Controlled transdermal administration of melatonin

A device for the transdermal administration, at a therapeutically effective rate, of melatonin, which device comprises:

• (a) a first reservoir comprising a therapeutically effective amount of melatonin and a skin permeation-enhancing amount of a monofilyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%;
• (b) a second reservoir comprising an excess of the permeation enhancer and being substantially free of melatonin;
• (c) a rate-controlling membrane between the first reservoir and the second reservoir;
• (d) a backing impermeable to melatonin on the skin-distal surface of the second reservoir;
• and
• (e) means for maintaining the first and second reservoirs in melatonin- and permeation enhancer-transmitting relation with the skin.

A method for providing uninterrupted sleep to a person having fragmented sleep, the method comprising the step of placing a melatonin transdermal delivery device onto the skin of a person prior to the bedtime of the person, the melatonin transdermal delivery device comprising:

• (a) a reservoir comprising melatonin in an amount sufficient to provide a hypnotic effect for a predetermined period of time and a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51% in a skin permeation-enhancing amount;
• (b) an impermeable backing on the skin-distal surface of the reservoir;
• and
• (c) means for maintaining the reservoir in melatonin- and permeation enhancer-transmitting relation with the skin.

A method for providing uninterrupted sleep to a person having fragmented sleep, the method comprising the step of placing a melatonin transdermal delivery device onto the skin of a person prior to the bedtime of the person, the melatonin transdermal delivery device comprising:

• (a) a first reservoir comprising melatonin in an amount sufficient to provide a hypnotic effect for a predetermined period of time and a monoglyceride or mixture of monoglycerides of fatty acids with a itotal monoesters content of at least 51% in a skin permeation-enhancing amount;
• (b) a second reservoir comprising an excess of the permeation enhancer and substantially free of melatonin;
• (c) a rate-controlling membrane between the first reservoir and the second reservoir;
• (d) an impermeable backing on the skin-distal surface of the second reservoir;
• and
• (e) means for maintaining the first and second reservoir in melatonin- and permeation enhancer-transmitting relation with the skin.

A device for the transdermal administration, at a therapeutically effective rate, of melatonin, which device comprises:

• (a) a reservoir comprising a therapeutically effective amount of melatonin and a skin permeation-enhancing amount of a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%;
• (b) a backing impermeable to the melatonin on the skin-distal surface of the reservoir;
• and
• (c) means for maintaining the reservoir in melatonin- and permeation enhancer-transmitting relation with the skin;
• wherein the melatonin is administered through the skin at a rate of about 0.1-200 .mu.g/hr for a predetermined period of time.

A device for the transdermal administration, at a therapeutically effective rate, of melatonin, which device comprises:

• (a) a first reservoir comprising a therapeutically effective amount of melatonin and a skin permeation-enhancing amount of a monoglyceride or mixture of monoglycerides of fatty acids with a total monoesters content of at least 51%;
• (b) a second reservoir comprising an excess of the permeation enhancer and being substantially free of melatonin;
• (c) a rate-controlling membrane between the first reservoir and the second reservoir;
• (d) a backing impermeable to melatonin on the skin-distal surface of the second reservoir;
• and
• (e) means for maintaining the first and second reservoirs in melatonin- and permeation enhancer-transmitting relation with the skin;
• wherein the melatonin is administered through the skin at a rate of about 0.1-200 .mu.g/hr for a predetermined period of time.