Granted Patent B2

US 12,239,680 · App. 18/171,983 · Granted Mar 4, 2025

Inventors: Mara Gordon (Bodega Bay, CA); Stewart Smith (Bodega Bay, CA); Stewart Washer (Stirling, AU); Patrizia Washer (Stirling, AU); Harry Karelis (Perth, AU)

Assignee: Zelira Therapeutics Operations Pty Ltd

A61K36/185A61K9/006A61K31/01A61K31/045A61K31/05A61K31/352A61P25/20

Abstract

Claims (27)

1. A method for treating insomnia in a human in need thereof comprising:

administering to the human in need thereof a therapeutically effective amount of a pharmaceutical composition including a Cannabis extract and sunflower oil to effectively treat the insomnia in said human in need thereof,

wherein the Cannabis extract is present in an amount of from 0.5% to 5% by weight of the composition and the sunflower oil is present in an amount of from 95% to 99.5% by weight of the composition, wherein the Cannabis extract includes a cannabinoid fraction and a terpene fraction;

the cannabinoid fraction including:

Δ 9 -Tetrahydrocannabinol (THC) in an amount in the range from 70% to 95% by weight of the Cannabis extract,

Cannabidiol (CBD) in an amount in the range from 2% to 5% by weight of the Cannabis extract, and

Cannabinol (CBN) in an amount in the range from 5% to 10% by weight of the Cannabis extract,

wherein a weight ratio of CBN:CBD is in a range of from about 1:1 to about 10:1;

the terpene fraction is present in an amount of from 3% by weight to 10% by weight of the Cannabis extract, and wherein the terpene fraction includes linalool and beta-myrcene; and

wherein the amount of pharmaceutical composition administered provides:

THC in an amount of from 5 mg/day to 25 mg/day;

CBD in an amount of from 0.1 mg/day to 5 mg/day; and

CBN in an amount of from 0.1 mg/day to 5 mg/day.

2. The method of claim 1 , wherein the terpene fraction contains linalool in an amount of from about 20% to about 45% by weight of the terpene fraction.

3. The method of claim 1 , wherein the terpene fraction contains beta-myrcene in an amount of from about 20% to about 45% by weight of the terpene fraction.

4. The method of claim 1 , wherein the terpene fraction includes nerolidol.

5. The method of claim 1 , wherein the pharmaceutical composition includes:

THC at 18-22 mg/ml;

Nat 1-3 mg/ml;

CBD at 0.5-1.5 mg/ml;

linalool at 0.5 mg/ml or less;

beta-myrcene at 0.5 mg/ml or less;

nerolidol at 0.25 mg/ml or less; and

sunflower oil.

6. The method of claim 1 , wherein the pharmaceutical composition is administered once per day.

7. The method of claim 1 , wherein the pharmaceutical composition is administered within about 1.5 hours prior to sleep.

8. The method of claim 1 , wherein the pharmaceutical composition is administered sublingually.

Assignments (2)

Priority Claims (2)

Continuity (2)

References Cited (53)