Low-dose doxepin formulations and methods of making and using the same
The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
1. A method of treating insomnia, the method comprising administering to a patient in need thereof a pharmaceutical composition comprising about 0.5 to about 7 mg of doxepin, or a pharmaceutically acceptable salt thereof, and about 92% to about 99.8% w/w silicified microcrystalline cellulose.
2. The method of claim 1 , wherein administering the composition provides a plasma concentration of at least 0.05 ng/mL doxepin within a time frame of not more than about 90 minutes.
3. The method of claim 1 , wherein the composition further comprises about 0.1 to about 1.5% w/w colloidal silicon dioxide.
4. The method of claim 1 , wherein the composition further comprises about 0.25 to about 1.5% w/w magnesium stearate.
5. The method of claim 1 , wherein the composition comprises about 0.8 to about 2 mg of doxepin or a pharmaceutically acceptable salt thereof.
6. The method of claim 1 , wherein the composition comprises about 2.5 to about 4 mg of doxepin or a pharmaceutically acceptable salt thereof.
7. The method of claim 1 , wherein the composition comprises about 3 mg of doxepin or a pharmaceutically acceptable salt thereof.
8. The method of claim 1 , wherein the composition comprises about 5.5 to about 7 mg of doxepin or a pharmaceutically acceptable salt thereof.
9. The method of claim 1 , wherein the composition comprises about 6 mg of doxepin or a pharmaceutically acceptable salt thereof.
10. The method of claim 1 , wherein the composition comprises comprises about 94% to about 98.5% w/w silicified microcrystalline cellulose.
11. The method of claim 1 , wherein the insomnia is a chronic insomnia.
12. The method of claim 1 , wherein the insomnia is a non-chronic insomnia.
13. The method of claim 1 , wherein the insomnia is a non-chronic insomnia.
14. The method of claim 1 , wherein the patient suffers from difficulties in sleep onset.
15. The method of claim 1 , wherein the patient suffers from difficulties in sleep maintenance.
16. The method of claim 1 , wherein the patient suffers from difficulties in sleep duration.
17. The method of claim 1 , wherein the patient suffers from difficulties in sleep efficiency.
18. The method of claim 1 , wherein the patient suffers from difficulties in premature early-morning awakening.
19. The method of claim 1 , wherein the composition comprises a tablet.
20. The method of claim 1 , wherein administering the composition provides a plasma concentration of at least 0.1 ng/mL doxepin within a time frame of not more than about 60 minutes.