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The most obvious reason that people choose to buy generic Nuvigil, also known as Armodafinil, is price.
As with all prescription medications, generic versions boast identical benefits to their name brand counterparts at a fraction of the cost.
While the generic version of Nuvigil may save you some money, it still may not be any easier to get than brand name Nuvigil, which itself is notoriously hard to obtain a prescription for.
Offshore pharmacy websites may offer deals on products like these, but at what cost?
Let’s take a look at the safety and legal concerns around buying Nuvigil generic pills from one of these sites, along with user recommendations for comparable nootropic supplements which are easier to buy legally.
Energy
Cognition
Motivation- Wakefulness-boosting stimulant
- Enhances motivation and focus
- Shown to boost mental performance
Generic Nuvigil
Related Topics
- What is Armodafinil?
- What is Nuvigil?
- Armodafinil vs. Modafinil
- User Review
- Typical Nuvigil Experiences
- How it Works
- Nuvigil for ADHD
- Effects on Depression & Anxiety
- Dosage Recommendations
- How to Take
- Reported Side Effects
- Withdrawal & Tolerance
- Prescription Information
- Buying Nuvigil
- Generic Nuvigil Brands
- Is Armodafinil Legal?
- Is Nuvigil Safe?
- Comparison to Adderall
Generic Nuvigil, or Armodafinil, may be sold under simply its compound name Armodafinil, or other trade names such as Waklert or Armod.
Cephalon’s exclusivity patents on Armodafinil Nuvigil expired in 2016, which has allowed generic Nuvigil Armodafinil formulations to become available for sale in the USA. There are currently three companies with FDA approved generic Armodafinil formulations.
The same thing happened when Modafinil (Provigil) was expected to be made generic ahead of its patent expiring. Modafinil is the parent drug from which Nuvigil was derived.
Before it was set to expire, the manufacturer Cephalon sought a court injunction to prevent generic forms from being sold in the USA, thus extending their monopoly. They won that court battle initially which is why the release of Provigil generics was delayed by several years.
In fact, it was the scheduled expiry date on Modafinil’s patent that caused the pharmaceutical company Cephalon to pursue the development of Armodafinil in the first place.
Their researcher’s discovered that Armodafinil could deliver the same effects of Modafinil at a smaller dosage. The difference in the drug was sufficient for many doctors to begin prescribing the more expensive Nuvigil over Provigil which was on track to be made generic.
Nuvigil Versus Provigil Differences
Nuvigil is very similar to the brand name product Provigil. It’s natural to be confused by the distinctions among them.
Modafinil was first discovered by scientists at the French pharmaceutical company Lafon Laboratories in the 1970s due to testing on a related compound, Adrafinil. Adrafinil is one of a series of benzhydryl sulfinyl compounds that was developed in 1974.
Testing that was done to determine how Adrafinil works in the body found that this compound is broken down in the liver into its component parts. The primary active compound in Adrafinil is Modafinil.
Both Adrafinil and Modafinil were first tested in humans as therapies for the severe sleep disorder narcolepsy. Adrafinil was approved as a narcolepsy treatment in France in 1986; Modafinil was later approved as a treatment in France in 1994, and in the Unites States in 1998.
Lafon was bought by the pharmaceutical company Cephalon in 2001. Ahead of Cephalon’s patent running out on Modafinil, it decided to create a new version of this compound to help them maintain an exclusive share of the market.
Modafinil is comprised of two nearly identical stereoisomers. These are called enantiomers, and they are mirror image copies of the same molecular structure.
There is the R-Modafinil enantiomer and the S-Modafinil enantiomer. Research has determined that the R-enantiomer is the more pharmacologically active, stable, and longer-lasting stereoisomer of Modafinil.
Cephalon therefore re-designed the formula of Modafinil into a purer version by isolating the R-isomer alone. This new enantiopore version, called Armodafinil (named for R-Modafinil), produced the same exact wakefulness and attention span effects as Modafinil, but in higher strength and smaller doses.
Both of these generics were rebranded and sold in the U.S. by Cephalon as Provigil and then Nuvigil. All four compounds are controlled substances which require a prescription to buy.
How Nuvigil Effects Work
While the exact mechanisms of drugs like Armodafinil (generic Nuvigil) and Modafinil (generic Provigil) are still somewhat of a mystery, we do know that they are in a class known as eugeroic drugs.
These “arousal” drugs simulate the stimulation of Dopamine and Norepinephrine receptor sites without actually spiking those hormones. This, plus increased release of hypothalamic Orexin and Histamine, can prompt the sleep centers of the brain to reduce perception of tiredness.
Instead, the user experiences a pervasive sensation of wakefulness, and a laser-like mental focus. Unlike amphetamines, eugeroic drugs do not result in hormone depletion, “crashing” and withdrawals. This is why they can be taken safely every day, and do not seem to interfere with normal sleep when taken at appropriate times and dosages.
- Increases energy, wakefulness and motivation
- Boosts mental performance and focus
- Supports memory and cognition
Generic Nuvigil for Sleep Disorders
Like Provigil before it, Nuvigil and generic Nuvigil sources have been categorized as Schedule IV prescription only medications by the FDA in the United States. Nuvigil is approved to treat certain serious sleep disorders, specifically narcolepsy and shift-work sleep disorder, and as an adjunct treatment for obstructive sleep apnea/hypopnea syndrome.
In one double-blind placebo-controlled clinical trial on narcolepsy, patients were given either a placebo or Armodafinil. It was observed that the Armodafinil patients has significantly improved mean sleep latency times compared to placebo patients, as measured on the Maintenance of Wakefulness Test.
In a study using Armodafinil for shift-work sleep disorder, mean sleep latency times as measured by the Multiple Sleep Latency test were significantly improved in the Armodafinil patients compared to the placebo patients, and patient diaries reported improved sleepiness during work shifts.
In some cases, people with obstructive sleep apnea/hypopnea syndrome still experience residual excessive daytime sleepiness even when their condition is being treated with standard methods (using a nCPAP machine at night). Armodafinil has been used in these patients to reduce this sleepiness and improve wakefulness.
One study found that compared to placebo patients, Armodafinil patients had significantly improved mean sleep latency times as measured on the Maintenance of Wakefulness Test.
Off-Label Benefits
The off-label benefits of Nuvigil are so named because they were not the original intent of the medication. However, these benefits, which could almost be considered side effects, are what draw most new users to explore generic Nuvigil products.
These benefits include an incredible boost to concentration. Tasks which take many hours are very easy to focus upon and execute with precision.
The typical workday remains engaging and easy to focus upon, despite any distractions, boredom, stray thoughts, or frustrations that might normally impede performance.
These benefits can be useful for college students, businesspeople, programmers, designers, and any profession that requires a lot of attention to detail. Sufferers of ADD and ADHD might find relief from a chaotic mind. And for those in fitness training, appetite is suppressed, leading to possible weight loss.
There have not been an substantial research studies done looking at the cognitive enhancing effects of generic Nuvigil, but these effects have been studied in trials focused on sleep disorders.
In one study in shift-work sleep disorder, it was seen that scores on standardized tests of attention and memory from the Cognitive Drug Research battery of tests were significantly improved compared to placebo patient scores. Similar results were seen in a study using Armodafinil to treat narcolepsy.
Does Generic Nuvigil Have Side Effects?
As with any prescription medication, individual sensitivities can determine if side effects are significant. However, for most people, the use of eugeroic drugs like generic Nuvigil, Modafinil, Adrafinil, etc, is very well-tolerated with minimal side effects.
Some of the most commonly reported mild side effects from pooled double-blind placebo-controlled studies and user review online include:
- headaches
- nasuea
- dizziness
- anxiety
- dry mouth
- diarrhea
- depression
- insomnia
- indigestion
- fatigue
- upper abdominal pain
- heart palpitations
There is typically a period of adjustment for most people when they begin taking any new prescription medications. These side effects typically subside in 2-3 weeks. If they do not, then speak to your doctor about trying a lower dosage.
Especially with stronger variations such as Nuvigil , it is typically advised to start with lower doses to gauge the body’s reaction. A dose of 50 – 100 mg of Nuvigil is considered a low “baseline” dose for adults and is a good starting point to avoid side effects.
These drugs are contraindicated for anyone taking blood pressure medicine, liver medicine, or alpha blockers. In very rare cases, they can cause some over-excitement, anxiety in the mind, and a greater propensity for bruising and bleeding in the body.
There is a the possibility of developing a rare, but serious skin and mucous membrane reaction, such as Stevens-Johnson syndrome when taking Nuvigil. There is strong evidence that suggests certain people have a genetic susceptibility to developing these conditions when they take certain medications, including Nuvigil and Provigil.
Speak with your doctor immediately and stop taking Nuvigil if you develop flu-like symptoms such as a fever, body aches, and a sore throat, as well as a red or purple spreading, blistering rash.
Buying Generic Nuvigil Legally
In order for a drug to be labelled a generic form, it has to contain the same ingredients in the same dosages with the same purity specifications as the original brand-name product.
That means that any generic Nuvigil pills you purchase must contain the same amount of active Armodafinil as the real thing sold by Cephalon would.
Even though generic Nuvigil has an excellent safety record and rarely produces serious side effects, it is still tightly regulated by the FDA and is considered a Schedule IV controlled substance. This means that you must have a prescription to buy it legally in the United States.
As prescriptions are typically only given to patients with sleep disorder diagnoses, it is exceedingly difficult for the typical nootropic user to legally acquire the drug. Many doctors and health insurance programs will not approve the use of a medication for off-label purposes – which in this case includes most of the cognitive benefits of the drug other than wakefulness.
Buying Generic Nuvigil Without a Prescription
Because getting a prescription for off-label uses of generic Nuvigil is nearly impossible, some people are tempted to buy this drug without a prescription from international online pharmacies. Online pharmacies located in countries such as Mexico and India, where Modafinil and Armodafinil are over-the-counter medications, can legally sell these drugs without a prescription.
You can purchase Nuvigil or Armodafinil legally online without a prescription from these international pharmacy websites – with a catch. Once you ship your order back to the United States, the contents once again are under the jurisdiction of US FDA laws, and become illegal to possess without a prescription.
This means that US Customs can and will confiscate your package if you cannot prove you have a prescription, and your investment will be lost. Similar guidelines apply to individuals importing this drug into the United Kingdom, and importing prescription drugs like generic Nuvigil is not permitted in Canada.
When retail prices for Nuvigil go as high as $300 for 30 250 mg pills, this financial risk is too high to make this method of purchase viable.
Furthermore, the quality of pills which are shipped is in question. Countries like Mexico and India, home to these sites, do not regulate pharmaceutical production at U.S. standards. There are no assurances of Good Manufacturing Practices (GMP) in place in many of these facilities.
Pills may be compromised with contaminants or even completely fake. There are very often no Certificates of Analysis available to prove the authenticity and purity of these products, and almost never for each batch produced.
Buying generic Nuvigil from these sorts of sites is overall not recommended, as there are too many risks inherent to the process. Rather, people who are interested in experiencing the nootropic effects of Nuvigil should consider using one of the non-prescription alternatives suggested below.
Non-Prescription Alterantives
So, anyone who is curious to try generic Nuvigil is left with one good option – explore the legal nootropics that produce similar or even identical effects as Nuvigil.
In particular, the supplement Adrafinil is popular with Nuvigil users because it is literally the pre-cursor to Modafinil. The liver converts Adrafinil into Modafinil, which as we know is the generic name for Provigil and is the close chemical analog of Nuvigil.
Adrafinil ultimately produces the same effects as Nuvigil, Provigil, and their generics, however it does not require a prescription to buy. Onset times are slightly longer with this method, and care needs to be taken to avoid over-stressing liver function. It is recommended that Adrafinil only be used on an occasional basis when needed for an extra mental boost.
Another nootropic alternative that some people like to use instead of generic Nuvigil is one of the Racetams. This family of compounds are all based off of the first nootropic ever developed, Piracetam.
These compounds have positive effects on Acetylcholine, a neurotransmitter that has effects on executive function, learning ability, and memory. The most common derivatives of Piracetam – Aniracetam, Oxiracetam, Phenylpiracetam, and Pramiracetam are all more potent than their precursor compound.
Adrafinil and the Racetams are all considered unregulated, unscheduled compounds in the US and are legal to buy, own, and use without a prescription. FDA laws limit the sale of compounds like these, so you will need to turn to specialized online nootropic stores to buy them.
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- Harsh JR, Hayduk R, Rosenberg R, Wesnes KA, Walsh JK, Arora S, Niebler GE, Roth T. The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy. Curr Med Res Opin. 2006
- Calabrese JR, Frye MA, Yang R, Ketter TA; Armodafinil Treatment Trial Study Network. Efficacy and safety of adjunctive armodafinil in adults with major depressive episodes associated with bipolar I disorder: a randomized, double-blind, placebo-controlled, multicenter trial. J Clin Psychiatry. 2014
- Darwish M, Bond M, Yang R, Hellriegel ET, Robertson P Jr. Evaluation of the potential for a pharmacokinetic drug-drug interaction between armodafinil and ziprasidone in healthy adults. Clin Drug Investig. 2014
- Liira J, Verbeek JH, Costa G, Driscoll TR, Sallinen M, Isotalo LK, Ruotsalainen JH. Pharmacological interventions for sleepiness and sleep disturbances caused by shift work. Cochrane Database Syst Rev. 2014
- Howard R, Roth T, Drake CL. The effects of armodafinil on objective sleepiness and performance in a shift work disorder sample unselected for objective sleepiness. J Clin Psychopharmacol. 2014
- Wisor JP, Dement WC, Aimone L, Williams M, Bozyczko-Coyne D. Armodafinil, the R-enantiomer of modafinil: wake-promoting effects and pharmacokinetic profile in the rat. Pharmacol Biochem Behav. 2006
- Roscoe JA, Garland SN, Heckler CE, Perlis ML, Peoples AR, Shayne M, Savard J, Daniels NP, Morrow GR. Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. J Clin Oncol. 2015
- Lower EE, Malhotra A, Surdulescu V, Baughman RP. Armodafinil for sarcoidosis-associated fatigue: a double-blind, placebo-controlled, crossover trial. J Pain Symptom Manage. 2013
Article last updated on: April 16th, 2018 by Nootriment
1 Comment
http://newsroom.mylan.com/2016-06-01-Mylan-Launches-First-Generic-of-Nuvigil-Tablets
a generic is now available