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Modafinil (brand name Provigil) is a wakefulness‑promoting agent that is used in certain sleep disorders (like narcolepsy) and sometimes off‑label for cognitive enhancement, fatigue, or other indications.
It is classified under U.S. federal law as a Schedule IV controlled substance, reflecting a lower but not negligible potential for misuse, dependence, or diversion.
Modafinil is a racemic mixture (R‑ and S‑enantiomers). Its precise mechanism of action is not fully understood; it appears to involve multiple neurochemical systems — including inhibition of dopamine reuptake, effects on norepinephrine, histamine, GABA, glutamate, orexin, among others.
Pharmacokinetically, modafinil is well absorbed with peak plasma concentrations usually 2–4 hours after ingestion; its elimination half‑life is about 12–15 hours in healthy adults. Major metabolism occurs by the liver (CYP enzymes), and 80% or so of dose is excreted in urine as metabolites.
Its therapeutic effects last many hours, making it useful for managing daytime sleepiness in chronic conditions.
Modafinil is officially approved in the United States under the brand name Provigil for three principal conditions:
These are the labelled (“on‑label”) uses in the U.S., and prescribing for other indications (e.g. ADHD, depression, cognitive enhancement) is considered off-label. Some clinicians and users pursue off‑label use, but evidence is more limited and the risk/benefit balance must be considered carefully.
Because modafinil does not treat the underlying disorder (e.g. it doesn’t fix airway obstruction in OSA), it should always be used in conjunction with the main therapy (e.g. CPAP in sleep apnea) rather than as a substitute.
Below is a detailed summary of the U.S. prescribing information (label) for Provigil (modafinil), based primarily on FDA labeling documents.
Important caveat: The full prescribing information is long and contains legal/clinical detail; this is a summary — always refer to the official label or your clinician for authoritative guidance.
Drug Identity & Formulations
As above: narcolepsy, OSAHS (as adjunct), and SWD.
Limitations of use:
The prescribing information contains many important warnings and precautions; key ones include:
From the labeling and clinical experience, common side effects (≥5%) include:
Less common or serious adverse events include the rash/hypersensitivity noted above, psychiatric symptoms, cardiovascular events, etc.
Modafinil has several potential drug interactions:
Some key points from the Patient Information / Medication Guide include:
Because of its wakefulness-promoting and purported attention-enhancing effects, modafinil has attracted interest for off-label use in healthy individuals (students, professionals, etc.). Some surveys indicate significant off‑prescription use.
However, off-label use carries additional risks: less clinical evidence, potential side effects, legal issues, lack of medical oversight, and the possibility of counterfeit or unsafe products if obtained illicitly. Regulatory and medical authorities caution against nonmedical use.
Additionally, cognitive benefits may be modest or variable — and long-term safety in healthy populations is not well established.
Because modafinil is a prescription medication, buying it online is fraught with risk. Many websites claim to sell modafinil without prescription, often at steep discounts. But many of those are illicit, unlicensed, or counterfeit. Regulatory agencies warn strongly about the dangers.
Here are safer approaches, caveats, and considerations.
The FDA has published consumer guidance on how to spot unsafe online pharmacies — red flags include no prescription requirement, extremely low prices, no staff pharmacist, lack of licensure, broken packaging, etc.
If you are legally permitted to use modafinil (i.e. have a valid prescription), here are safer routes:
Use only pharmacies that are licensed in the U.S. (or your jurisdiction) and require a prescription. The FDA's BeSafeRx program is a resource.
Some well-known chain pharmacies offer online ordering of your prescription medications (e.g. CVS, Walgreens, etc.).
If your physician can send the prescription directly to a reputable mail-order pharmacy, that is safer than random internet sellers.
In some places, you may consult with a licensed telehealth provider, get a legitimate prescription, and have it filled via integrated networks.
Some jurisdictions permit limited importation (e.g. up to 50 dosage units in the U.S.) if accompanied by a valid prescription and proper declaration at customs. However, this is legally and logistically complex and risky.
In some cases, people use overseas pharmacies in regulated jurisdictions. But risk is higher, and verifying legitimacy is critical (licensing, credentials, reputation, physical address).
In short: do not trust random vendors that promise modafinil without prescription. If you legitimately need modafinil, aim to use credentialed, regulated channels even if they cost more or are slower.
Below is a curated list of common questions and answers about modafinil / Provigil:
Provigil is the brand name version of modafinil. Generic modafinil contains the same active compound and, if manufactured properly, should be bioequivalent. Many users choose generic for cost reasons.
Modafinil is classified as a Schedule IV controlled substance, indicating a lower potential for abuse or dependence relative to stronger stimulants.
However, psychological dependence is possible, especially in off-label or nonmedical use. Some users report craving or habitual use. Clinical experience and surveillance suggest its abuse potential is relatively low but not zero.
Typically 12 to 15 hours, though individual responses vary (some shorter, some longer) based on metabolism, liver function, and other factors.
Higher doses have been used (up to 400 mg), but increased risk of side effects without proven additional benefit. There is limited safety data at high doses. Overdose can exacerbate side effects such as insomnia, tachycardia, hypertension, agitation, and in severe cases, possibly seizures. Always stick to prescribed dosing and seek emergency help if overdose is suspected.
The approved regimen is once daily, usually in the morning (or ~1 hour before a night shift for SWSD). Some clinicians may use divided doses off-label in narcolepsy (e.g. morning + noon) but that is not the standard label regimen.
Splitting or fragmenting tablets is not typically recommended unless explicitly supported by prescribing information or a compounding pharmacist, because uniform distribution of active drug may be compromised.
Do not double-up the next time. Usually you should skip the missed dose and resume your regular schedule, unless your provider advises differently. Always check with your prescribing physician or pharmacist for guidance.
Modafinil is not strongly associated with physical withdrawal like some stimulants, but some users may notice fatigue, sleepiness, or “rebound” sleepiness when discontinuing, especially after prolonged use. Gradual tapering may help in some cases, though not always required. Monitor closely.
Some off-label use exists. For ADHD, results are mixed; some studies show minor improvement in attention, but it is not FDA-approved for ADHD.
Some clinicians have used it adjunctively in depression or bipolar depression, but evidence is limited.
Interest in “nootropic” or cognitive enhancement use is widespread, but again, long-term safety and efficacy among healthy individuals is less established.
Yes. The safety in pregnancy is not well established (Category C historically). Animal studies suggest possible fetal harm; use only if benefits outweigh risks.
It is unknown whether modafinil passes into breast milk; caution is advised.
Alcohol use may exacerbate side effects such as liver stress, fatigue, or sleep disruption — and is generally discouraged. Combining modafinil with other stimulants can increase risk of side effects (e.g. elevated blood pressure, cardiovascular strain, insomnia). Always inform your healthcare provider of all substances you use.
Modafinil tends to produce milder stimulant effects, less jitteriness, and typically less cardiovascular stimulation compared to amphetamines. It is more selective for wakefulness rather than a general “high energy surge.” Its risk profile is considered more favorable for long-term use in approved populations.
However, individual responses vary.
Yes — modafinil can reduce the effectiveness of hormonal contraceptives (like ethinyl estradiol) due to enzyme induction. Use additional or alternative contraceptive methods during therapy and for one month after stopping.
Stop taking the medication immediately and seek medical evaluation, especially if rash is accompanied by swelling, blisters, mucosal involvement, fever, or systemic symptoms. Early discontinuation is crucial for preventing severe cutaneous reactions.
That depends on national regulatory laws. In the U.S., it is legal with prescription and regulated as a controlled substance. Importation without proper authorization is illegal. When traveling internationally, always check local laws; carry a valid prescription, the original packaging, and potentially a medical note. Some countries prohibit importation of controlled drugs even for personal use.
Store at controlled room temperature, away from moisture, heat, and light. Keep out of reach of children and secure to prevent misuse.
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