Armodafinil 250mg 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
Central nervous system stimulant, 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 stay awake and alert who have excessive sleepiness due to certain sleep disorders like narcolepsy, obstructive sleep apnea, or shift work sleep disorder. It is not a cure for these conditions and should be used along with other treatments, such as CPAP for sleep apnea or good sleep hygiene.
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 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 effects.
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 health issues, take it in the morning if you're taking it once a day. To avoid disrupting your sleep, try not to take 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 safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication. Remember to keep all medications away from 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, check with your pharmacist for guidance on the best disposal method. You may also want to look into 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 out of your medication, follow your doctor's instructions carefully. Read all the information provided to you 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 effects.
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 health issues, take it in the morning if you're taking it once a day. To avoid disrupting your sleep, try not to take 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 safe and secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication. Remember to keep all medications away from 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, check with your pharmacist for guidance on the best disposal method. You may also want to look into 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
- Take armodafinil exactly as prescribed, usually once a day in the morning for narcolepsy/OSA, or about an hour before your work shift for shift work sleep disorder.
- Do not take more than the prescribed dose, as it can be habit-forming.
- Avoid alcohol while taking this medication.
- Maintain good sleep hygiene (consistent sleep schedule, comfortable sleep environment, avoiding caffeine/heavy meals before bed).
- Armodafinil can decrease the effectiveness of hormonal birth control. Use an alternative or additional method of birth control while taking this medication 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 some drowsiness or dizziness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
150 mg or 250 mg once daily
Dose Range:
150 - 250 mg
Condition-Specific Dosing:
narcolepsy:
150 mg or 250 mg once daily in the morning.
obstructiveSleepApnea:
150 mg or 250 mg once daily in the morning. Doses up to 250 mg have been tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg dose.
shiftWorkSleepDisorder:
150 mg once daily 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 dose adjustment recommended, but caution advised.
Moderate:
No specific dose adjustment recommended, but caution advised.
Severe:
No specific dose adjustment recommended, but caution advised. Consider lower doses and monitor for adverse effects.
Dialysis:
Not available. Armodafinil is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Reduce dose by half (e.g., 75 mg or 125 mg once daily) in patients with severe hepatic impairment (Child-Pugh Class C).
Confidence:
Medium
Pharmacology
Mechanism of Action
The precise mechanism of action of armodafinil is unknown. It is thought to exert its wakefulness-promoting effects by increasing dopaminergic and noradrenergic signaling in the brain. It is an indirect dopamine receptor agonist and also affects histamine and orexin systems. Armodafinil is the R-enantiomer of modafinil.
Pharmacokinetics
Absorption:
Bioavailability:
High (well-absorbed)
Tmax:
Approximately 2 hours
FoodEffect:
Food may delay Tmax by approximately 2-4 hours but does not significantly affect the overall extent of absorption (AUC).
Distribution:
Vd:
Approximately 42 L
ProteinBinding:
Approximately 60% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 10-15 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (urine), mainly as metabolites
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour
PeakEffect:
Approximately 2 hours
DurationOfAction:
Approximately 12-15 hours
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, 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, or confusion.
Dark urine, yellow skin or eyes, or changes in urination (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 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. 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
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, or confusion.
Dark urine, yellow skin or eyes, or changes in urination (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 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. 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
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 new or worsening rash, blistering, or peeling skin (stop medication and seek immediate medical attention).
- Swelling of the face, eyes, lips, tongue, or throat; difficulty swallowing or breathing (signs of a severe allergic reaction, seek immediate medical attention).
- Fever, swollen glands, or other signs of infection (may indicate a serious drug reaction).
- Chest pain, shortness of breath, or fast/pounding heartbeat.
- New or worsening mental/mood changes (e.g., anxiety, depression, agitation, aggression, hallucinations, suicidal thoughts).
- Unusual thoughts or behavior.
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 initiate, discontinue, 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 initiate, discontinue, 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. Continue to follow your doctor's care and guidance.
To ensure your safety, avoid operating a vehicle or 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. If you continue to feel sleepy after taking this medication, consult your doctor.
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 discontinuing this medication, consult your doctor. Seek immediate medical attention if you experience a seizure or other severe side effects.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Avoid consuming alcohol while taking this medication. Before using marijuana, 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 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 it has been associated with severe rashes. Consult your doctor if you have any concerns.
When taking this medication, birth control pills and other hormone-based birth control methods may be less effective. 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 operating a vehicle or 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. If you continue to feel sleepy after taking this medication, consult your doctor.
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 discontinuing this medication, consult your doctor. Seek immediate medical attention if you experience a seizure or other severe side effects.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Avoid consuming alcohol while taking this medication. Before using marijuana, 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 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 it has been associated with severe rashes. Consult your doctor if you have any concerns.
When taking this medication, birth control pills and other hormone-based birth control methods may be less effective. 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
- Anxiety
- Excitement
- Hallucinations
- Mania
- Nausea
- Diarrhea
- Tachycardia (fast heart rate)
- Bradycardia (slow heart rate)
- Hypertension (high blood pressure)
- Chest pain
What to Do:
In case of overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including cardiovascular monitoring and management of agitation.
Drug Interactions
Contraindicated Interactions
- Known hypersensitivity to armodafinil or modafinil.
Major Interactions
- Hormonal contraceptives (e.g., oral contraceptives, implants, IUDs): Armodafinil can reduce the efficacy of hormonal contraceptives due to CYP3A4 induction. Patients should use alternative or concomitant methods of contraception.
- CYP3A4/5 substrates (e.g., cyclosporine, midazolam, triazolam, simvastatin): Armodafinil can decrease the plasma concentrations of these drugs.
- CYP2C19 substrates (e.g., phenytoin, diazepam, omeprazole, clopidogrel): Armodafinil can increase the plasma concentrations of these drugs due to CYP2C19 inhibition.
Moderate Interactions
- Warfarin: Increased INR and risk of bleeding due to CYP2C19 inhibition. Close monitoring of INR is required.
- Tricyclic antidepressants (e.g., clomipramine, imipramine): Potential for increased TCA levels due to CYP2C19 inhibition.
- Monoamine Oxidase Inhibitors (MAOIs): Use with caution; potential for additive pressor effects.
- Citalopram/Escitalopram: Potential for increased QT prolongation risk.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood pressure and heart rate
Rationale: Armodafinil can cause increases in blood pressure and heart rate.
Timing: Prior to initiation of therapy.
Psychiatric history (including mood disorders, psychosis, suicidal ideation)
Rationale: Armodafinil can exacerbate or induce psychiatric symptoms.
Timing: Prior to initiation of therapy.
ECG (if pre-existing cardiac conditions)
Rationale: To assess for underlying cardiac issues that could be exacerbated by stimulant effects.
Timing: Prior to initiation, especially in patients with known cardiovascular disease.
Routine Monitoring
Blood pressure and heart rate
Frequency: Regularly (e.g., monthly initially, then periodically)
Target: Within normal limits or patient's baseline
Action Threshold: Significant or sustained increases; consider dose reduction or discontinuation.
Psychiatric symptoms (e.g., mood changes, agitation, anxiety, psychosis, suicidal ideation)
Frequency: Regularly (e.g., at each follow-up visit)
Target: Absence of new or worsening symptoms
Action Threshold: Emergence or worsening of symptoms; consider dose reduction or discontinuation.
Skin reactions (e.g., rash, blistering)
Frequency: Patient education for self-monitoring
Target: Absence of rash
Action Threshold: Any new rash; discontinue immediately.
Symptom Monitoring
- Rash, blistering, or peeling skin
- Swelling of face, eyes, lips, tongue, or throat
- Difficulty swallowing or breathing
- Fever, swollen lymph nodes
- Chest pain, palpitations, shortness of breath
- New or worsening anxiety, depression, agitation, aggression
- Hallucinations, delusions, mania, suicidal thoughts
- Excessive sleepiness or rebound hypersomnia upon discontinuation
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 developmental toxicity based on animal data; human data limited.
Second Trimester:
Human data limited; continue to weigh risks vs. benefits.
Third Trimester:
Human data limited; continue to weigh risks vs. benefits.
Lactation
It is unknown whether armodafinil or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, 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:
Risk is unknown. Potential for CNS stimulation in the infant. Monitor for irritability, poor feeding, and sleep disturbances.
Pediatric Use
Safety and effectiveness in pediatric patients (under 17 years of age) have not been established. Use is not recommended.
Geriatric Use
Consider a lower initial dose (e.g., 75 mg) 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 symptoms.
Clinical Information
Clinical Pearls
- Armodafinil is the longer-acting R-enantiomer of modafinil, offering a more sustained wakefulness effect.
- Counsel patients on the importance of using reliable non-hormonal contraception due to potential interaction with hormonal birth control.
- Emphasize the importance of immediately reporting any rash or signs of hypersensitivity, as severe skin reactions (e.g., SJS, DRESS) can occur.
- Monitor for psychiatric symptoms, especially in patients with a history of mental illness, as armodafinil can exacerbate or induce mania, psychosis, or suicidal ideation.
- Advise patients that armodafinil is not a substitute for adequate sleep and should be used in conjunction with good sleep hygiene practices.
- Potential for abuse and dependence exists, although 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 - for narcolepsy with cataplexy)
Cost & Coverage
Average Cost:
$300 - $800 per 30 tablets (250mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 name of the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
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 name of the medication taken, the amount, and the time it occurred.