Armodafinil 50mg 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 stimulant; Dopamine reuptake inhibitor
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 daytime sleepiness caused by certain sleep disorders, such as narcolepsy, obstructive sleep apnea, or shift work sleep disorder. It helps you stay awake and alert, but it is not a substitute for getting enough sleep.
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 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 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 conditions, 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, away from the bathroom. Keep it in a safe and secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to store your medication.
When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you've been instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any 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 return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most out of your medication, follow your doctor's instructions 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 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 conditions, 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, away from the bathroom. Keep it in a safe and secure location where children and pets cannot access it, and where others cannot easily get to it. Consider using a locked box or area to store your medication.
When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless you've been instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any 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 return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take armodafinil exactly as prescribed by your doctor. Do not take more or less than directed.
- For narcolepsy or sleep apnea, take it in the morning. For shift work sleep disorder, take it about 1 hour before your work shift.
- Do not take armodafinil if you are not going to be awake for several hours, as it may cause difficulty sleeping later.
- Armodafinil is not a substitute for getting adequate sleep. Continue to practice good sleep hygiene (e.g., consistent sleep schedule, comfortable sleep environment).
- Avoid alcohol while taking armodafinil.
- Inform your doctor about all medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, especially hormonal birth control, as armodafinil can make it less effective.
- This medication may cause dizziness or blurred vision. Do not drive or operate machinery until you know how it affects you.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For Narcolepsy or Obstructive Sleep Apnea (OSA): 150 mg or 250 mg once daily in the morning. For Shift Work Sleep Disorder (SWSD): 150 mg once daily approximately 1 hour prior to the start of the work shift. 50mg tablets may be used for titration or specific patient needs, but are not the standard starting dose for these indications.
Dose Range:
50 - 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 Sleep Disorder (SWSD):
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
Moderate:
No specific dose adjustment recommended
Severe:
Use with caution; consider lower doses (e.g., 75 mg/day) and monitor for adverse effects.
Dialysis:
Not available; use with caution due to unknown dialyzability.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
Reduce dose by half (e.g., 75 mg/day) and monitor for adverse effects.
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 selectively binding to the dopamine transporter and inhibiting dopamine reuptake. Armodafinil also appears to affect other neurotransmitter systems, including histamine, norepinephrine, serotonin, and orexin, but its primary effects are believed to be mediated through dopaminergic pathways.
Pharmacokinetics
Absorption:
Bioavailability:
Not fully quantified, but well absorbed
Tmax:
Approximately 2 hours
FoodEffect:
Food delays Tmax by 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 readily available as a specific rate, but primarily hepatic metabolism and renal excretion of metabolites.
ExcretionRoute:
Urine (primarily as metabolites)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
2-4 hours
DurationOfAction:
Up to 12-15 hours
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of heart problems, including:
+ Chest pain
+ Fast, slow, or abnormal heartbeat
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Signs of depression or mood changes, including:
+ Suicidal thoughts
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ 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, such as difficulty starting or stopping urination, or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Muscle or joint pain
Diarrhea
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious skin reactions, which can affect body organs and be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness
Headache
Upset stomach
Trouble sleeping
Dry mouth
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 medical attention right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of heart problems, including:
+ Chest pain
+ Fast, slow, or abnormal heartbeat
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in vision
Signs of depression or mood changes, including:
+ Suicidal thoughts
+ Emotional ups and downs
+ Abnormal thinking
+ Anxiety
+ 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, such as difficulty starting or stopping urination, or changes in urine output
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Muscle or joint pain
Diarrhea
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious skin reactions, which can affect body organs and be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Dizziness
Headache
Upset stomach
Trouble sleeping
Dry mouth
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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:
- Skin rash, hives, blistering, or peeling skin (seek immediate medical attention)
- Swelling of the face, eyes, lips, tongue, or throat
- Difficulty swallowing or breathing
- Chest pain, palpitations, or fast/irregular heartbeat
- Shortness of breath
- Severe headache
- New or worsening anxiety, depression, agitation, aggression, or suicidal thoughts
- Hallucinations (seeing or hearing things that are not real)
- Delusions (false beliefs)
- Mania (unusual excitement, irritability, or uncontrolled thoughts)
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- 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 as a result of the allergy.
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 adjust 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 as a result of the allergy.
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 adjust 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 drug affects you. If you do not feel sufficiently awake after taking this medication, you may need to avoid these activities as well. If you continue to feel sleepy after taking this drug, 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, 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 problems, 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 severe rashes have occurred in this population. 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 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 drug affects you. If you do not feel sufficiently awake after taking this medication, you may need to avoid these activities as well. If you continue to feel sleepy after taking this drug, 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, 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 problems, 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 severe rashes have occurred in this population. 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 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
What to Do:
In case of overdose, seek immediate medical attention or call a poison control center. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- Hormonal Contraceptives (e.g., ethinyl estradiol, levonorgestrel): Armodafinil is a CYP3A4 inducer and can reduce the effectiveness of hormonal contraceptives. Patients should use alternative or concomitant methods of contraception.
- Warfarin: Armodafinil may alter warfarin metabolism (CYP2C19 inhibition, CYP3A4 induction). Monitor INR closely.
Moderate Interactions
- CYP3A4 Substrates (e.g., cyclosporine, midazolam, triazolam, simvastatin): Armodafinil can decrease plasma concentrations of these drugs.
- CYP2C19 Substrates (e.g., omeprazole, clopidogrel, phenytoin, diazepam, propranolol): Armodafinil can increase plasma concentrations of these drugs.
- Monoamine Oxidase Inhibitors (MAOIs): Use with caution; potential for increased pressor effects.
- Alcohol: Avoid concomitant use due to potential for impaired judgment and increased adverse effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Armodafinil can cause increases in BP and HR. Assess cardiovascular status.
Timing: Prior to initiation of therapy
Psychiatric History
Rationale: Assess for pre-existing psychiatric conditions (e.g., psychosis, mania, depression) as armodafinil can exacerbate these.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: Consider if hepatic impairment is suspected or for patients with known liver disease, as dose adjustments may be needed.
Timing: Prior to initiation of therapy (if indicated)
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly, especially during dose titration and periodically thereafter
Target: Maintain within normal limits or patient's baseline
Action Threshold: Significant or sustained increases warrant dose reduction or discontinuation.
Psychiatric Symptoms
Frequency: Regularly, especially during initial therapy and dose changes
Target: Absence of new or worsening symptoms (e.g., anxiety, depression, mania, psychosis, suicidal ideation)
Action Threshold: Emergence or worsening of psychiatric symptoms warrants immediate evaluation and potential discontinuation.
Skin Rash/Hypersensitivity Reactions
Frequency: Patient education for self-monitoring; clinical assessment at visits
Target: Absence of rash, hives, swelling, or other signs of hypersensitivity
Action Threshold: Any unexplained rash warrants immediate discontinuation and evaluation due to risk of severe dermatologic reactions (SJS/TEN).
Symptom Monitoring
- Chest pain
- Palpitations
- Shortness of breath
- Severe skin rash (e.g., blistering, peeling)
- Hives
- 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
- Depression
- Agitation
- Aggression
- Hallucinations
- Delusions
- Mania
- Suicidal thoughts or behavior
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. 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 monitor for adverse effects.
Third Trimester:
Human data limited; continue to monitor for adverse effects.
Lactation
It is unknown whether armodafinil or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed 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:
Unknown; potential for CNS effects in infant. Caution advised.
Pediatric Use
Safety and effectiveness in pediatric patients (under 17 years of age) have not been established. Use is not recommended in this population due to potential for serious adverse events, including serious rash.
Geriatric Use
Consider lower initial doses (e.g., 75 mg/day) 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.
- Patients should be advised that armodafinil is not a substitute for adequate sleep and should be used in conjunction with good sleep hygiene practices.
- Counsel patients on the risk of serious rash (e.g., Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) and to discontinue the drug at the first sign of rash.
- Warn female patients using hormonal contraceptives that armodafinil can reduce their effectiveness; advise use of alternative or concomitant contraception.
- Monitor blood pressure and heart rate regularly, especially in patients with pre-existing cardiovascular conditions.
- Assess for psychiatric symptoms (e.g., anxiety, depression, mania, psychosis, suicidal ideation) before and during treatment, as armodafinil can exacerbate or induce these.
Alternative Therapies
- Modafinil (Provigil)
- Methylphenidate (Ritalin, Concerta)
- Amphetamine/Dextroamphetamine (Adderall)
- Solriamfetol (Sunosi)
- Pitolisant (Wakix)
- Sodium Oxybate (Xyrem, Xywav)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (preferred or non-preferred brand/generic), may require prior authorization
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.