armodafinil

ar-mo-DAF-i-nil

Therapeutic Classification: central nervous system stimulants

REMS

To improve wakefulness in patients with excessive daytime drowsiness due to narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work disorder.

Produces CNS stimulation.

Therapeutic effects:

Improved wakefulness.

Absorption: Readily absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Mostly metabolized (partially by the CYP3A4 enzyme system; <10% excreted in urine).

Half-Life: 15 hr.

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	2 hr	unknown

Contraindicated in:

Hypersensitivity to modafinil or armodafinil.

Use Cautiously in:

Concurrent alcohol ingestion;
History of drug abuse, especially history of stimulant abuse;
Severe hepatic impairment (↓ dose recommended);
Recent MI or unstable angina;
Geri: Blood levels may by ↑ due to ↓ clearance (lower dose may be necessary);
OB: Safety not established;
Pedi: Safety and effectiveness not established.

CV: ↑BP

Derm: STEVENS-JOHNSON SYNDROME, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), rash, TOXIC EPIDERMAL NECROLYSIS

GI: nausea, dry mouth

Neuro: dizziness, headache, insomnia, aggression, anxiety, delusions, hallucinations, mania, SUICIDAL IDEATION

Misc: ANAPHYLACTOID REACTIONS AND ANGIOEDEMAALLERGIC REACTIONS INCLUDING

Drug-drug:

Concurrent use of CYP3A inhibitors, including ketoconazole and erythromycin may ↑ levels and effectiveness.
Concurrent use of CYP3A inducers, including carbamazepine, phenobarbital, and rifampin may ↓ levels and effectiveness.
May ↓ effectiveness of hormonal contraceptives, cyclosporine midazolam and triazolam.
Armodafinil may ↑ levels of phenytoin, diazepam, propranolol, omeprazole, and clomipramine.
Use cautiously with MAO inhibitors and other CNS stimulants.

PO (Adults ): Obstructive sleep apnea/hypopnea syndrome and narcolepsy: 150–250 mg once daily in the morning; Shift work sleep disorder: 150 mg once daily one hour before start of work.

(Generic available)

Tablets: 50 mg; 150 mg; 200 mg; 250 mg

Observe and document wakefulness and frequency of narcoleptic episodes.
If concurrent CPAP is used, assess CPAP adherence periodically during therapy.
Assess for psychiatric symptoms (mania, delusions, hallucinations, suicidal ideation, aggression) periodically during therapy; may require discontinuation.
Monitor BP periodically during therapy.
Monitor for skin reactions (rash, skin and mouth sores, blistering, ulceration) during therapy. Discontinue therapy at first sign of skin reactions.
Monitor for signs and symptoms of DRESS (fever, rash, lymphadenopathy, and/or facial swelling, associated with involvement of other organ systems (hepatitis, nephritis, hematologic abnormalities, myocarditis, myositis) during therapy. May resemble an acute viral infection. Eosinophilia is often present. Discontinue therapy if signs occur.

PO: Administer as a single dose in the morning.
- If used for shift work disorder, take daily dose 1 hr prior to start of work shift.

Instruct patient to take medication as directed. Advise patients that level of wakefulness may not return to normal. If used as an adjunct to CPAP, encourage patient to continue to use CPAP and other modalities. Inform patient that armodafinil does not take the place of getting enough sleep. Instruct patient to read Patient Information Leaflet prior to therapy.
Advise patient that sharing this medication with others, even those with the same symptoms, is dangerous and illegal.
Medication may impair judgment. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Instruct patient to notify health care professional immediately if rash, hives, mouth sores, blisters, peeling skin, swelling of face, eyes, lips, tongue, or throat, trouble swallowing or breathing, hoarse voice, or other allergic reactions occur.Patients should also notify health care professional if depression, anxiety, hallucinations, mania, thoughts of suicide or other mental problems (mania, delusions, hallucinations, suicidal ideation, aggression), or heart problems, including chest pain, occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Advise patient to avoid alcohol use during therapy.
Rep: Advise patient to use nonhormonal methods of contraception during and for 1 mo following discontinuation of therapy. Instruct patient to notify health care professional promptly if pregnancy is planned or suspected or if breastfeeding. Encourage pregnant patients to enroll in pregnancy registry by calling 1-866-404-4106.

Decrease in narcoleptic symptoms and an enhanced ability to stay awake. Evaluate effects of therapy periodically to determine long term usefulness.

Nuvigil

Schedule IV (C-IV)

NDC Code

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3090- Armodafinil
  - 0093-3090-56- 30 TABLET in 1 BOTTLE (0093-3090-56)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3092- Armodafinil
  - 0093-3092-56- 30 TABLET in 1 BOTTLE (0093-3092-56)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3093- Armodafinil
  - 0093-3093-56- 30 TABLET in 1 BOTTLE (0093-3093-56)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-3094- Armodafinil
  - 0093-3094-56- 30 TABLET in 1 BOTTLE (0093-3094-56)

0378- Mylan Pharmaceuticals Inc.
- 0378-3431- Armodafinil
  - 0378-3431-93- 30 TABLET in 1 BOTTLE, PLASTIC (0378-3431-93)

0378- Mylan Pharmaceuticals Inc.
- 0378-3432- Armodafinil
  - 0378-3432-93- 30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93)

0378- Mylan Pharmaceuticals Inc.
- 0378-3433- Armodafinil
  - 0378-3433-93- 30 TABLET in 1 BOTTLE, PLASTIC (0378-3433-93)

0591- Actavis Pharma, Inc.
- 0591-3856- Armodafinil
  - 0591-3856-30- 30 TABLET in 1 BOTTLE (0591-3856-30)

0781- Sandoz Inc
- 0781-8029- Armodafinil
  - 0781-8029-31- 30 TABLET in 1 BOTTLE (0781-8029-31)

0781- Sandoz Inc
- 0781-8037- Armodafinil
  - 0781-8037-31- 30 TABLET in 1 BOTTLE (0781-8037-31)

0781- Sandoz Inc
- 0781-8045- Armodafinil
  - 0781-8045-31- 30 TABLET in 1 BOTTLE (0781-8045-31)

0781- Sandoz Inc
- 0781-8053- Armodafinil
  - 0781-8053-31- 30 TABLET in 1 BOTTLE (0781-8053-31)

51991- Breckenridge Pharmaceutical, Inc.
- 51991-322- Armodafinil
  - 51991-322-90- 90 TABLET in 1 BOTTLE (51991-322-90)

51991- Breckenridge Pharmaceutical, Inc.
- 51991-323- Armodafinil
  - 51991-323-90- 90 TABLET in 1 BOTTLE (51991-323-90)

51991- Breckenridge Pharmaceutical, Inc.
- 51991-324- Armodafinil
  - 51991-324-90- 90 TABLET in 1 BOTTLE (51991-324-90)

55700- Lake Erie Medical DBA Quality Care Products LLC
- 55700-510- Armodafinil
  - 55700-510-30- 30 TABLET in 1 BOTTLE (55700-510-30)

59651- AUROBINDO PHARMA LIMITED
- 59651-047- ARMODAFINIL
  - 59651-047-30- 30 TABLET in 1 BOTTLE (59651-047-30)

61919- Direct_Rx
- 61919-562- ARMODAFINIL
  - 61919-562-30- 30 TABLET in 1 BOTTLE (61919-562-30)

61919- Direct_Rx
- 61919-770- Armodafinil
  - 61919-770-30- 30 TABLET in 1 BOTTLE (61919-770-30)

63459- Cephalon, Inc.
- 63459-205- Nuvigil
  - 63459-205-30- 30 TABLET in 1 BOTTLE (63459-205-30)

63459- Cephalon, Inc.
- 63459-215- Nuvigil
  - 63459-215-30- 30 TABLET in 1 BOTTLE (63459-215-30)

63459- Cephalon, Inc.
- 63459-215- Nuvigil
  - 63459-215-35- 5 BLISTER PACK in 1 CARTON (63459-215-35) > 7 TABLET in 1 BLISTER PACK (63459-215-07)

63459- Cephalon, Inc.
- 63459-220- Nuvigil
  - 63459-220-30- 30 TABLET in 1 BOTTLE (63459-220-30)

63459- Cephalon, Inc.
- 63459-220- Nuvigil
  - 63459-220-35- 5 BLISTER PACK in 1 CARTON (63459-220-35) > 7 TABLET in 1 BLISTER PACK (63459-220-07)

63459- Cephalon, Inc.
- 63459-225- Nuvigil
  - 63459-225-30- 30 TABLET in 1 BOTTLE (63459-225-30)

63459- Cephalon, Inc.
- 63459-225- Nuvigil
  - 63459-225-35- 5 BLISTER PACK in 1 CARTON (63459-225-35) > 7 TABLET in 1 BLISTER PACK (63459-225-07)

65862- Aurobindo Pharma Limited
- 65862-805- Armodafinil
  - 65862-805-05- 500 TABLET in 1 BOTTLE (65862-805-05)

65862- Aurobindo Pharma Limited
- 65862-805- Armodafinil
  - 65862-805-30- 30 TABLET in 1 BOTTLE (65862-805-30)

65862- Aurobindo Pharma Limited
- 65862-805- Armodafinil
  - 65862-805-60- 60 TABLET in 1 BOTTLE (65862-805-60)

65862- Aurobindo Pharma Limited
- 65862-806- Armodafinil
  - 65862-806-05- 500 TABLET in 1 BOTTLE (65862-806-05)

65862- Aurobindo Pharma Limited
- 65862-806- Armodafinil
  - 65862-806-30- 30 TABLET in 1 BOTTLE (65862-806-30)

65862- Aurobindo Pharma Limited
- 65862-806- Armodafinil
  - 65862-806-60- 60 TABLET in 1 BOTTLE (65862-806-60)

65862- Aurobindo Pharma Limited
- 65862-807- Armodafinil
  - 65862-807-05- 500 TABLET in 1 BOTTLE (65862-807-05)

65862- Aurobindo Pharma Limited
- 65862-807- Armodafinil
  - 65862-807-30- 30 TABLET in 1 BOTTLE (65862-807-30)

65862- Aurobindo Pharma Limited
- 65862-807- Armodafinil
  - 65862-807-60- 60 TABLET in 1 BOTTLE (65862-807-60)

65862- Aurobindo Pharma Limited
- 65862-998- Armodafinil
  - 65862-998-30- 30 TABLET in 1 BOTTLE (65862-998-30)

68180- Lupin Pharmaceuticals, Inc.
- 68180-569- Armodafinil
  - 68180-569-07- 60 TABLET in 1 BOTTLE (68180-569-07)

68180- Lupin Pharmaceuticals, Inc.
- 68180-571- Armodafinil
  - 68180-571-02- 500 TABLET in 1 BOTTLE (68180-571-02)

68180- Lupin Pharmaceuticals, Inc.
- 68180-571- Armodafinil
  - 68180-571-07- 60 TABLET in 1 BOTTLE (68180-571-07)

68180- Lupin Pharmaceuticals, Inc.
- 68180-572- Armodafinil
  - 68180-572-02- 500 TABLET in 1 BOTTLE (68180-572-02)

68180- Lupin Pharmaceuticals, Inc.
- 68180-572- Armodafinil
  - 68180-572-07- 60 TABLET in 1 BOTTLE (68180-572-07)

68180- Lupin Pharmaceuticals, Inc.
- 68180-573- Armodafinil
  - 68180-573-02- 500 TABLET in 1 BOTTLE (68180-573-02)

68180- Lupin Pharmaceuticals, Inc.
- 68180-573- Armodafinil
  - 68180-573-07- 60 TABLET in 1 BOTTLE (68180-573-07)

68788- Preferred Pharmaceuticals Inc.
- 68788-7176- Armodafinil
  - 68788-7176-3- 30 TABLET in 1 BOTTLE (68788-7176-3)

68788- Preferred Pharmaceuticals Inc.
- 68788-7176- Armodafinil
  - 68788-7176-6- 60 TABLET in 1 BOTTLE (68788-7176-6)

68788- Preferred Pharmaceuticals Inc.
- 68788-7176- Armodafinil
  - 68788-7176-9- 90 TABLET in 1 BOTTLE (68788-7176-9)

68788- Preferred Pharmaceuticals, Inc.
- 68788-7426- Armodafinil
  - 68788-7426-3- 30 TABLET in 1 BOTTLE (68788-7426-3)

68788- Preferred Pharmaceuticals, Inc.
- 68788-7426- Armodafinil
  - 68788-7426-6- 60 TABLET in 1 BOTTLE (68788-7426-6)

68788- Preferred Pharmaceuticals, Inc.
- 68788-7426- Armodafinil
  - 68788-7426-9- 90 TABLET in 1 BOTTLE (68788-7426-9)

71335- Bryant Ranch Prepack
- 71335-1193- Armodafinil
  - 71335-1193-1- 30 TABLET in 1 BOTTLE (71335-1193-1)

71335- Bryant Ranch Prepack
- 71335-1193- Armodafinil
  - 71335-1193-2- 28 TABLET in 1 BOTTLE (71335-1193-2)

71335- Bryant Ranch Prepack
- 71335-1308- Armodafinil
  - 71335-1308-1- 30 TABLET in 1 BOTTLE (71335-1308-1)

71335- Bryant Ranch Prepack
- 71335-1308- Armodafinil
  - 71335-1308-2- 28 TABLET in 1 BOTTLE (71335-1308-2)

72189- Direct_Rx
- 72189-041- ARMODAFINIL
  - 72189-041-30- 30 TABLET in 1 BOTTLE (72189-041-30)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Code ⬆