Administration of hypocretin-1 for treatment of narcolepsy
View Patent ↗The invention provides compositions and methods for treatment of sleep disorders. Such methods entail administering to the patient a therapeutically effective dosage regime of an agonist of a hypocretin 1 (Hcrt-1) receptor to a peripheral tissue of the patient, and monitoring the condition of the patient responsive to the treatment, wherein the monitoring indicates a reduction in excessive daytime sleepiness (EDS) and an improvement in nighttime sleep consolidation and architecture. The methods are particularly useful for prophylactic and therapeutic treatment of one or more sleep disorders in a patient.
1. A method of treating a patient having narcolepsy or cataplexy comprising:
peripherally administering a therapeutically effective dosage regime of hypocretin-1 to the patient in need thereof, whereby the hypocretin-1 crosses the blood brain barrier of the patient and thereby treats the narcolepsy or cataplexy in the patient.
2. The method of claim 1 , wherein the hypocretin-1 is a natural human hypocretin-1.
3. The method of claim 1 , wherein the patient experiences a reduction in excessive daytime sleepiness responsive to administering the therapeutically effective dosage regime.
4. The method of claim 1 , wherein the patient experiences an improvement in nighttime sleep consolidation and architecture responsive to the treatment.
5. The method of claim 1 , further comprising monitoring the condition of the patient responsive to administering the therapeutically effective dosage regime.
6. The method of claim 1 , wherein the patient is a mammal.
7. The method of claim 1 , wherein the hypocretin-1 is peripherally administered to the patient by intravenous delivery, intraperitoneal delivery, transdermal delivery, intramuscular delivery, subcutaneous delivery, inhalation, or oral delivery.
8. A method of treating narcolepsy/cataplexy comprising:
peripherally administering to a patient having narcolepsy or cataplexy a therapeutically effective dosage regime of hypocretin-1, and
monitoring the condition of the patient responsive to the treatment, wherein the monitoring indicates a reduction in excessive daytime sleepiness (EDS) and an improvement in nighttime sleep consolidation and architecture.
9. The method of claim 8 , wherein the patient is a mammal.
10. The method of claim 9 , wherein the mammal is human.
11. The method of claim 8 , wherein the hypocretin-1 is free of a label.
12. The method of claim 8 , wherein the dosage in the regime is separated by at least 12 hours.
13. The method of claim 8 , wherein the dosage in the regime is separated by at least 24 hours.
14. The method of claim 8 , wherein each dosage is 0.3 to about 10 μg/kg of hypocretin-1.
15. The method of claim 8 , wherein the dosage regime is peripherally administered to the patient by intravenous delivery, intraperitoneal delivery, transdermal delivery, intramuscular delivery, subcutaneous delivery, inhalation, or oral delivery.
16. The method of claim 8 , wherein the monitoring is selected from the group consisting of conducting nocturnal polysomnogram (PSG), Multiple Sleep Latency Test (MLST), Epworth Sleepiness Scale (EPS) questionnaire, Maintenance of Wakefulness Test (MWT), pupilography, electroencephalograms, electrocephalographic spectral analysis, actigraphy, and maintaining a log of incidence of cataplexy including their number, severity and duration.
17. The method of claim 8 , wherein the method further comprises identifying a patient in need of treatment for one or more sleep disorders prior to administration of said therapeutically effective dosage regime.
18. The method of claim 8 , wherein hypocretin-1 is administered together with a pharmaceutically acceptable carrier as a pharmaceutical composition.