Modvigil 200 mg (Modafinil) by HAB Pharma: Uses, Prescription Status & Safety
Updated: Aug 21
Written by Dr. Adam Makis in TheSkyMeds Editorial Standards
Medically reviewed by Jonathan Reed, Medical Content Reviewer Aug 19 2026
Introduction
Modvigil 200 mg is a tablet containing modafinil 200 mg and is listed by its manufacturer, HAB Pharmaceuticals & Research Ltd., as a central nervous system product. Modafinil is a wakefulness-promoting prescription medicine used in the United States for excessive sleepiness associated with certain diagnosed sleep disorders.
The important distinction is that Modvigil is a brand containing modafinil, while U.S. FDA labeling applies to FDA-approved modafinil products—not automatically to every international modafinil brand.
This guide explains what Modvigil 200 mg contains, who manufactures it, what modafinil is medically used for, U.S. prescription and controlled-substance status, dosing information, side effects, interactions, and major safety warnings.
Medical note: This article is for educational purposes. Modafinil should be used only after appropriate medical evaluation and according to a prescription where required.
Modvigil 200 mg at a Glance
Feature | Information |
Brand | Modvigil 200 |
Active ingredient | Modafinil |
Strength | 200 mg |
Manufacturer | HAB Pharmaceuticals & Research Ltd. |
Product category | Central nervous system |
Manufacturer-listed packing | 10 × 10 tablets |
U.S. modafinil status | Prescription medicine |
U.S. controlled-substance status | Schedule IV |
FDA-labeled modafinil uses | Narcolepsy, OSA-related excessive sleepiness, shift work disorder |
HAB Pharma's official Modvigil 200 product listing identifies the tablet as containing modafinil 200 mg.
What Is Modvigil 200 mg?
Modvigil 200 is a brand-name tablet containing 200 mg of modafinil.
Modafinil is described in U.S. prescribing information as a wakefulness-promoting agent. It is different from traditional amphetamine medications, although it affects brain systems involved in wakefulness and alertness.
The exact mechanism by which modafinil promotes wakefulness is not completely understood. U.S. labeling notes that modafinil has wake-promoting effects and interacts with dopamine transport pathways, but its pharmacologic profile is not identical to classic sympathomimetic stimulants.
For broader information about medicines affecting the brain and nervous system, see our guide to Neuro and CNS Care.
Who Manufactures Modvigil 200?
Modvigil 200 is listed by HAB Pharmaceuticals & Research Ltd.
The manufacturer's official product page lists:
Product: Modvigil 200 Tab
Composition: Modafinil 200 mg
Packing: 10 × 10 tablets
Category: Central Nervous System
HAB Pharmaceuticals & Research Ltd. describes itself as an Indian pharmaceutical manufacturer with manufacturing operations in India.
Readers researching a medicine by brand name should always distinguish between:
The brand name
The active pharmaceutical ingredient
The manufacturer
Regulatory approval in the country where the medicine will be used
See the official HAB Pharmaceuticals Modvigil listing and HAB Pharmaceuticals manufacturing information.
What Is Modafinil Used For?
In the United States, FDA-approved modafinil labeling covers excessive sleepiness associated with three conditions.
Narcolepsy
Narcolepsy is a neurological sleep disorder that can cause excessive daytime sleepiness and sudden difficulty remaining awake.
Modafinil is used to improve wakefulness in adults with excessive sleepiness associated with narcolepsy.
It does not cure narcolepsy.
Obstructive Sleep Apnea
Modafinil can be prescribed for excessive sleepiness associated with obstructive sleep apnea (OSA).
However, this is an important limitation:
Modafinil does not treat the airway obstruction causing sleep apnea.
If continuous positive airway pressure (CPAP) or another treatment has been prescribed for OSA, modafinil is not a replacement for that therapy. U.S. labeling specifically states that appropriate treatment of the underlying obstruction should continue.
Shift Work Disorder
Modafinil is also indicated for excessive sleepiness associated with shift work disorder, a circadian sleep disorder affecting people whose work schedules conflict with normal sleep hours.
The current DailyMed modafinil prescribing information covers all three U.S. indications.
Is Modvigil 200 FDA-Approved in the United States?
This question needs careful wording.
Modafinil is an FDA-approved active ingredient in the United States for specified sleep-related indications.
However, FDA approval of modafinil products should not automatically be interpreted as FDA approval of every modafinil brand sold internationally.
For this article, the U.S. regulatory and safety information comes from FDA-associated/DailyMed labeling for approved modafinil products.
Therefore, it is more accurate to say:
Modvigil 200 contains modafinil 200 mg, while U.S. FDA-approved modafinil labeling applies to products specifically approved for the U.S. market.
The article should not claim “Modvigil is FDA-approved” unless that specific brand and product can be verified in FDA regulatory records.
Is Modvigil 200 a Prescription Medicine?
In the United States, modafinil is a prescription medicine and a Schedule IV controlled substance.
Schedule IV status means its prescribing and dispensing are subject to federal controlled-substance rules.
U.S. prescribing information also recognizes that modafinil can produce psychoactive effects and has potential for misuse or abuse. Patients with a history of drug or stimulant misuse may require closer monitoring.
The DailyMed Medication Guide for modafinil specifically identifies it as a C-IV prescription medicine.
Prescription and controlled-drug rules can differ between countries, so readers should follow the law and prescribing requirements where they live.
Is Modvigil the Same as Provigil?
Modvigil and Provigil contain the same active drug—modafinil—but they are not the same branded product.
Provigil is a U.S. brand of modafinil.
Modvigil is listed by HAB Pharmaceuticals as a product containing modafinil 200 mg.
It would be inaccurate to automatically describe Modvigil as an FDA-approved generic equivalent of Provigil without product-specific regulatory equivalence data.
When comparing medicines, look beyond the active ingredient and consider:
Manufacturer
Regulatory approval
Tablet formulation
Strength
Quality and supply chain
Country-specific prescribing status
How Is Modafinil 200 mg Usually Prescribed?
The following information describes U.S. modafinil labeling and is not a personal dosing recommendation.
Narcolepsy
The recommended U.S. dose is:
200 mg once daily in the morning.
Obstructive Sleep Apnea
The recommended dose for excessive sleepiness associated with OSA is also:
200 mg once daily in the morning.
Again, modafinil does not replace treatment of the underlying airway obstruction.
Shift Work Disorder
For shift work disorder, U.S. labeling recommends:
200 mg approximately one hour before the start of the work shift.
The prescribing information notes that doses up to 400 mg/day have been tolerated in clinical studies, but there is no consistent evidence of additional benefit over 200 mg/day for narcolepsy or OSA.
People should not increase their dose to improve concentration or stay awake longer without medical direction.
Can Modafinil Be Taken With Food?
U.S. patient information states that modafinil may be taken with or without food.
Timing may be more important because taking a wakefulness-promoting medicine too close to bedtime may interfere with sleep.
Patients should follow the dosing schedule provided for their diagnosed condition.
What Are the Benefits of Modafinil?
The established medical benefit of modafinil is improved wakefulness in adults with excessive sleepiness associated with approved sleep disorders.
This should be separated from internet claims about:
Productivity enhancement
Studying
Memory enhancement
General fatigue
“Brain boosting”
Working for unusually long periods
Recreational nootropic use
Those claims do not represent the FDA-approved indications discussed in current U.S. labeling.
Is Modvigil a “Smart Pill” or Nootropic?
Modafinil is frequently discussed online as a “smart drug” or nootropic, but that is different from its approved medical use.
Its established U.S. indications involve excessive sleepiness associated with diagnosed sleep disorders—not routine cognitive enhancement in healthy people.
A person who feels chronically tired or unable to concentrate may have an underlying issue such as:
Inadequate sleep
Sleep apnea
Medication effects
Depression or anxiety
Thyroid disease
Anemia
Another sleep or medical disorder
Using a wakefulness-promoting drug without evaluating the underlying cause can mask an important health problem.
For more background, read What Are Smart Pills? Benefits, Uses & Risks Explained and Smart Pills vs Nootropics: What's the Difference?.
Common Side Effects of Modafinil
In pooled placebo-controlled trials, common adverse reactions reported more often with modafinil included:
Headache
Nausea
Nervousness
Rhinitis
Diarrhea
Back pain
Anxiety
Insomnia
Dizziness
Indigestion
Headache was particularly common in clinical trials.
Side effects can vary from person to person, and the absence of early side effects does not guarantee that serious reactions cannot occur later.
Serious Skin Reactions: An Important Warning
One of the most important modafinil safety warnings involves serious skin reactions.
Rare but potentially serious or life-threatening reactions reported with modafinil include:
Stevens-Johnson syndrome (SJS)
Toxic epidermal necrolysis (TEN)
DRESS
Multi-organ hypersensitivity reactions
U.S. labeling explains that it is not possible to reliably predict which rashes will become serious.
A new rash while taking modafinil should therefore be taken seriously and medically assessed promptly.
Emergency symptoms can include rash together with:
Blistering or peeling skin
Mouth sores
Swelling of the face or throat
Difficulty breathing or swallowing
Fever
Signs of organ involvement
Psychiatric Side Effects
Modafinil can also affect mood and mental health.
Reported psychiatric reactions include:
Anxiety
Nervousness
Insomnia
Agitation
Depression
Confusion
Postmarketing reports have also included more serious effects such as:
Mania
Hallucinations
Delusions
Aggression
Suicidal thoughts
Extra caution is appropriate in people with a history of psychosis, depression, mania, or other significant psychiatric illness.
Heart Rate and Blood Pressure
Modafinil may require additional monitoring in people with cardiovascular disease or high blood pressure.
Clinical-trial data did not show large average blood-pressure changes overall, but a greater proportion of modafinil-treated patients required new or increased antihypertensive medication compared with placebo.
The label recommends considering increased monitoring of blood pressure and heart rate, particularly in patients with cardiovascular concerns.
Tell a clinician if you have:
High blood pressure
Heart disease
Previous heart attack
Chest pain
Palpitations
Other cardiovascular conditions
Modafinil Drug Interactions
Modafinil can affect enzymes involved in the metabolism of other medicines.
Important examples include:
Hormonal Contraceptives
Modafinil can reduce the effectiveness of steroidal hormonal contraceptives.
Current U.S. labeling recommends alternative or additional contraception during modafinil treatment and for one month after stopping it.
This is one of the most clinically important interactions to discuss before treatment.
Cyclosporine
Modafinil may reduce blood concentrations of cyclosporine, potentially requiring monitoring and dosage adjustment.
CYP2C19 Substrates
Modafinil can increase exposure to certain medicines metabolized through CYP2C19, including examples such as:
Diazepam
Phenytoin
Omeprazole
Propranolol
Warfarin
More frequent monitoring of prothrombin time/INR may be appropriate when modafinil is used with warfarin.
MAO Inhibitors
The label recommends caution when modafinil is administered with monoamine oxidase inhibitors.
Always give the prescriber or pharmacist a complete list of prescription medicines, OTC products, supplements, and herbal products.
Modafinil and Alcohol
The U.S. Medication Guide advises patients to avoid alcohol because it is not known how alcohol will affect them while taking modafinil.
Combining substances that affect alertness, judgment, sleep, or cardiovascular function should not be treated casually.
Pregnancy and Modafinil
Pregnancy requires special caution.
Current U.S. labeling includes concern about potential fetal harm based on animal data and reported pregnancy outcomes.
Anyone who is pregnant, trying to become pregnant, or could become pregnant should discuss modafinil with a healthcare professional before use.
This is particularly important because modafinil can also reduce hormonal contraceptive effectiveness.
Is Modafinil Approved for Children?
No. U.S. modafinil labeling does not approve it for pediatric patients for any indication.
Serious skin reactions were among the concerns identified during pediatric development programs.
Parents should not give modafinil to children based on adult dosing information found online.
Modafinil in Older Adults and Liver Disease
The dose may require modification in some populations.
Severe Liver Impairment
U.S. labeling recommends reducing the modafinil dose to one-half of the usual recommended dose in patients with severe hepatic impairment.
Older Adults
Lower doses and closer monitoring may be considered in older adults because elimination of modafinil may be reduced with aging.
Can Modafinil Cause Dependence or Be Abused?
Modafinil is a Schedule IV controlled substance in the United States.
Its abuse potential is lower than many Schedule II stimulants, but lower does not mean zero.
Clinical and experimental data show that modafinil can produce psychoactive and euphoric effects and can be reinforcing.
People with a history of stimulant or substance misuse may need closer monitoring for:
Dose escalation
Drug-seeking behavior
Use outside the prescription
Combining the medicine with other stimulants
Modafinil should not be shared with another person.
What Happens if Too Much Modafinil Is Taken?
Taking more than prescribed can cause significant adverse effects.
Reported overdose symptoms include:
Severe insomnia
Restlessness
Agitation
Anxiety
Confusion
Disorientation
Hallucinations
Nausea
Diarrhea
Fast or slow heart rate
High blood pressure
Chest pain
Suspected overdose requires urgent medical assessment.
How Should Modvigil 200 Be Stored?
Storage instructions should come from the specific product packaging and manufacturer.
General medicine-storage principles include:
Keep tablets in their labeled packaging
Protect them from inappropriate heat and moisture
Store securely away from children
Check the expiration date
Avoid using damaged or unidentified tablets
For general medication safety, see Why You Should Always Check Medicine Expiry Dates.
How to Evaluate a Modvigil 200 Product
Because Modvigil searches often involve manufacturer and product-authenticity questions, verify basic product details rather than relying only on a seller description.
Check:
Product name
Active ingredient
Strength
Manufacturer
Batch/lot information
Expiration date
Packaging integrity
Country-specific regulatory status
Prescription requirements
Source of the medicine
HAB Pharmaceuticals' own product listing is the strongest source for confirming that Modvigil 200 is listed as a modafinil 200 mg product manufactured under the HAB brand.
Conclusion
Modvigil 200 mg is a modafinil 200 mg product listed by HAB Pharmaceuticals & Research Ltd. The most important thing for readers to understand is the difference between the Modvigil brand and the broader medical and regulatory information available for modafinil.
In the United States, modafinil is a prescription Schedule IV medicine used to improve wakefulness in adults with certain diagnosed sleep disorders. It has meaningful benefits for appropriate patients, but it also carries important warnings involving serious skin reactions, psychiatric effects, cardiovascular monitoring, drug interactions, pregnancy, contraceptive effectiveness, and misuse.
For more background on medications used in brain and nervous-system care, read our Neuro & CNS Care Guide.
Use product and medical information to support an informed discussion with a qualified healthcare professional—not to replace diagnosis or prescribing.
Frequently Asked Questions
1. What is Modvigil 200 mg?
Modvigil 200 is a HAB Pharmaceuticals product containing modafinil 200 mg. The manufacturer lists it within its central nervous system product range.
2. Who manufactures Modvigil 200?
HAB Pharmaceuticals & Research Ltd. lists Modvigil 200 on its official product website.
3. What is the active ingredient in Modvigil?
The active ingredient is modafinil 200 mg.
4. What is modafinil used for?
U.S. modafinil labeling covers excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.
5. Is Modvigil 200 FDA-approved?
Do not assume that FDA approval of modafinil means every international modafinil brand is FDA-approved. U.S. regulatory claims should be verified for the specific product and manufacturer.
6. Is modafinil available without a prescription in the USA?
No. Modafinil is a prescription Schedule IV controlled substance in the United States.
7. Is 200 mg a normal modafinil dose?
200 mg is the recommended U.S. labeled dose for several adult indications, but that does not mean it is appropriate for every individual.
8. Can Modvigil be used for studying or productivity?
Cognitive enhancement in healthy people is not one of the FDA-approved modafinil indications discussed in U.S. labeling.
9. Does modafinil replace CPAP for sleep apnea?
No. Modafinil may treat residual excessive sleepiness in appropriate OSA patients, but it does not treat the underlying airway obstruction or replace prescribed CPAP therapy.
10. Can modafinil affect birth control?
Yes. Modafinil can reduce the effectiveness of steroidal hormonal contraceptives. U.S. labeling recommends alternative or additional contraception during treatment and for one month after stopping.
11. What should I do if I develop a rash while taking modafinil?
Contact a healthcare professional immediately. Serious and potentially life-threatening skin reactions have been reported, and it is not possible to reliably predict which rashes will become serious.
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