Armodafinil 150mg 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
Eugeroic; Dopamine Reuptake Inhibitor (atypical)
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 who have excessive sleepiness due to conditions like narcolepsy, obstructive sleep apnea, or shift work disorder. It helps you stay awake and alert during the day or your work shift.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. 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 help with shift work sleep problems, take it 1 hour before your work shift starts. For narcolepsy, sleep apnea, or other conditions, take it in the morning if you're taking it once daily. To avoid disrupting your sleep patterns, 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 the bathroom. Keep it in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to safeguard your medication. Remember to keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to bedtime, skip the missed dose and resume your regular schedule the next day. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. 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 help with shift work sleep problems, take it 1 hour before your work shift starts. For narcolepsy, sleep apnea, or other conditions, take it in the morning if you're taking it once daily. To avoid disrupting your sleep patterns, 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 the bathroom. Keep it in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to safeguard your medication. Remember to keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to bedtime, skip the missed dose and resume your regular schedule the next day. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Armodafinil is not a substitute for adequate sleep. Continue to practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment).
- Avoid alcohol while taking armodafinil, as it can worsen side effects.
- Be cautious when driving or operating machinery until you know how armodafinil affects you, as it may still cause dizziness or impair judgment.
- If you are taking hormonal birth control, armodafinil can make it less effective. Discuss alternative or additional birth control methods with your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
150 mg once daily in the morning for Narcolepsy or Obstructive Sleep Apnea (OSA). For Shift Work Disorder (SWD), 150 mg approximately 1 hour prior to the start of the work shift.
Dose Range:
150 - 250 mg
Condition-Specific Dosing:
Narcolepsy:
150 mg or 250 mg once daily in the morning.
Obstructive Sleep Apnea (OSA):
150 mg or 250 mg once daily in the morning.
Shift Work Disorder (SWD):
150 mg approximately 1 hour prior to the start of the work shift.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; consider lower doses (e.g., 75 mg).
Dialysis:
Not well studied; use with caution.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Reduce dose by half (e.g., 75 mg once daily).
Confidence:
High
Pharmacology
Mechanism of Action
The precise mechanism of action of armodafinil is unknown. It is thought to produce its wakefulness-promoting effects by increasing dopaminergic and noradrenergic signaling in the brain, and by increasing histamine and orexin levels. It is a selective, atypical dopamine reuptake inhibitor, but its effects are not identical to those of sympathomimetic agents.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified, but well absorbed.
Tmax:
Approximately 2 hours (fasted state).
FoodEffect:
Food may delay Tmax by 2-4 hours but does not significantly affect the overall extent of absorption (AUC).
Distribution:
Vd:
Approximately 42 L (apparent volume of distribution).
ProteinBinding:
Approximately 60% (primarily to albumin).
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-15 hours.
Clearance:
Not explicitly quantified as a single rate, but primarily hepatic metabolism.
ExcretionRoute:
Renal (urine) - approximately 80% as metabolites, less than 1% as unchanged drug.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 1-2 hours.
PeakEffect:
Approximately 2-4 hours.
DurationOfAction:
Approximately 12-15 hours.
Confidence:
High
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, trouble 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, lack of interest in life, hallucinations (seeing or hearing things that are not there), changes in behavior, nervousness, excitability, confusion, dark urine, yellow skin or eyes, or changes in urination patterns (difficulty passing urine or changes in urine output).
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Muscle or joint pain, diarrhea, or severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and other serious reactions, which can be life-threatening and may also affect internal organs).
If you experience any of the following severe skin reaction symptoms, seek medical help immediately: 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. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness or headache
Upset stomach
Trouble 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, trouble 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, lack of interest in life, hallucinations (seeing or hearing things that are not there), changes in behavior, nervousness, excitability, confusion, dark urine, yellow skin or eyes, or changes in urination patterns (difficulty passing urine or changes in urine output).
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Muscle or joint pain, diarrhea, or severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and other serious reactions, which can be life-threatening and may also affect internal organs).
If you experience any of the following severe skin reaction symptoms, seek medical help immediately: 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. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness or headache
Upset stomach
Trouble 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:
- Any skin rash, especially if severe, blistering, or accompanied by fever, swelling, or difficulty breathing. Stop the medication and seek immediate medical attention.
- Signs of an allergic reaction: swelling of the face, eyes, lips, tongue, or throat; difficulty swallowing or breathing.
- New or worsening mental health problems: severe anxiety, agitation, depression, hallucinations, delusions, thoughts of harming yourself.
- Cardiovascular symptoms: chest pain, palpitations, shortness of breath.
- Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, unusual tiredness.
- Unusual bruising or bleeding.
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 symptoms you experienced.
If you have a history of heart problems or heart valve issues.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health status.
Remember, do not start, stop, or modify the dosage 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 symptoms you experienced.
If you have a history of heart problems or heart valve issues.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health status.
Remember, do not start, stop, or modify the dosage 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. You should continue to be under the care of your doctor while taking this medication.
To ensure your safety, avoid driving and engaging in other activities that require alertness until you understand how this medication affects you. If you do not feel fully awake after taking the drug, you may need to avoid these activities as well. If you continue to feel sleepy after taking this medication, consult your doctor.
This medication has the potential for abuse and may lead to 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 medical attention immediately.
As directed by your doctor, regularly monitor your blood pressure and heart rate. It is recommended to 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, discuss the potential risks with your doctor.
Limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances 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, consult your doctor.
If you are 65 years 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 for further information.
When taking this medication, 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 other activities that require alertness until you understand how this medication affects you. If you do not feel fully awake after taking the drug, you may need to avoid these activities as well. If you continue to feel sleepy after taking this medication, consult your doctor.
This medication has the potential for abuse and may lead to 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 medical attention immediately.
As directed by your doctor, regularly monitor your blood pressure and heart rate. It is recommended to 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, discuss the potential risks with your doctor.
Limit your consumption of caffeine (found in tea, coffee, cola) and chocolate, as combining these substances 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, consult your doctor.
If you are 65 years 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 for further information.
When taking this medication, 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:
- Agitation
- Insomnia
- Confusion
- Disorientation
- Hallucinations
- Tremor
- Tachycardia (fast heart rate)
- Hypertension (high blood pressure)
- Nausea
- Diarrhea
- Chest pain
What to Do:
Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Seek immediate medical attention. Treatment is generally supportive, focusing on managing symptoms.
Drug Interactions
Major Interactions
- Hormonal contraceptives (e.g., oral contraceptives, implants, IUDs) - decreased efficacy due to CYP3A4 induction.
- Cyclosporine - decreased cyclosporine levels due to CYP3A4 induction.
- Warfarin - increased INR due to CYP2C19 inhibition.
- Midazolam, Triazolam - decreased benzodiazepine levels due to CYP3A4 induction.
- Phenytoin - increased phenytoin levels due to CYP2C19 inhibition.
- Propranolol - increased propranolol levels due to CYP2C19 inhibition.
- Omeprazole - increased omeprazole levels due to CYP2C19 inhibition.
Moderate Interactions
- Tricyclic Antidepressants (e.g., clomipramine, desipramine) - potential for increased TCA levels.
- SSRIs (e.g., citalopram, escitalopram) - potential for altered SSRI levels.
- Antipsychotics (e.g., clozapine, quetiapine) - potential for decreased antipsychotic levels.
- CNS depressants (e.g., alcohol, sedatives) - additive CNS depressant effects.
- MAOIs - theoretical risk of hypertensive crisis (use with caution).
Confidence Interactions
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Armodafinil can cause increases in BP and HR. Baseline assessment is crucial.
Timing: Prior to initiation of therapy.
Psychiatric History (e.g., psychosis, mania, depression, suicidal ideation)
Rationale: Armodafinil can exacerbate or induce psychiatric symptoms.
Timing: Prior to initiation of therapy.
Sleep History and Diagnosis
Rationale: Confirm appropriate indication and rule out treatable underlying sleep disorders.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated).
Target: Maintain within patient's normal range or acceptable clinical limits.
Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.
Psychiatric Symptoms (e.g., anxiety, agitation, psychosis, mania, suicidal ideation)
Frequency: Regularly, especially during initial therapy and dose adjustments.
Target: Absence of new or worsening symptoms.
Action Threshold: Emergence or worsening of symptoms requires immediate evaluation and potential discontinuation.
Skin Rash/Hypersensitivity Reactions
Frequency: Regularly, especially during initial weeks of therapy.
Target: Absence of rash or signs of hypersensitivity.
Action Threshold: Any rash should prompt immediate discontinuation and medical evaluation.
Efficacy (reduction in excessive daytime sleepiness)
Frequency: Periodically, based on patient report and clinical assessment.
Target: Improved wakefulness and alertness.
Action Threshold: Lack of efficacy may warrant dose adjustment or alternative therapy.
Symptom Monitoring
- Chest pain
- Palpitations
- Shortness of breath
- Severe rash (e.g., blistering, peeling skin)
- Swelling of face, eyes, lips, tongue, or throat
- Difficulty swallowing or breathing
- Fever
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual bruising or bleeding
- New or worsening anxiety
- Agitation
- Depression
- Hallucinations
- Delusions
- Mania
- Suicidal thoughts or behavior
Special Patient Groups
Pregnancy
Armodafinil is Pregnancy Category C. 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. Animal studies have shown developmental toxicity at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of congenital anomalies based on animal data, though human data are limited and inconclusive.
Second Trimester:
Not well studied, but generally considered less critical for major organogenesis.
Third Trimester:
Not well studied. Potential for effects on fetal development or labor.
Lactation
Armodafinil and its metabolites are excreted in human milk. The effects on a breastfed infant are unknown. The American Academy of Pediatrics considers modafinil (racemic mixture) to be a drug for which the effect on nursing infants is unknown but may be of concern. Caution should be exercised when armodafinil is administered to a nursing woman.
Infant Risk:
L3 (Moderately Safe) - Limited human data; potential for non-serious adverse effects in infant. Monitor infant for irritability, poor feeding, sleep disturbances.
Pediatric Use
Safety and effectiveness in pediatric patients (under 17 years of age) have not been established. Use is not recommended due to concerns about serious adverse events, including rash (e.g., Stevens-Johnson Syndrome), and psychiatric adverse events.
Geriatric Use
Consider a lower starting dose (e.g., 75 mg once daily) in elderly patients due to potential for decreased clearance and increased sensitivity to adverse effects. Monitor closely for cardiovascular and psychiatric adverse events.
Clinical Information
Clinical Pearls
- Armodafinil is the R-enantiomer of modafinil, offering a longer half-life and potentially more sustained wakefulness compared to modafinil.
- Not indicated for mild-to-moderate fatigue or as a substitute for adequate sleep. It should be used as an adjunct to other management strategies (e.g., CPAP for OSA, sleep hygiene).
- Patients should be advised to discontinue armodafinil at the first sign of rash and seek medical attention immediately due to the risk of serious dermatologic reactions (e.g., SJS, TEN, DRESS).
- Monitor for psychiatric symptoms (anxiety, agitation, psychosis, mania, suicidal ideation), especially in patients with a history of psychiatric disorders.
- Patients should be counseled on the potential for decreased efficacy of hormonal contraceptives and advised to use alternative or concomitant birth control methods.
Alternative Therapies
- Modafinil (Provigil)
- Solriamfetol (Sunosi)
- Pitolisant (Wakix)
- Methylphenidate (various brands)
- Amphetamines (various brands)
- Sodium oxybate (Xyrem, Xywav) - for narcolepsy with cataplexy
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization)
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 is a valuable patient fact sheet. 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, we encourage you to discuss them with 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. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.