目前針對睡眠症或是猝睡症或是嗜睡症所開發的藥品，無法痊癒症狀
Oral route
1.3.1.A.1 Narcolepsy, improve wakefulness in patients with excessive sleepiness
1.3.1.A.2 Obstructive sleep apnea, improve wakefulness in patients with excessive sleepiness; Adjunct
1.3.1.A.3 Shift work sleep disorder, improve wakefulness in patients with excessive sleepinessDosage in Hepatic Insufficiency
Drug Concentration Levels
Pregnancy ：C
Mechanism of Action
Armodafinil, an alpha1-adrenoceptor agonist, is the R enantiomer of modafinil . The exact mechanism that armodafinil produces wakefulness is unknown. The wake-promoting actions of armodafinil are similar to that of sympathomimetic amines despite differences in their pharmacologic profiles
ARMODAFINIL
FDA Approved Indications1) Narcolepsy, improve wakefulness in patients with excessive sleepiness
2) Obstructive sleep apnea, improve wakefulness in patients with excessive sleepiness; Adjunct
3) Shift work sleep disorder, improve wakefulness in patients with excessive sleepiness
2) Obstructive sleep apnea, improve wakefulness in patients with excessive sleepiness; Adjunct
3) Shift work sleep disorder, improve wakefulness in patients with excessive sleepiness
Oral route
Narcolepsy, improve wakefulness in patients with excessive sleepiness
Obstructive sleep apnea, improve wakefulness in patients with excessive sleepiness; Adjunct
Shift work sleep disorder, improve wakefulness in patients with excessive sleepiness
1.3.1.A.1 Narcolepsy, improve wakefulness in patients with excessive sleepiness
a) The recommended dose of armodafinil for patients with excessive sleepiness associated with narcolepsy is 150 milligrams (mg) or 250 mg given as a single dose in the morning (Prod Info NUVIGIL(TM) oral tablets, 2007).
1.3.1.A.2 Obstructive sleep apnea, improve wakefulness in patients with excessive sleepiness; Adjunct
a) The recommended dose of armodafinil for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) is 150 milligrams (mg) or 250 mg given as a single dose in the morning in conjunction with standard treatment(s). Doses higher than 150 mg per day do not necessarily confer additional benefits (Prod Info NUVIGIL(TM) oral tablets, 2007).
1.3.1.A.3 Shift work sleep disorder, improve wakefulness in patients with excessive sleepiness
a) The recommended dose of armodafinil for patients with excessive sleepiness associated with shift work sleep disorder is 150 milligrams (mg) given orally once a day approximately 1 hour prior to the start of work shift (Prod Info NUVIGIL(TM) oral tablets, 2007).
A) For patients with severe hepatic impairment, the dose of armodafinil should be reduced. The oral clearance of modafinil was reduced by about 60%, and the steady state concentration was doubled in 9 patients with cirrhosis of the liver (3 had stage B or B+ cirrhosis, 6 had stage C or C+ cirrhosis per the Child-Pugh score criteria) (Prod Info NUVIGIL(TM) oral tablets, 2007).
Drug Concentration Levels
A) Peak Concentration
1) Oral: 1.97 mcg/mL (100 mg) to 6.37 mcg/mL (300 mg) (Dinges et al, 2006).
B) Time to Peak Concentrationa) The Cmax of armodafinil was 1.97 mcg/mL (100 mg) to 6.37 mcg/mL (300 mg) in a randomized, double-blind, placebo-controlled, parallel group study of single oral doses in healthy young men (Dinges et al, 2006).
| Armodafinil | ||||
| Dose | 300 mg | 200 mg | 150 mg | 100 mg |
| N | n=18 | n=17 | n=18 | n=18 |
| Mean Cmax (mcg/mL, (standard deviation)) | 6.37 +/- 0.88 | 4.04 +/- 0.69 | 2.99 +/- 0.41 | 1.97 +/- 0.25 |
1) Oral: 2 hours (Prod Info NUVIGIL(TM) oral tablets, 2007).
C) Steady Statea) The time to peak concentration was attained at approximately 2 hours in the fasted state (Prod Info NUVIGIL(TM) oral tablets, 2007).
b) The Tmax of armodafinil was 5 hours (300 mg) to 6.5 hours (150 mg) in a randomized, double-blind, placebo-controlled, parallel group study of single oral doses in healthy young men (Dinges et al, 2006).
b) The Tmax of armodafinil was 5 hours (300 mg) to 6.5 hours (150 mg) in a randomized, double-blind, placebo-controlled, parallel group study of single oral doses in healthy young men (Dinges et al, 2006).
| Armodafinil | ||||
| Dose | 300 mg | 200 mg | 150 mg | 100 mg |
| N | n=18 | n=17 | n=18 | n=18 |
| Median Tmax (hours, (range)) | 5 (3 to 12) | 6 (2 to 8) | 6.5 (3 to 11) | 5.5 (0.5 to 11) |
1) approximately 7 days (Prod Info NUVIGIL(TM) oral tablets, 2007)
D) Area Under the Curvea) Steady state of armodafinil was reached within 7 days of dosing (Prod Info NUVIGIL(TM) oral tablets, 2007).
1) 20.1 mcg X hr/mL (100 mg) to 66.2 mcg X hr/mL (300 mg) (Dinges et al, 2006).
a) The AUC of armodafinil increased in proportion to oral doses in the range of 100 mg to 300 mg in a randomized, double-blind, placebo-controlled, parallel group study of single oral doses in healthy young men (Dinges et al, 2006).
| Armodafinil | ||||
| Dose | 300 mg | 200 mg | 150 mg | 100 mg |
| N | n=18 | n=17 | n=18 | n=18 |
| Mean AUC (mcg X hr/mL, (standard deviation)) | 66.2 +/- 8.5 | 42.4 +/- 7.2 | 29.9 +/- 4.6 | 20.1 +/- 3.5 |
Pregnancy ：C
Mechanism of Action
Armodafinil, an alpha1-adrenoceptor agonist, is the R enantiomer of modafinil . The exact mechanism that armodafinil produces wakefulness is unknown. The wake-promoting actions of armodafinil are similar to that of sympathomimetic amines despite differences in their pharmacologic profiles
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