Armodafinil

What it is used for

Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).

Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

Side effects, and when to stop

Armodafinil tablets may cause serious side effects. Stop taking armodafinil tablets and call your doctor right away or get emergency help if you get any of the following:

• a serious rash or serious allergic reaction. ()
• mental (psychiatric) symptoms, including:
  • depression
  • feeling anxious
  • hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
  • an extreme increase in activity and talking (mania)
  • thoughts of suicide
  • aggressive behavior
  • other mental problems
• symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing.

The most common side effects of armodafinil tablets include:

• headache
• nausea
• dizziness
• trouble sleeping

These are not all the possible side effects of armodafinil tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store armodafinil tablets?

• Store armodafinil tablets at room temperature between 20° to 25°C (68° to 77°F).
• Keep armodafinil tablets and all medicines out of the reach of children.

General information about the safe and effective use of armodafinil tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use armodafinil tablets for a condition for which it was not prescribed. Do not give armodafinil tablets to other people, even if they have the same symptoms that you have. It may harm them and is against the law. You can ask your pharmacist or healthcare provider for information about armodafinil tablets that is written for health professionals. What are the ingredients in armodafinil tablets? Active Ingredient: armodafinil Inactive Ingredients:

croscarmellose sodium, lactose monohydrate, magnesium stearate, and povidone. For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876. This Medication Guide has been approved by the U.S. Food and Drug Administration. Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 04/2023

What to avoid

• Do not drive a car or do other dangerous activities until you know how armodafinil tablets affect you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.
• You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking armodafinil tablets.