Methods and compositions for improving sleep
View Patent ↗Compositions suitable for oral use (e.g., oral thin film) containing various excipients and a combination of melatonin, caryophyllene, GABA, L-theanine, and vitamin B 6 . Methods of using the composition, e.g., in the treatment of a sleeping disorder, as well as methods of manufacturing the composition are also included.
1. An oral thin film having a mass of about 110-130 mg, the thin film comprising:
(i) 1.5±0.5 mg N-acetyl-5-methoxy tryptamine (melatonin),
(ii) 15±5 mg (−)-β-caryophyllene (caryophyllene),
(iii) 7.5±3 mg 4-aminobutanoic acid (GABA),
(iv) 12±6 mg L-γ-glutamylethylamide (L-theanine),
(v) 3±2 mg pyridoxine (vitamin B6),
(vi) 29±15 mg in the aggregate of at least one of binder, thickening agent, and gelling agent,
(vii) 10±4 mg plasticizer,
(viii) 2±1 mg lipid,
(ix) 8±5 mg flavoring agent, and
(x) 8±5 mg sweetener.
2. The oral thin film of claim 1 , having the following dimensions: 44±4 mm×22±2 mm×0.12±0.01 mm.