherein said subject is experiencing difficulty sleeping.

6. The method of claim 1, wherein said administration occurs one-half hour prior to retiring.

7. The method of claim 1, wherein said γ

-hydroxybutyrate is administered in a controlled release formulation.

8. The method of claim 1, further comprising coadministering at least one growth hormone secretagogue.

9. The method of claim 8, wherein said growth hormone secretagogue is growth hormone releasing peptide.

10. The method of claim 1, wherein the effective amount of γ

-hydroxybutyrate is 2.5 grams.

11. The method of claim 1, wherein the effective amount of γ

-hydroxybutyrate is 3.0 grams.

12. The method of claim 1, wherein the effective amount of γ

-hydroxybutyrate is 3.5 grams.

18. The method of claim 8, wherein said growth hormone secretagogue is a functional analog of growth hormone releasing peptide.

13. A method for stimulating the release of growth hormone or prolactin in a human subject comprising the steps of:

(a) identifying a human subject experiencing severe trauma or chronic illness; and

then

(b) orally administering to said human subject a unit dose of γ

-hydroxybutyrate of about 2 to 5 g, said unit dose effective to increase the release of growth hormone or prolactin.

14. The method of claim 13, wherein said subject is experiencing severe trauma.

15. The method of claim 14, wherein said severe trauma is burns.

16. The method of claim 14, wherein said severe trauma is surgery.

17. The method of claim 13, wherein said subject is experiencing chronic illness.

19. The method of claim 13, wherein the effective amount of γ

-hydroxybutyrate is 2.5 grams.

20. The method of claim 13, wherein the effective amount of γ

-hydroxybutyrate is 3.0 grams.

21. The method of claim 13, wherein the effective amount of γ

-hydroxybutyrate is 3.5 grams.