The Legality of Modafinil in the USA: Prescriptions, Imports, and Laws

Modafinil is a drug which produces a natural sense of vigilance, wakefulness and alertness. Its on label uses are to treat narcolepsy, shift-worker sleep disorder, and obstructive sleep apnea/hypopnea syndrome. In the USA, Modafinil is also sometimes used by individuals with ADHD or as an off-label “smart drug”.

Modafinil belongs to a family of drugs known as eugeroics, or wakefulness promoting agents. At first glance, Modafinil sounds like the holy grail of nootropics and many reviews state that it is one of the most effective cognitive enhancers available. Users report it increases motivation, relieves fatigue and improves overall mood.

Getting Modafinil in the USA is a matter of some legal controversy and individuals should be aware of the complexities of the law. What exactly is the legal status of Modafinil in the United States?

This article will provide background information on the history of Modafinil’s development, its mechanisms of action, its approved uses, popular off-label uses, and common side effects, as well as the legal status of Modafinil in the United States, and some legal non-prescription alternatives.

Modafinil

Ergogenic Drug

Alertness

Mental Acuity

Focus

How It Works:

• Stimulates wakefulness in the brain
• Promotes mental acuity & processing
• Enhances focus, motivation & energy

Dosage:

Between 100 - 200 mg per day

Safety:

Some Reported Side Effects

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Modafinil History

The discovery of Modafinil actually came about because of testing on another related compound.

During the late 1970s, a researcher named Michel Jouvet who worked for the French pharmaceutical company Lafon Laboratories was experimenting by making various adjustments to compounds looking to develop a new analgesic.

During his testing he came across a compound named Adrafinil which seemed to have an unusual effect. In animal testing, this compound was seen to cause increased locomotion and alertness.

Further research in humans showed it increased wakefulness and caused the user to become especially productive without the sensation of hyperactivity usually associated with stimulants.

Adrafinil is an inert substance, but when ingested, it is metabolized in the liver into its component parts. The primary active compound in Adrafinil is the substance we now call Modafinil.

This type of compound, which is metabolized by the body into an effective substance, is called a prodrug; therefore, Adrafinil is the prodrug of Modafinil. The conversion process takes about 25 minutes to an hour, after which the resultant effects are experienced.

Eventually, researchers at Lafon were able to develop Modafinil directly. Soon after that, Lafon ceased its production of Adrafinil because as it was no longer necessary.

Cephalon, the company that bought Lafon Laboratories in 2001, still makes the most popular brand name version of Modafinil available on the market today, called Provigil (also known as Alertec and Modavigil in some countries).

Modafinil’s Mechanisms of Action

The exact mechanism of action of Modafinil has still not been determined. Regardless, it has been seen to have effects on a variety of neurotransmitters and their neurons and transporters in the brain and central nervous system. Some of the neurotransmitters that have been seen to be effected by Modafinil in testing include Epinephrine (Adrenaline), Norepinephrine (Noradrenaline), Serotonin, Dopamine, Histamine, and Orexin (Hypocretin).

As mentioned, that exact mechanism of action is still unknown, but some of the leading theories of how Modafinil primarily causes effects in the body relate to its effects on Orexin and Histamine. Modafinil has been seen to strongly active Orexin neurons in the hypothalamus. Orexin is a neuropeptide that is involved in the regulation of various bodily processes including sleep and wake state, appetite, and arousal.

Orexin in turn stimulates the release of the neurotransmitter Histamine. In addition to physical effects such as mounting an allergic response, contracting smooth muscles, and dilating blood vessels, like Orexin, Histamine is involved with promoting wakefulness, arousal, and appetite.

The wakeful state provided by Modafinil has been found to differ compared to that of amphetamines in that it does not produce nervousness or agitation. Most users report sleeping shorter hours without feeling fatigued mentally or physically.

Because Adrafinil before it was seen to have wakefulness promoting effects, and was actually approved as a treatment for narcolepsy sleep disorder, the first human trials of Modafinil were for treating this disorder as well.

Modafinil for Sleep Disorders

Narcolepsy is a serious sleep disorder where people have issues with maintaining wakefulness. Even with a good quantity and quality of sleep the night before, narcoleptics can fall asleep randomly multiple times per day, and experience excessive daytime sleepiness.

Modafinil has been shown in a large number of double-blind placebo-controlled research studies to increase wakefulness and reduce excessive sleepiness in people with narcolepsy. When given Modafinil, scores on a variety of sleep tests including the Epworth Sleepiness Scale, the Maintenance of Wakefulness test, and the Multiple Sleep Latency test are significantly improved over baseline scores and placebo scores.

Modafinil was approved as a prescription drug to treat narcolepsy by the FDA in 1998. Since that time, it has been officially approved for two other sleep disorders as well, namely shift-work sleep disorder and obstructive sleep apnea/hypopnea syndrome.

When working overnight, very late night, or extended hour work shifts, some people can develop shift work sleep disorder (SWSD). These people must be awake during the night for work, and then sleep during the day. This switch of a normal circadian rhythm can cause excessive sleepiness when awake at night, and sometimes issues when trying to sleep during the day, such as insomnia.

One study gave patients with SWSD a dose of either a placebo or Modafinil an hour before they began a nighttime work shift, and then measured their performance using the Psychomotor Vigilance test. It was seen that the Modafinil patients had improved performance over the placebo patients, with fewer and shorter attention lapses during the night.

Another similar study tested patients’ functioning using the Functional Outcomes of Sleep Questionnaire, and their quality of life using the Short Form Health Survey. Modafinil was seen to significantly improve scores on both tests compared to placebo over a 12 week period

Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a potentially serious medical condition where breathing is obstructed or temporarily stops while sleeping. In this condition, the upper airway becomes obstructed by the tongue and/or soft palate. A partial blockage causes shallow, labored breathing, known as hyponea (from Greek, “low breathing”); a complete blockage causes the temporary stopping of breathing, known as apnea (“no breathing”).

There can be many of these breathing episodes each hour every night, which can lead to very poor sleep quality, and consequent excessive daytime sleepiness.

The most common treatment for OSAHS is using a continuous positive airway pressure (CPAP) machine while sleeping to keep the airway clear and prevent these breathing episodes. Even with this treatment, some people still experience residual excessive daytime sleepiness.

In studies, using Modafinil has been seen to improve excessive sleepiness in patients with OSAHS that are being treated with CPAP. Significantly greater changes have been seen from baseline on the Epworth Sleepiness Scale and multiple sleep latency times when using Modafinil versus a placebo.

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Off-Label Uses of Modafinil: ADHD

Modafinil has only been officially approved as a treatment in the United States for the sleep disorders discussed above: narcolepsy, SWSD, and OSAHS. It has been been similarly classified in many other countries around the world. It has also been approved as a treatment for another sleep disorder, hypersomnia, in some countries.

It is estimated however, that as much as 90% of all prescriptions written for Modafinil are actually for off-label uses, or any use that is not an approved use. Some of these off label uses relate to Modafinil’s approved uses and its wakefulness promoting effects. Modafinil is sometimes used to reduce fatigue associated with diseases such as Parkinson’s disease, depression, multiple sclerosis, fibromyalgia, and chronic fatigue syndrome.

One of the most common off-label uses of Modafinil relates to its stimulating effects. Modafinil has been studied extensively as an alternative treatment drug for attention-deficit disorder (ADD) and attention-deficit hyperactivity disorder (ADHD).

Many different double-blind placebo-controlled studies have found that compared to a placebo, Modafinil is significantly better at improving scores on a variety of ADHD tests including Conners Rating Scales, Teacher and Parent ADHD Rating Scale-IV, and the Clinical Global Impressions-Improvement scale.

In one study, researchers compared Modafinil to not only a placebo, but also to a traditional ADHD medication, dextroamphetamine (Dexedrine). It was seen that both active drugs significantly outperformed the placebo, and that Modafinil has a similar range of effects as dextroamphetamine. It was suggested therefore that Modafinil should be considered a viable alternative to conventional stimulant ADHD medications.

There are some doctors who are willing to write prescriptions for Modafinil for their patients with ADHD, especially in cases where amphetamine and methylphenidate based treatments have either had serious side effects, or have not worked as well as wanted. Off-label prescriptions like this are entirely legal, but not all doctors will write them, and it can be challenging to find one who will.

Modafinil as a Nootropic Smart Drug

The other most common off-label use of Modafinil is one that typically prescriptions are never written for: cognitive enhancement. For occasional use, Modafinil has proven advantageous to students and other individuals working in a range of high paced environments. Many in the financial industry have admitted to taking Modafinil as a nootropic drug to improve their mental performance.

Many users report that Modafinil helps increase their mental energy and alertness, improve their concentration and focus, enhance memory formation and recall, and boost their learning abilities. Note that benefits and side effects may vary from mild to serious depending on a range of variables including factors such as frequency and concentration of dosage.

There has been some research done that backs up the claims of cognitive enhancement made in user reviews. Literature reviews of a variety of research studies have seen general trends showing that Modafinil may improve memory, specifically working memory and episodic memory; however other research has said it does not improve episodic memory. Executive functioning has been seen to improve, especially when planning and completing complex or difficult tasks.

One study gave participants either a placebo or Modafinil and then had them complete a series of neuropsychological tests of memory and attention. It was seen that the Modafinil group had significantly improved performance on tests of digit span memory and visual pattern recognition memory, a stop-signal reaction time test, and a spatial planning task.

A delay in prepotent responses (habitual or ingrained responses that may be counterproductive for a task at hand) was seen in the spatial planning task, on a delayed matching to sample test, and on a decision-making task. While this study was done in neurotypical subjects, the researchers concluded that this delay in impulsive responding shows that Modafinil may be a beneficial treatment for people with ADHD.

Modafinil Legality and Sales in the USA

In the U.S., drugs which are submitted for, and pass, the Food and Drug Administration’s (FDA) approval process are then assigned to specific schedules (lists) according to the severity of potential side effects and potential for addiction.

Modafinil is classified as a Schedule IV drug, meaning individuals must have a doctor’s prescription in order to legally buy, use or possess it. It also means that Modafinil cannot be imported unless the retailer is a registered importer by the DEA.

The cost of Modafinil from brick and mortar stores in the USA can be quite high, especially for the name brand version Provigil. A 30-day supply of 100 mg Provigil tablets can run between $950-$1000. Generic Modafinil is often much cheaper, but is still quite expensive at between $375-$560 for a 30-day supply of 100 mg pills.

There are a variety of free coupons available online which can help offset the cost of generic Modafinil. Additionally, some people will find Modafinil from online pharmacies for a significantly cheaper price than their local pharmacy.

There are some legitimate online pharmacies out there that require a prescription to buy, and that sell a reputable product. However, there are also a larger number of online pharmacies out there that do not require a prescription.

The section below will discuss some of the issues that can occur when you order Modafinil online from online pharmacies like these.

Buying Modafinil Online Without a Prescription

Some Modafinil users have reported having successfully imported small quantities from online providers without a prescription. However, buying Modafinil in this manner is not always all that it seems. Importing Modafinil from unregistered retailers is not recommended as it poses both a monetary and health risk.

There are online pharmacies in some countries that will legally sell Modafinil without a prescription. Modafinil is an over-the-counter drug in a few countries around the world including India and Mexico.

It is fully legal for stores from these countries to sell Modafinil without requiring you to provide a prescription. However, there are two main issues with these sorts of vendors: quality of product, and actually being able to import the product to the USA.

These sorts of online pharmacies do not typically have stringent quality assurance procedures in place. They often will not have Certificates of Analysis available for customers to review, or any sort of GMP certification from their manufacturers. Because of this, it can be hard for you to know that you are receiving the products you ordered.

However, these issues of product quality are only going to become an issue once you have the Modafinil you bought online, which is often a large issue in itself. You are only legally allowed to import prescription drugs with a doctor’s prescription.

Customs agents are likely to stop packages from other countries that they suspect contain drugs and you may have to prove you have a prescription to have them released to you. If you do not in fact have a prescription than you will lose out on the money you spent on the product and potentially get up on a DEA watchlist (this is a rare occurrence, but can happen).

Because of the issues surrounding actually getting the products you bought, and then knowing the purity of said products, many people who are interested in experiencing Modafinil’s benefits but cannot get a prescription will instead try a legal non-prescription alternative, such as Adrafinil or one of the Racetams.

Using Adrafinil vs. Modafinil

Due to the restrictions placed on purchasing Modafinil in the U.S., many users have opted to purchase Adrafinil as it is classified as an unregulated, unscheduled compound by the FDA and does not require a prescription.

It is readily available from many online retailers in both tablet and bulk powder forms. Adrafinil is sold under several brand names, but all will specifically list Adrafinil in their description.

A few common names for Adrafinil are Olmifon, Noofon, and Neuroforce. Several online companies offer this drug in bulk powder form.

It is recommended, if buying bulk powder, to research the seller thoroughly through online user reviews before ordering to assure the best possible experience and product.

As discussed earlier, Adrafinil is the prodrug to Modafinil, and breaks down in the body into this active component. Using it as an alternative is a simple way to try and experience the effects of Modafinil.

Adrafinil is less potent than Modafinil. Because it is not a perfect conversion of Adrafinil to Modafinil, it requires a larger dose in order to produce the same results. It must be noted that there are additional risks associated with taking Adrafinil; taking this drug over a long period of time can take a toll on the liver which is often diagnosed by increased liver enzymes.

It is recommended that individuals talk with their doctor about the use of Adrafinil. It is recommended that users have blood work done every 30-60 days if they plan to use Adrafinil with any frequency.

Most people instead tend to use Adrafinil on an occasional basis, perhaps to assist with the odd school or work related project or exam.

Other Modafinil Nootropic Alternatives

Another nootropic group of compounds that some people will use as an alternative to Modafinil are the Racetams. The Racetams are a family of substances that are all related to the parent compound Piracetam.

Piracetam was originally developed in the 1960s by Corneliu Giurgea for the Belgian pharmaceutical company UCB. He coined the term “nootropic” to describe this newly developed compound, which is from Greek origins and means “to bend the mind.”

Piracetam is the first and most widely used Racetam. It has been seen in research to have effects on the cholinergic neurotransmission system in the brain and central nervous system. It stimulates the release of Acetylcholine; this can lead to greater neuroplasticity, which has been related to enhanced learning and memory retention.

Since the development of Piracetam, more potent derivatives including Aniracetam, Oxiracetam, Pramiracetam, and Phenylpiracetam have been developed. Each of these compounds builds on the effects of Piracetam, and most have effects unique to themselves.

For example, Aniracetam is considered a more potent version of Piracetam, and it has been seen to increase concentration and focus by acting as an AMPA receptor agonist. Oxiracetam is considered an even stronger analog of Piracetam, and it has been seen to increase ATP levels in the brain, leading to enhanced mental energy and motivation.

Any of the Racetam class of compounds would be a good alternative to Modafinil for those who cannot get a prescription and do not want to risk ordering from an online pharmacy overseas.

Drug Side Effects

If you do decide to try and buy Modafinil from an overseas online pharmacy, then you run the risk of receiving a product that may contain harmful contaminants. These fillers and foreign substances could make you ill and cause adverse side effects.

If you do receive pure Modafinil from one of these vendors, or you have a prescription and purchase it legally somewhere, there are still some side effects to be aware of. Modafinil is generally well tolerated, but mild side effects have been fairly frequently reported.

Some of the most commonly reported side effects include:

• headaches
• nausea
• anxiety and/or nervousness
• heartburn
• indigestion
• stomach upset
• vomiting
• diarrhea
• dry mouth
• dry skin
• back pain
• insomnia

Some people experience side effects when they first start taking Modafinil as their bodies adjust to the drug. These side effects typically diminish after a couple of weeks.

For some people, a standard dosage may be too high and cause them to experience side effects. Using a lower dosage for a while and then slowly increasing the dosage back to normal may help.

Insomnia is typically caused by taking Modafinil too late in the day. Modafinil is a wakefulness promoting agent, even if this is not the primary reason it is taken. It has a long half-life of up to 15 hours, and therefore if taken later in the day can cause sleep disturbances at night. It is recommended to take your dosage in the morning to avoid insomnia.

There are some rare, but serious skin conditions to be aware of with Modafinil use, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. There is strong evidence that some people have a genetic predisposition that puts them at a higher risk of developing these conditions when they take certain medications, including Modafinil.

Stevens-Johnson syndrome is the least severe (but still potentially deadly) condition, and is also the most common of the three. Symptoms include fever, sore throat, body aches, chills, and a red/purple rash that spreads and blisters, mainly located on the skin and mucous membranes of the mouth, nose, eyes, and genitals.

If you experience these symptoms than seek immediate medical attention and stop taking Modafinil.

In Summary

Modafinil is a wakefulness producing agent which has been found to improve the user’s motivation. While Modafinil is legal in the U.S., a prescription is needed to buy it locally or to import it. In the U.S., Modafinil is classified as a Schedule IV substance which places some limitations on who can possess and use it.

For those who cannot get a Modafinil prescription and who sometimes need something to fight both fatigue and lack of motivation, there is the legal option of purchasing Adrafinil. Adrafinil is available online through reputable sources and we recommend it be reserved for those special cases when you really need the extra push. Another non-prescription nootropic alternative is one of the Racetams.

Both Modafinil and Adrafinil are useful drugs which should be taken only under the supervision of a doctor who can monitor for side effects and any other potential issues.

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