Armodafinil 200mg Tablets
It is used to treat a lot of sleepiness that may happen with sleep apnea, narcolepsy, or shift work problems.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Wakefulness-promoting agent
Pharmacologic Class
Atypical central nervous system stimulant
Pregnancy Category
Category C
FDA Approved
Jun 2007
DEA Schedule
Schedule IV
Overview
What is this medicine?
Armodafinil is a medication used to help people stay awake and alert. It's prescribed for conditions like narcolepsy, obstructive sleep apnea (when used with other treatments), and shift work sleep disorder. It works by affecting certain chemicals in your brain to promote wakefulness.
How to Use This Medicine
Taking Your Medication Correctly
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines. You can take this medication with or without food, but keep in mind that taking it with food may delay its onset of action.
If you're taking this medication to manage shift work sleep disorder, take it 1 hour before your work shift starts. For conditions like narcolepsy, sleep apnea, or other health issues, take your daily dose in the morning. To minimize the risk of sleep disturbances, avoid taking this medication late in the day.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children or pets can access it. Keep it in a secure, locked location to prevent unauthorized use. Dispose of unused or expired medication responsibly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist or look into local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to your bedtime, skip the missed dose and resume your regular schedule the next day. Avoid taking two doses at the same time or taking extra doses to make up for the missed one.
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines. You can take this medication with or without food, but keep in mind that taking it with food may delay its onset of action.
If you're taking this medication to manage shift work sleep disorder, take it 1 hour before your work shift starts. For conditions like narcolepsy, sleep apnea, or other health issues, take your daily dose in the morning. To minimize the risk of sleep disturbances, avoid taking this medication late in the day.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children or pets can access it. Keep it in a secure, locked location to prevent unauthorized use. Dispose of unused or expired medication responsibly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about the best way to dispose of your medication, consult your pharmacist or look into local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to your bedtime, skip the missed dose and resume your regular schedule the next day. Avoid taking two doses at the same time or taking extra doses to make up for the missed one.
Lifestyle & Tips
- Take Armodafinil exactly as prescribed by your doctor. Do not take more or less, or more often than prescribed.
- For narcolepsy or sleep apnea, take it in the morning. For shift work sleep disorder, take it about an hour before your work shift.
- Armodafinil is not a substitute for adequate sleep. Continue to practice good sleep hygiene (e.g., consistent sleep schedule, dark quiet room).
- Avoid alcohol while taking this medication, as it can worsen side effects.
- This medication can decrease the effectiveness of hormonal birth control (pills, patches, rings, implants). Use an alternative or additional method of birth control while taking Armodafinil and for one month after stopping it.
- Do not drive or operate heavy machinery until you know how Armodafinil affects you, as it may still cause dizziness or impair judgment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
150 mg or 250 mg orally once daily in the morning (for narcolepsy/OSA) or approximately 1 hour prior to shift (for SWSD)
Dose Range:
150 - 250 mg
Condition-Specific Dosing:
Narcolepsy:
150 mg or 250 mg orally once daily in the morning.
Obstructive Sleep Apnea (OSA):
150 mg or 250 mg orally once daily in the morning, adjunct to primary OSA treatment.
Shift Work Sleep Disorder (SWSD):
150 mg orally once daily approximately 1 hour prior to the start of the work shift.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness not established in pediatric patients <17 years of age)
Adolescent:
Not established (Safety and effectiveness not established in pediatric patients <17 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but caution advised. Consider lower doses.
Dialysis:
Not available (Armodafinil is not significantly dialyzable).
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Consider dose reduction (e.g., 75 mg daily).
Severe:
Consider dose reduction (e.g., 75 mg daily).
Confidence:
Medium
Pharmacology
Mechanism of Action
The precise mechanism of action is unknown. Armodafinil is thought to promote wakefulness by affecting various neurotransmitter systems in the brain, including dopamine, norepinephrine, serotonin, histamine, and orexin. It is believed to act as a weak, atypical dopamine reuptake inhibitor, but its wake-promoting effects differ from those of sympathomimetic agents.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated, but well-absorbed orally.
Tmax:
Approximately 2 hours (fasted state)
FoodEffect:
Food may delay Tmax by approximately 2-4 hours, but does not significantly affect overall bioavailability.
Distribution:
Vd:
Approximately 42 L (apparent volume of distribution)
ProteinBinding:
Approximately 60% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-15 hours (terminal half-life)
Clearance:
Not explicitly stated, but primarily hepatic.
ExcretionRoute:
Renal (approximately 80% as metabolites, <1% as unchanged drug)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours
PeakEffect:
Approximately 2-4 hours
DurationOfAction:
Approximately 12-15 hours (sufficient for a full waking day)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of heart problems: chest pain, fast, slow, or abnormal heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of depression or mood changes: suicidal thoughts, emotional instability, abnormal thinking, anxiety, or loss of interest in life
Hallucinations (seeing or hearing things that are not there)
Changes in behavior
Feeling nervous, excitable, or confused
Dark urine or yellow skin and eyes
Urination problems (difficulty starting or stopping urination, or changes in urine output)
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Muscle or joint pain
Diarrhea
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Upset stomach
Difficulty sleeping
* Dry mouth
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of heart problems: chest pain, fast, slow, or abnormal heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of depression or mood changes: suicidal thoughts, emotional instability, abnormal thinking, anxiety, or loss of interest in life
Hallucinations (seeing or hearing things that are not there)
Changes in behavior
Feeling nervous, excitable, or confused
Dark urine or yellow skin and eyes
Urination problems (difficulty starting or stopping urination, or changes in urine output)
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Muscle or joint pain
Diarrhea
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Upset stomach
Difficulty sleeping
* Dry mouth
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe rash, blistering, peeling skin, or sores in the mouth, nose, eyes, or genitals (stop taking and seek immediate medical attention)
- Swelling of the face, eyes, lips, tongue, or throat; difficulty breathing or swallowing (signs of allergic reaction)
- Chest pain, shortness of breath, fast or pounding heartbeat
- New or worsening anxiety, depression, agitation, aggression, or suicidal thoughts
- Hallucinations (seeing or hearing things that are not real), delusions (false beliefs), or other signs of psychosis
- Mania (unusual excitement, irritability, or uncontrolled thoughts)
- Unexplained fever, swollen lymph nodes, or yellowing of skin/eyes (jaundice)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of heart problems or heart valve issues, as these conditions may affect your ability to take this medication safely.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of heart problems or heart valve issues, as these conditions may affect your ability to take this medication safely.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is not a cure for sleep disorders and does not replace the need for sleep. Continue to follow your doctor's care and guidance.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. If you do not feel fully awake after taking this drug, you may need to avoid these activities as well. If you continue to feel sleepy after taking this medication, consult your doctor.
Be aware that this medication has the potential for abuse and dependence. Suddenly stopping or reducing the dose may increase the risk of seizures or withdrawal symptoms. Before decreasing the dose or stopping this medication, consult your doctor. If you experience a seizure or other severe side effects, seek immediate medical attention.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Avoid consuming alcohol while taking this medication. Before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult your doctor.
Limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.
There is a risk of mental or mood problems, including depression and suicidal thoughts, associated with this medication. In some cases, hospitalization has been necessary. If you have a history of mental or mood disorders, discuss this with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for use in children, as severe rashes have been reported in this population. Consult your doctor if you have any concerns.
When taking this medication, be aware that birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. Use an additional form of birth control, such as a condom, while taking this medication and for one month after the last dose.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. If you do not feel fully awake after taking this drug, you may need to avoid these activities as well. If you continue to feel sleepy after taking this medication, consult your doctor.
Be aware that this medication has the potential for abuse and dependence. Suddenly stopping or reducing the dose may increase the risk of seizures or withdrawal symptoms. Before decreasing the dose or stopping this medication, consult your doctor. If you experience a seizure or other severe side effects, seek immediate medical attention.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Avoid consuming alcohol while taking this medication. Before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult your doctor.
Limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.
There is a risk of mental or mood problems, including depression and suicidal thoughts, associated with this medication. In some cases, hospitalization has been necessary. If you have a history of mental or mood disorders, discuss this with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not approved for use in children, as severe rashes have been reported in this population. Consult your doctor if you have any concerns.
When taking this medication, be aware that birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. Use an additional form of birth control, such as a condom, while taking this medication and for one month after the last dose.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Insomnia
- Restlessness
- Disorientation
- Confusion
- Agitation
- Hallucinations
- Psychosis
- Nausea
- Diarrhea
- Tachycardia (fast heart rate)
- Bradycardia (slow heart rate)
- Hypertension (high blood pressure)
- Chest pain
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Treatment is generally supportive, including cardiovascular monitoring and management of agitation.
Drug Interactions
Major Interactions
- Hormonal contraceptives (e.g., ethinyl estradiol, levonorgestrel): Armodafinil can reduce their effectiveness due to CYP3A4 induction.
- Cyclosporine: Reduced cyclosporine levels due to CYP3A4 induction.
- Warfarin: Increased prothrombin time/INR due to CYP2C19 inhibition and CYP3A4 induction (complex interaction, requires close monitoring).
- Diazepam: Increased diazepam levels due to CYP2C19 inhibition.
- Phenytoin: Increased phenytoin levels due to CYP2C19 inhibition.
- Clomipramine: Increased clomipramine levels due to CYP2C19 inhibition.
Moderate Interactions
- Omeprazole: Increased omeprazole levels due to CYP2C19 inhibition.
- Tricyclic antidepressants (e.g., imipramine, desipramine): Potential for increased TCA levels.
- SSRIs (e.g., citalopram, escitalopram): Potential for altered SSRI levels.
- CYP3A4 substrates (e.g., midazolam, triazolam, simvastatin): Reduced levels of these drugs.
- CYP2C19 substrates (e.g., clopidogrel, voriconazole): Altered levels of these drugs.
Minor Interactions
- Alcohol: Concurrent use not recommended due to potential for impaired judgment and increased adverse effects.
- Monoamine Oxidase Inhibitors (MAOIs): Caution advised, though specific interactions not well-studied.
Monitoring
Baseline Monitoring
Cardiovascular assessment (BP, HR, ECG)
Rationale: To identify pre-existing cardiovascular conditions or arrhythmias that could be exacerbated.
Timing: Prior to initiation of therapy.
Psychiatric history
Rationale: To assess for history of psychosis, mania, or severe anxiety, which could be worsened.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly, especially during initial titration and periodically thereafter.
Target: Within patient's normal range; monitor for significant increases.
Action Threshold: Sustained clinically significant increases in BP/HR; consider dose reduction or discontinuation.
Psychiatric symptoms (e.g., anxiety, agitation, mania, psychosis, suicidal ideation)
Frequency: Regularly, especially during initial therapy and dose changes.
Target: Absence of new or worsening psychiatric symptoms.
Action Threshold: Emergence or worsening of psychiatric symptoms; consider dose reduction or discontinuation.
Skin rash/hypersensitivity reactions
Frequency: Patient education for self-monitoring, especially during initial weeks.
Target: Absence of rash.
Action Threshold: Any rash, especially if severe or accompanied by fever, lymphadenopathy, or facial swelling; discontinue immediately.
Sleep patterns and wakefulness
Frequency: Ongoing assessment.
Target: Improved wakefulness during desired hours, without excessive stimulation or insomnia.
Action Threshold: Lack of efficacy or development of insomnia; reassess dose or consider alternative.
Symptom Monitoring
- Skin rash, blistering, peeling, or sores (especially in mouth or eyes)
- Swelling of face, eyes, lips, tongue, or throat
- Difficulty breathing or swallowing
- Chest pain, palpitations, shortness of breath
- New or worsening anxiety, agitation, depression, or suicidal thoughts
- Hallucinations, delusions, or other psychotic symptoms
- Mania or hypomania
- Excessive sleepiness or insomnia
- Headache, dizziness, nausea
Special Patient Groups
Pregnancy
Armodafinil is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity based on animal studies.
Second Trimester:
Potential for developmental toxicity based on animal studies.
Third Trimester:
Potential for developmental toxicity based on animal studies.
Lactation
Armodafinil and its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., CNS stimulation, effects on sleep), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderate risk - possible adverse effects on the infant; use only if the benefit outweighs the risk).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients (under 17 years of age). Use is not recommended due to potential for serious adverse events, including psychiatric and dermatologic reactions.
Geriatric Use
Consider lower doses (e.g., 75 mg daily) in elderly patients, as they may have reduced clearance and increased sensitivity to the effects of Armodafinil. Monitor closely for adverse effects, particularly cardiovascular and psychiatric.
Clinical Information
Clinical Pearls
- Armodafinil is the R-enantiomer of modafinil, offering a longer half-life and potentially more sustained wakefulness compared to modafinil.
- It is not a substitute for sleep. Patients should be advised to maintain good sleep hygiene.
- Counsel female patients of childbearing potential about the reduced efficacy of hormonal contraceptives and the need for alternative birth control methods.
- Monitor for signs of serious rash (SJS, TEN, DRESS) and psychiatric symptoms (anxiety, mania, psychosis, suicidal ideation), especially early in treatment.
- Patients with pre-existing cardiovascular conditions should be carefully evaluated before starting Armodafinil and monitored closely.
- Abuse potential exists, though lower than traditional stimulants. Prescribe cautiously in patients with a history of substance abuse.
Alternative Therapies
- Modafinil (Provigil)
- Methylphenidate (Ritalin, Concerta)
- Amphetamine/Dextroamphetamine (Adderall)
- Solriamfetol (Sunosi)
- Pitolisant (Wakix)
- Sodium Oxybate (Xyrem, Xywav)
Cost & Coverage
Average Cost:
$300 - $600 per 30 tablets (150mg or 250mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand or non-preferred brand, depending on plan)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.