Armodafinil

Armodafinil reduces extreme sleepiness due to narcolepsy and other sleep disorders, such as periods of stopped breathing during sleep (obstructive sleep apnea). It is also used to help you stay awake during work hours if you have a work schedule that keeps you from having a normal sleep routine (shift work sleep disorder).

Armodafinil does not cure these sleep disorders and may not get rid of all your sleepiness. Armodafinil does not take the place of getting enough sleep. It should not be used to treat tiredness or hold off sleep in people who do not have a sleep disorder.

It is not known how armodafinil works to keep you awake. It is thought to work by affecting certain substances in the brain that control the sleep/wake cycle.

Armodafinil is available under the following different brand names: Nuvigil.

Dosage Forms and Strengths

Tablet: Schedule IV

• 50 mg
• 150 mg
• 200 mg
• 250 mg

Dosage Considerations – Should be Given as Follows:

Obstructive Sleep Apnea/Hypopnea Syndrome

• 150-250 mg orally in the morning

Narcolepsy

• 150-250 mg orally in the morning

Shift Work Sleep Disorder

• 150 mg orally once/day 1 hour prior to patient's work shift

Limitation of Use

• In obstructive sleep apnea, indicated to treat excessive sleepiness and not as treatment for the underlying obstruction

Dosing Modifications

•  Hepatic impairment: Reduce dose
•  Renal impairment: Safety and efficacy not established
•  Pediatric: Safety and efficacy not established
•  Geriatric: Consider lower initial dose

Common side effects of Armodafinil include:

• Headache
• Nausea
• Dry mouth
• Dizziness
• Anxiety
• Diarrhea
• Difficulty sleeping (insomnia)
• Rash
• Depression
• Indigestion/heartburn
• Fatigue
• Palpitations
• Agitation
• Loss of appetite
• Attention disturbances
• Contact dermatitis
• Shortness of breath
• Excessive sweating
• Nervousness
• Numbness and tingling
• Fever
• Upset stomach

Less common ide effects of armodafinil include:

• Skin swelling
• Difficulty swallowing
• Bronchospasm
• Reversible psychosis

Serious side effects of armodafinil include:

• Fast/pounding/irregular heartbeat
• Mental/mood changes (such as agitation, confusion, depression, hallucinations, rare thoughts of suicide)

Postmarketing side effects of armodafinil reported include:

• Aggression
• Mouth Sores
• Persistent sleepiness

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of armodafinil include:

• cobimetinib
• isocarboxazid
• linezolid
• ombitasvir/paritaprevir/ritonavir
• phenelzine
• selegiline transdermal
• tranylcypromine

Armodafinil has serious interactions with at least 35 different drugs.

Armodafinil has moderate interactions with at least 287 different drugs.

Armodafinil has mild interactions with at least 159 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains armodafinil. Do not take Nuvigil if you are allergic to armodafinil or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to modafinil, armodafinil, or other ingredients

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Armodafinil?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Armodafinil?"

Cautions

• Not recommended in patients with angina, cardiac ischemia, recent history of myocardial infarction, left ventricular hypertrophy, or mitral valve prolapse
• Use caution in patients with history of left ventricular hypertrophy/mitral valve prolapse who have had mitral valve prolapse syndrome when previously receiving central nervous system (CNS) stimulants; consider increased monitoring
• Use caution in severe hepatic impairment and the elderly
• History of depression, psychosis, mania; consider discontinuing armodafinil if psychiatric symptoms develop
• Consider dose adjustment of CYP3A4/5 substrate medications
• May reduce effectiveness of steroidal contraceptives 1 month after discontinuation of drug therapy
• If used adjunctively with continuous positive airway pressure (CPAP), periodic assessment of CPAP compliance is necessary
• Rash resulting in discontinuation reported; rashes included 1 case of possible Stevens-Johnson syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction/ Drug Rash with Eosinophilia and Systemic Symptoms (DRESS); rare cases of serious or life-threatening rash, toxic epidermal necrolysis (TEN) reported in adults and children
• Serious rash requiring hospitalization and discontinuation of treatment has been reported; discontinue at first sign of serious rash
• Discontinue therapy if symptoms suggest angioedema or anaphylaxis
• Skin and mouth sores, blistering, and ulceration reported

Pregnancy and Lactation

• There is limited available data in pregnant women are insufficient to inform about drug-associated risk of adverse pregnancy outcomes while using armodafinil
• Intrauterine growth restriction and spontaneous abortion has been reported in association with armodafinil and modafinil
• Although the pharmacology of armodafinil is not identical to that of sympathomimetic amines, armodafinil shares some pharmacologic properties with this class
• Sympathomimetics have been associated with intrauterine growth restriction and spontaneous abortions
• The effectiveness of hormonal contraceptives may be reduced up to for one month after discontinuation of armodafinil therapy
• Advise women who using a hormonal method of contraception to use additional barrier method or alternative non-hormonal method of contraception during treatment and for one month after discontinuation of treatment
• There are no data on the presence of armodafinil or metabolite in human milk, the effects on breastfed infant, or the effect of this drug on milk production
• Modafinil was present in rat milk when animals were dosed during the lactation period
• The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for armodafinil and any potential adverse effects on the breastfed child from armodafinil or from the underlying maternal condition
• It is unknown if armodafinil is excreted in milk; use caution if breastfeeding