US 12,239,680 B2
Sleep disorder compositions and treatments thereof
Mara Gordon, Bodega Bay, CA (US); Stewart Smith, Bodega Bay, CA (US); Stewart Washer, Stirling (AU); Patrizia Washer, Stirling (AU); and Harry Karelis, Perth (AU)
Assigned to Zelira Therapeutics Operations Pty Ltd, Perth (AU)
Filed by ZELIRA THERAPEUTICS OPERATIONS PTY LTD, Perth (AU)
Filed on Feb. 21, 2023, as Appl. No. 18/171,983.
Application 18/171,983 is a division of application No. 16/623,525, previously published as PCT/AU2018/050604, filed on Jun. 19, 2018.
Claims priority of application No. 2017902338 (AU), filed on Jun. 19, 2017; and application No. 2017904818 (AU), filed on Nov. 29, 2017.
Prior Publication US 2023/0270808 A1, Aug. 31, 2023
Int. Cl. A61K 36/185 (2006.01); A61K 9/00 (2006.01); A61K 31/01 (2006.01); A61K 31/045 (2006.01); A61K 31/05 (2006.01); A61K 31/352 (2006.01); A61P 25/20 (2006.01)
CPC A61K 36/185 (2013.01) [A61K 9/006 (2013.01); A61K 31/01 (2013.01); A61K 31/045 (2013.01); A61K 31/05 (2013.01); A61K 31/352 (2013.01); A61P 25/20 (2018.01)] 8 Claims
 
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:
Δ9-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.