Armodafinil - Dosage TABLET
Dosage & Administration
The recommended dosage of armodafinil tablets for each indication is as follows:
- OSA or Narcolepsy: 150 mg to 250 mg once a day in the morning. (2.1)
- SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift. (2.2)
- Hepatic Impairment: reduced dose in patients with severe hepatic impairment. (2.3, 12.3)
- Geriatric Patients: consider lower dose. (2.4, 12.3)
dosage in obstructive sleep apnea (osa) & narcolepsy
The recommended dosage of armodafinil tablets for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning.
In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose [see Clinical Pharmacology (12.3) and Clinical Studies (14.1, 14.2)].
dosage in shift work disorder (swd)
The recommended dosage of armodafinil tablets for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.
dosage modification in patients with severe hepatic impairment
use in geriatric patients
Consideration should be given to the use of lower doses and close monitoring in geriatric patients [see Use in Specific Populations (8.5)].
Dosage Form & Strengths
- 50 mg – round, white to off-white tablet with
- 150 mg – oval, white to off-white tablet with
- 200 mg – rounded, rectangular, white to off-white tablet with
- 250 mg – oval, white to off-white tablet with
Tablets: 50 mg, 150 mg, 200 mg, and 250 mg. (3)
Fatal overdoses involving modafinil alone or involving armodafinil or modafinil in combination with other drugs have been reported in the postmarketing setting. Symptoms most often accompanying armodafinil or modafinil overdose, alone or in combination with other drugs, have included anxiety, dyspnea, insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.
No specific antidote exists for the toxic effects of an armodafinil overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.
Storage & Handling
Armodafinil Tablets are available as follows:
50 mg: Each round, white to off-white tablet is debossed with
on one side and "205" on the other.
150 mg: Each oval, white to off-white tablet is debossed with
on one side and "215" on the other.
200 mg: Each rounded, rectangular, white to off-white tablet is debossed with
on one side and "220" on the other.
250 mg: Each oval, white to off-white tablet is debossed with
on one side and "225" on the other.
NDC 55700-510-30 – Bottles of 30
Store at 20o ‑ 25o C (68o ‑ 77o F).