Modafinil 100 mg tablets contain 100 mg of modafinil, a wakefulness-promoting medicine available in the United States as a prescription medication. The U.S. brand PROVIGIL® (modafinil) is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).
The U.S. labeling lists 100 mg and 200 mg tablets as available dosage strengths. The 100 mg strength can therefore be relevant when a healthcare professional determines that an individualized dose or dose adjustment is appropriate.
Modafinil is classified as a Schedule IV controlled substance in the United States and is available by prescription only.
Key Facts About Modafinil 100 mg
| Information | Details |
|---|---|
| Active ingredient | Modafinil |
| Strength | 100 mg |
| Dosage form | Oral tablet |
| U.S. brand | PROVIGIL® |
| U.S. prescription status | Prescription only |
| DEA classification | Schedule IV (C-IV) |
| U.S. approval | 1998 |
| Main approved uses | Narcolepsy, OSA-associated excessive sleepiness, shift work disorder |
| Available tablet strengths | 100 mg and 200 mg |
These details are based on current U.S. prescribing information and DailyMed labeling.
What Is Modafinil 100 mg?
Modafinil is a prescription wakefulness-promoting medicine. In the United States, it is approved for improving wakefulness in adults experiencing excessive sleepiness associated with narcolepsy, obstructive sleep apnea, or shift work disorder.
Modafinil 100 mg refers specifically to a tablet containing 100 mg of the active ingredient. It should not be confused with armodafinil, which is a different medication.
Modafinil 100 mg Uses in the USA
U.S. prescribing information identifies three primary approved uses:
1. Narcolepsy
Modafinil is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy.
2. Obstructive Sleep Apnea
Modafinil is indicated for excessive sleepiness associated with OSA. It does not treat the underlying airway obstruction. Appropriate treatment of the obstruction, such as CPAP when indicated, remains important.
3. Shift Work Disorder
Modafinil is indicated to improve wakefulness in adults with excessive sleepiness associated with shift work disorder.
Modafinil 100 mg Dosage Information
The U.S. prescribing information lists a recommended dose of 200 mg once daily for narcolepsy or OSA and 200 mg once daily approximately one hour before the start of a work shift for shift work disorder.
Therefore, 100 mg should not automatically be described as the standard U.S. adult dose. The 100 mg tablet is an approved dosage strength and may be used when a healthcare professional determines an appropriate individualized regimen.
Patients with severe hepatic impairment may require a reduced dose, while lower doses may also be considered for some geriatric patients.
Modafinil 100 mg Tablets Available in the USA
U.S. labeling identifies both 100 mg and 200 mg modafinil tablets. Current DailyMed listings include PROVIGIL 100 mg tablets and identify the medicine as Rx only and C-IV.
When searching for this medicine in the United States, users may encounter terms such as:
Modafinil 100 mg tablets
Modafinil 100 mg USA
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PROVIGIL 100 mg
Generic modafinil 100 mg
Modafinil prescription tablets
Modafinil wakefulness medicine
Modafinil for narcolepsy
Modafinil for shift work disorder
Modafinil for excessive daytime sleepiness
Important Safety Information
Modafinil should be used under the supervision of a qualified healthcare professional.
The U.S. label contains important warnings concerning serious skin reactions, including Stevens-Johnson syndrome, as well as angioedema, anaphylaxis, and multi-organ hypersensitivity reactions. Patients should seek medical attention for concerning symptoms and follow their prescriber's instructions.
The label also identifies possible psychiatric symptoms and recommends caution in patients with certain psychiatric histories. Cardiovascular monitoring may also be appropriate for patients with known cardiovascular disease.
Is Modafinil a Controlled Substance in the USA?
Yes. Modafinil is a Schedule IV controlled substance in the United States.
Because of its controlled-substance status, prescriptions, dispensing, possession, and distribution are subject to applicable U.S. federal and state laws.
Modafinil should not be promoted or supplied as a general-purpose cognitive enhancer or recreational product. FDA information identifies modafinil as a prescription medicine used for specific sleep-related medical conditions.
Modafinil 100 mg vs. 200 mg
| Feature | Modafinil 100 mg | Modafinil 200 mg |
|---|---|---|
| Active ingredient | Modafinil | Modafinil |
| Strength | 100 mg | 200 mg |
| Tablet form | Oral | Oral |
| U.S. availability | Yes | Yes |
| Prescription medicine | Yes | Yes |
| Schedule | C-IV | C-IV |
| Standard labeled adult dose | Not generally the standard recommended dose | 200 mg once daily is the labeled recommendation for the main indications |
The appropriate strength and regimen should be determined by a healthcare professional.
Frequently Asked Questions (FAQ)
1. What is Modafinil 100 mg?
Modafinil 100 mg is an oral tablet containing 100 mg of the active ingredient modafinil. It is an available U.S. tablet strength of the prescription medicine used to improve wakefulness in certain sleep-related disorders.
2. What is Modafinil used for in the USA?
U.S. labeling indicates modafinil for improving wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, or shift work disorder.
3. Is Modafinil 100 mg FDA approved?
Modafinil is FDA approved in the United States, and U.S. labeling identifies 100 mg and 200 mg tablet strengths. The original U.S. approval of PROVIGIL was in 1998.
4. Is 100 mg the standard dose of Modafinil?
No. The current U.S. prescribing information recommends 200 mg once daily for narcolepsy and OSA and 200 mg once daily approximately one hour before a work shift for SWD. A healthcare professional should determine the appropriate dose for an individual patient.
5. Is Modafinil 100 mg available in the USA?
Yes. U.S. DailyMed labeling lists modafinil 100 mg tablets, including PROVIGIL 100 mg tablets.
6. Is Modafinil a prescription drug?
Yes. Modafinil is a prescription-only medicine in the United States.
7. Is Modafinil a controlled substance?
Yes. Modafinil is classified as a Schedule IV controlled substance in the United States.
8. What is the difference between Modafinil and Armodafinil?
They are different medicines. Modafinil contains modafinil, while armodafinil contains the R-enantiomer of modafinil. They have different prescribing information and should not be treated as identical products.
9. Can Modafinil be used for general focus or studying?
Using prescription modafinil solely for studying, productivity, or general cognitive enhancement is not one of the FDA-approved indications listed in the U.S. prescribing information. It should be used only as directed by a qualified healthcare professional.
10. Where can I find official information about Modafinil in the USA?
The FDA and DailyMed provide official U.S. drug and prescribing information. Current DailyMed labeling identifies PROVIGIL as a prescription, Schedule IV medicine containing modafinil.
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For prescription and controlled medicines such as modafinil, availability, dispensing, importation, and possession are subject to applicable laws and regulations in the destination country. Customers should consult a licensed healthcare professional and verify applicable regulatory requirements before obtaining or using prescription medicines.
Disclaimer
This article is provided for general pharmaceutical and educational information only and does not constitute medical advice. Modafinil is a prescription Schedule IV controlled substance in the United States. Do not start, stop, or change treatment without consulting a qualified healthcare professional. Always refer to the latest FDA-approved prescribing information.
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