Modafinil Schedule: Is Modafinil A Controlled Substance?

 

Modafinil is a non-amphetamine central nervous system stimulant (CNS) that promotes wakefulness in people suffering from extreme daytime sleepiness. It is sold under a variety of brand names, including Modalert. Its off-label benefits have gained huge popularity making it the 302nd most commonly prescribed medication in the United States, with just over 1,000,000 prescriptions [1].

With an increase in its uses, is Modafinil a controlled substance is a question that most people wonder about. Thus this blog aims to explore if Modafinil is a controlled substance along with its schedule and legal status. 

 

Modafinil and Controlled Substance- An Overview

Originally developed by French neuroscientist Michel Jouvet and Lafon laboratories in the 1970s, Modafinil is a Central Nervous System stimulant.  It is used in the treatment of extreme daytime sleepiness caused due to obstructive sleep apnea, narcolepsy, and shift work sleep disorder.

Controlled substances or drugs are compounds whose possession, manufacturing, and use are regulated by the government [2]. 

 

FDA Approval Process- Is Modafinil Use Approved?

 

 

YES, Modafinil's medical use is approved by the FDA in the year 1998. The classification of Modafinil or any controlled substance into different schedules is determined by two federal agencies- 

• Drug Enforcement Agency (DEA)

• Food and Drug Administration (FDA) [3]. 

The addition and removal or any change of a controlled substance is carried out by the DEA and the Department of Health and Human Services (HHS). All the data and information are collected by the DEA and followed by the FDA for the evaluation of its scientific and medical information. The final report is then proposed by the DEA based on the findings. 

The FDA (Food and Drug Administration) approval process is a series of steps that the manufacturer should go through to get approval in the USA. The FDA approval of Modafinil along with its brand drugs has been approved through the following steps [4]. 

1. Preclinical Testing- Before any human trials, the product or medication is first tested on animal models to get the initial data on analyzing its safety and effectiveness. 

2. Investigational New Drug (IND) Application- The pharmaceutical company submits preclinical data and a plan for human clinical trials which is then reviewed by the FDA [5]. 

3. Phase 1 Clinical Trials- Evaluate the drug safety, dosage, and side effects in a small group of healthy humans. 

4. Phase 2 Clinical Trials: The drug is tested on a larger group of humans for determining the effectiveness and safety of the proposed dosage of the drug. 

5. FDA review and decision. 

 

Is Modafinil A Controlled Substance?

Yes, Modafinil is a controlled substance, a drug classification that has the potential to cause mental and physical dependence. 

The Controlled Substance Act categorized medicines and other substances into five different schedules. The scale starts from Schedule I – the most dangerous drugs which are likely to cause dependence and can be abused to Schedule V, which has a low potential for abuse and dependence. Each year the Drug Enforcement Administration publishes an updated list.

 

Patent Infringement Lawsuits For Generic Versions Of Modafinil 

The original patent for Modafinil by Cephalon expired in 2015 which allowed other pharmaceutical companies to manufacture and market its generic version [6]. 

Cephalon, however, filed a lawsuit against several generic drug manufacturers when they manufactured and introduced their own version of the Nootropic before the patent of Cephalon expired. In response to the lawsuit, the manufacturers reached a settlement with Cephalon. 

Thus, Cephalon made an agreement with four generic manufacturers Ranbaxy Laboratories, Teva, Watson Pharmaceuticals, and Barr Pharmaceuticals between 2005 to 2006 to delay the sale of the generic Modafinil in the USA until 2012 [1]. 

Following the expiration of the patent, there were several patent infringement lawsuits related to specific manufacturing processes, formulations, and other aspects of the generic version of Modafinil. 

 

Modafinil Drug Class- Does It Affects The Nootropics Classification? 

Modafinil belongs to a drug class known as eugeroics. They are wakefulness-promoting agent that is prescribed for the treatment of sleep disorder such as Obstructive sleep apnea, Narcolepsy, and shift work sleep disorder.

Modafinil is also determined as a Nootropic that is proven to enhance the cognitive functioning of the user. However, the drug class of Modafinil does not play a significant role in determining its classification. 

Provigil Drug Class

Provigil is the brand drug of Modafinil and thus belongs to the same drug as its generic. Meaning Provigil is approved by the FDA as eugeroics and further plays a crucial role as a Nootropic. 

 

Modafinil Schedule

Modafinil is classified as a Schedule IV controlled substance by the U.S. Drug Enforcement Administration in the year 1999. Although schedule IV controlled substances are not available over the counter, they are considered to have a low possibility of causing dependence and abuse [7].

Abuse And Addiction Potential Of Modafinil 

The risk of experiencing Modafinil dependency is low and people with a history of drug dependence are more likely to experience addiction. 

According to Nora D. Volkow, Director of the National Institute on Drug Abuse (NIDA), Modafinil has a similar effect on the dopamine center of the brain as cocaine. It thus triggers the release of a neurotransmitter (dopamine) that is known to cause a feeling of pleasure [8]. 

Clinical studies evaluating the addictive potential of Modafinil- 

A study published in the Psychopharmacology Journal suggests that Modafinil is not a psychostimulant drug and do not have an addictive property. The study also indicates that the Nootropic lacks any propensity for addiction [9].

Another study involving 24 male volunteers with a history of drug abuse supported the theory of low risk of abuse associated with Modafinil.  

 

The propensity of Modafinil dependency based on gender-

A study in the Journal of Psychopharmacology, Modafinil use, and dependency is more common and frequent in women than men [9]. 

 

Is Provigil A Controlled Substance?

Yes, similar to its generic version, Provigil is a controlled substance. 

The disclaimers and regulations that must be followed while taking a controlled substance, including Modafinil, Modakert, and Provigil are listed below. 

• The long-term use of Modafinil or its brand drugs is not recommended by the FDA. 

• It is not advisable to share the Nootropic with others without consulting a doctor. 

• Modafinil, Provigil, and Modalert are not available over the counter. 

• Modafinil can lower blood pressure, cause agitation, weight loss, dizziness, etc and thus require regular health monitoring. 

 

Is Modafinil Legal?

The legal status of Modafinil differs depending on the country and the state. 

• Australia- Schedule 4 prescription drug.

• Canada- Modafinil is not a controlled drug in Canada. It is a Schedule F prescription medication. 

• Japan- Schedule I psychotropic drug. 

• China- Class I psychotropic medication and is not prescribed for over 3 days. 

• Russia- Schedule II controlled substance.

• Sweden- Schedule IV prescription drug. 

Modafinil or its brand medication is not classified as a controlled substance in the following countries. 

• Denmark

• Finland.

• Mexico. 

• UK

• South Africa. 

Is Modafinil Legal In The US?

The simple answer is Yes! A person in the United States can legally use the wakefulness-promoting agent by having a doctor's signed prescription and purchasing it from a licensed pharmacy.

 

Legal Law And Regulations For Modafinil In The USA

• It is legal to import Modafinil or Modalert without a prescription from online pharmacies and vendors registered under the DEA, such as Health Naturo. 

Healthnaturo retails genuine and authentic Modalert online at a discounted price in the USA. The Nootropic is directly obtained from the Manufacturer and is shipped following a proper quality control check. 

• An individual can bring Modafinil from a foreign country into the USA with a valid medical prescription [1]. 

• Under the US Pure Food and Drug Act, pharmaceutical companies are not allowed to market the Nootropic for its off-label uses  [1].

 

Modafinil Regulation In Sports 

Modafinil medication is included on the prohibition list of the World Anti-Doping Agency (WADA) and is considered a banned substance in sports. The agency listed Modafinil in their prohibited list on August 3, 2004, 10 days before the Summer Olympics of 2004 [1]. Thus, its use is not allowed by most sports organizations and athletic governing bodies.

The reason for including Modafinil as a doping agent is due to its ability to prolong exercise time to exhaustion. The Nootropic also reduces the perception of effort to maintain the threshold. 

 

Modafinil Controlled Substance - Our Final Thoughts

Modafinil is a well-tolerated wakefulness-promoting agent that is classified as a schedule IV controlled substance with a low risk of abuse and dependency. 

To sum it up, let us see why Modafinil is a Controlled substance.

• Potential for misuse- Modafinil and its brand medication can affect the dopamine level and cause a sense of pleasure thus making it a potent substance for misuse. Also, the off-label use of the Nootropic makes it very common for beginners to take the wrong dose resulting in misuse. 

• Habit forming- Studies and clinical trials show that Modafinil has a lower risk of causing dependency and abuse. 

• Euphoric effect- The Modafinil intake can affect the level of dopamine in the body which can thus result in euphoria or a feeling of pleasure thus making it a potential substance for abuse.