Modafinil was classified as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA) in the year 1999. This indicates that it is a prescription medication that has a lower risk of abuse.
Controlled substances are drugs presenting a risk of abuse and threat to public health with a high therapeutic value.
Modafinil is a non-amphetamine central nervous system (CNS) stimulant. It promotes wakefulness in people suffering from extreme daytime sleepiness. Modafinil is sold under a variety of brand names, including Modalert.
Understanding the legal status of Modafinil is essential due to its increased use and classification as a controlled substance. This classification impacts its availability, prescription use, and legal consequences associated with its use. Here, we will explore the Modafinil schedule and whether Modafinil is a controlled substance.
Understanding Modafinil And Controlled Substances
Modafinil was originally developed in the 1970s by French neuroscientist Michel Jouvet and Lafon laboratories. Its mechanism of action (MOA) involves enhancing neurotransmitters or brain chemicals.
Modafinil is used to treat excessive daytime sleepiness (EDS) caused by obstructive sleep apnea, narcolepsy, and shift work sleep disorder (SWSD). It also has several other off-label benefits, such as improving cognition, focus, and productivity. Off-label benefits of Modafinil have gained huge popularity, making it the 302nd most commonly prescribed medication in the United States [1].
Off-label benefits refer to the medication's positive effects, which may not be approved by regulatory authorities. However, doctors find it beneficial to treat certain conditions through clinical experience, research, or evidence.
Controlled Substances
Controlled substances or drugs are compounds whose possession, manufacturing, and use are regulated by the government [2]. According to the Controlled Substance Act, medicines are categorized into five different schedules from I to V.
Schedule I medications are more likely to cause dependence and abuse, while Schedule V medications have a low potential for the same.
In different countries, medications are categorized into different schedules based on their potential for abuse, dependency, and health risks. The DEA publishes an updated list each year to ensure safety and appropriate use.
Is Modafinil A Controlled Substance?
Yes, the Drug Enforcement Administration has classified Modafinil as a Schedule IV controlled substance. This classification indicates that the Nootropic has a low potential for abuse and addiction compared to higher scheduled drugs like Schedule I or II [7]. However, it is still regulated and requires a prescription for legal use.
The specific schedule classification of Modafinil may vary slightly between countries, so it's essential to check with your local regulations.
Why Is Modafinil A Controlled Substance?
Below are a few factors why Modafinil is considered a controlled substance-
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Stimulant Effects: As mentioned earlier, Modafinil is a CNS stimulant that can lead to its misuse as a performance-enhancing drug or for recreational purposes.
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Potential for Dependence: Modafinil has a lower risk of dependence compared to traditional stimulants. However, long-term or taking high doses can lead to dependence or addiction.
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Off-Label Use: The increased off-label use may increase the risk of misuse and side effects contributing to its controlled substance classification.
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Recreational Use: Some individuals may misuse Modafinil for recreational use due to its sedative and euphoric effects. This can lead to health risks and addiction.
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Regulatory Compliance: Regulatory bodies like the FDA strictly monitor stimulants to ensure safe and appropriate use. Categorizing Modafinil as a controlled substance allows control over its distribution, prescription, and use.
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Public Health Concerns: Modafinil's controlled substance status helps to address public health concerns related to substance abuse, addiction, and potential adverse effects associated with its misuse.
FDA Approval Process- Is Modafinil Use Approved?
Yes, the Food and Drug Administration (FDA) approved Modafinil's medical use in 1998. Two federal agencies determine the classification of Modafinil or any controlled substance-
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Drug Enforcement Agency
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Food and Drug Administration [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 approval process is a series of steps that the manufacturer must follow to get approval for marketing and sale in the United States. The FDA has approved Modafinil and its brand drugs through the following steps [4].
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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.
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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].
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Phase 1 Clinical Trials- Evaluate the drug safety, dosage, and side effects in a small group of healthy humans.
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Phase 2 Clinical Trials- The drug is tested on a larger group of humans to determine the effectiveness and safety of the proposed dosage.
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FDA review and decision- The FDA then reviews the data to assess the drug's safety, efficacy, and benefits. Based on the review, the FDA decides to either approve or deny the product.
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Post-Market monitoring- After approval, the FDA monitors to identify and address any unexpected side effects.
Modafinil Addiction And Abuse Potential
Modafinil has a lower risk for addiction compared to other stimulants.
A study published in the Psychopharmacology Journal suggests that Modafinil is not a psychostimulant drug and does not have an addictive property. The study also indicates that the Nootropic has no addiction risk. Additionally, Modafinil use and dependency are more common and frequent in women than men [9].
Inappropriate and excessive use or individuals with a history of drug dependence are more likely to experience addiction.
Taking Modafinil for purposes other than its intended prescription use and dosage or misuse can lead to abuse. Misusing Modafinil can cause various health risks, including heart issues, anxiety, disrupted sleep patterns, and interactions with other medications.
Hence, Modafinil should be used after consulting a healthcare professional to ensure safe and responsible use, minimize risks, and address any addiction-related concerns effectively.
Modafinil Regulation In Sports
Modafinil is a prohibited substance in sports, as listed by the World Anti-Doping Agency (WADA) on August 3, 2004 [1]. Thus, most sports organizations and athletic governing bodies do not allow its use.
Modafinil is included as a doping agent because it helps athletes exercise for longer periods without feeling tired. It also makes it easier to maintain a certain level of effort during exercise. However, using Modafinil in sports is against the rules because it gives an unfair advantage and can be harmful to health if not used properly.
Legal Status Of Modafinil
The legal status of Modafinil differs depending on the country and the state.
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Legal status of Modafinil in Australia- Schedule 4 prescription drug.
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Legality of Modafinil in Canada- Modafinil is not a controlled drug in Canada. It is a Schedule F prescription medication.
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Japan- Schedule I psychotropic drug.
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China- Class I psychotropic medication and is not prescribed for over 3 days.
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Russia- Schedule II controlled substance.
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Sweden- Schedule IV prescription drug.
Modafinil or its brand medication is not classified as a controlled substance in the following countries.
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Denmark
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Finland.
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Mexico.
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UK
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South Africa.
Is Modafinil Legal In The US?
Yes, a person in the United States can legally use the wakefulness-promoting agent, provided the individual has a doctor's signed prescription and purchases it from a licensed pharmacy.
Legal Law And Regulations For Modafinil In The USA
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It is legal to import Modafinil or Modalert without a prescription from online pharmacies and vendors registered under the DEA.
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An individual can import Modafinil from a foreign country into the USA with a valid medical prescription.
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Under the US Pure Food and Drug Act, pharmaceutical companies are not allowed to market the Nootropic for its off-label uses [1].