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Is Modafinil a Controlled Substance?

Executive Summary

  • A controlled substance is a drug or other substance that the governments strictly regulate due to the possibility of abuse or addiction. The legislation covers the substance’s production, use, handling, storage, and distribution. Opioids, stimulants, depressants, hallucinogens, and anabolic steroids are examples of controlled drugs.
  • Qualified healthcare professionals can only prescribe controlled medications with known medical purposes such as Valium, and Ritalin. Other controlled drugs, like heroin and lysergic acid diethylamide have no acknowledged medicinal use so The United States Food and Drug Administration (FDA) prohibits them.
  • The United States Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), has categorized modafinil as a schedule IV controlled substance (prescription medication), which is a classification for medications having legal medical applications and little risk for addiction. The UK, Germany, Australia, India, Canada, and Mexico have approved modafinil as a non-controlled prescription drug.
  • According to the International Narcotics Control Board, modafinil is not regarded as a narcotic or a psychotropic drug.

Modafinil in Scientific Publications

Addictive Potential of Modafinil

In a study published by the Psychopharmacology Journal, scientists aimed to assess modafinil’s potential for addiction and how it reinforced behavior in untrained rats. Additionally, they investigated modafinil’s interactions with cocaine’s enhancing effects.

The study investigated the rewarding and reinforcing effects of a broad range of modafinil dosages in naïve rats using intravenous self-administration and place conditioning experiments.

Researchers examined the influence of modafinil on incentive and reinforcing effects of cocaine in rats trained for cocaine self-administration. They also compared the effects of modafinil with those of haloperidol and amphetamine.

Study Findings

Modafinil is not a typical psychostimulant drug and does not have addictive or reinforcing properties in cocaine-naïve rats. The researchers concluded that when examined in several preclinical models, stimulant-naïve mice lacked any propensity for addiction.

The reinforcing or motivational characteristics of cocaine did not appear to be altered by modafinil when compared to traditional psychostimulants.

Cocaine-induced dose-response reinstatement was not altered by modafinil above saline controls. This study underscores that modafinil is considered as one of schedule IV-drugs with little risk for addiction.

The Abuse Potential of Modafinil

In a study published by the Journal of Psychopharmacology, researchers evaluated modafinil’s abuse potential using methylphenidate as a reference.

Scientists carried out a double-blind, Latin square crossover study with 24 male volunteers who had previously abused multiple drugs, including the stimulant cocaine. Each participant received a single oral dosage of modafinil, methylphenidate, and placebo.

Throughout the 72 hours following each dose, researchers assessed the measurements of subjective, behavioral, and physiological responses at predetermined intervals. Participants discriminated both modafinil and methylphenidate from placebo. They liked the effects of both modafinil and methylphenidate.

Study Findings

Modafinil did not significantly affect the Amphetamine Scale of the Addiction Research Center Inventory, which distinguished itself from methylphenidate.

In contrast to methylphenidate, modafinil had a different profile of physiological effects that exhibited stronger suppression of both seen and reported sleep, less facilitation of orthostatic tachycardia, and less caloric intake reduction.

These results support preclinical pharmacological evidence that modafinil is not an amphetamine-like substance with minimum risk for addiction. This study affirms that modafinil is considered as one of schedule IV-drugs with low risk for addiction.

Implications for the Addictive Potential of Modafinil

In a study published by Frontiers in Pharmacology Journal, researchers aimed to assess the bidirectional rapid-onset cross-sensitization between modafinil and cocaine in male Swiss mice.

A high dosage of modafinil provided as a priming injection caused quick onset behavioral sensitization to challenge injections of modafinil given four hours later.

Additionally, researchers created a bidirectional rapid-onset cross-sensitization between modafinil and cocaine.

Study Consclusions

There were no apparent behavioral effects of the modafinil priming injection and there was a decrease in modafinil plasma concentration after 4 hours of treatment. Therefore, the residual levels of modafinil did not cause these results.

The overall results show that modafinil may be both reinforcing on its own and also boost the reinforcing effects of stimulants like cocaine within hours after dosing. This study emphasizes that modafinil is a schedule IV-controlled substance with minimum or little risk for addiction.

Approved and Investigational Uses of Modafinil

In a study published by Drugs Journal, researchers assessed the approved and investigational uses of modafinil. They examined the use of modafinil in clinical studies based on the findings of , double-blind, placebo, randomized controlled trials found in the MEDLINE database.

Modafinil is approved to treat narcolepsy, excessive daytime sleepiness, excessive sleepiness, shift work sleep disorder, and obstructive sleep apnea. Recent medical studies also indicate that Modafinil is may be effective in treating ADHD, unipolar and bipolar depression.

Study Findings

Clinical trials of modafinil for excessive drowsiness in Parkinson’s disease, cocaine addiction treatment, and cognition in chronic fatigue syndrome had inconclusive results; all trials had relatively small sample numbers.

Until definite evidence is available, it is not recommended to use modafinil for these disorders. They concluded that modafinil may have some abuse/addictive potential although no cases have been reported to date.

Addictive Potential of Modafinil and Cross-Sensitization With Cocaine

In a study published by Addiction Biology Journal, scientists utilized male mice to test modafinil’s capacity to elicit locomotor sensitization following repeated or single dosing. Researchers asses modafinil-induced conditioned location preference and cocaine-induced bidirectional cross-sensitization.

Both recurrent and single modafinil administration at moderate and high dosages resulted in considerable locomotor sensitization that cross-sensitized with cocaine in a bidirectional manner. When researchers administered cocaine and modafinil concurrently to mice, their behavioral sensitization was additive.

Modafinil caused a strong conditioned location preference in mice, which supports behavioral sensitization findings. The current findings provide pre-clinical evidence for modafinil’s addictive potential.

These findings imply that comparable brain substrates are implicated in modafinil and cocaine’s psychomotor/rewarding effects, suggesting that modafinil is considered as one of schedule IV-drugs with low risk for addiction.

Abuse Liability Issues of Modafinil Augmentation Therapy

In a study published by Annals of Clinical Psychiatry, scientist assessed the potential of modafinil for large-scale abuse.

Researchers evaluated evidence from preclinical in vitro and in vivo research, human laboratory studies, and post marketing experiences addressing the possible abuse liability of modafinil.

They found that initial evidence indicates that modafinil has limited potential/possibility for large-scale abuse,

The Cocaine-like Discriminative Stimulus Effects and Reinforcing Effects of Modafinil

In a study published by Psychopharmacology Journal, scientists evaluated the cocaine-like discriminative stimulus effects  in rats and reinforcing effects of modafinil in rhesus monkeys maintained on intravenous cocaine self-administration.

Modafinil, l-ephedrine, and d-amphetamine all resulted in dose-dependent increases in cocaine-lever response. Modafinil caused complete substitution in four of the six rats examined, although the greatest levels of substitution were linked with significant response rate decreases.

Based on the findings of experiments done in conjunction with prazosin, there was little indication that the discriminative stimulus effects of modafinil were caused by α1 -adrenergic activation.

Modafinil and l-ephedrine served as reinforcers in the self-administration method in rhesus monkeys. Modafinil’s reinforcing and discriminative stimulus effects need extremely large doses: 200 times less powerful than d-amphetamine and also less strong than l-ephedrine.

Modafinil, like other CNS stimulants, may act as a reinforcer at high dosages and exhibits some cocaine-like discriminative stimulus effects.

The study concluded that modafinil can mimic the discriminative stimulus effects of cocaine in rats and work as a reinforcer for drug self-administration in rhesus monkeys taught to use cocaine.

Therefore, modafinil should be regarded as a “relatively impotent” stimulant. This indicates that modafinil could be classified as one of controlled substances with little risk for addiction.

Modafinil as a Schedule IV Controlled Substances

The United States Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), has categorized modafinil as a schedule IV controlled substance. Although modafinil is a controlled substance, it is categorized at a lower level of severity and control.

Schedule IV Controlled Substances

Drugs, substances, or chemicals in Schedule IV have low potential for abuse, and may lead to limited physical dependence or psychological dependence.  Schedule IV drugs like Modafinil, Darvon, Xanax, Ativan have currently accepted medical use in treatments in the United States.

An Evaluation of The Drug Abuse Potential of Modafinil

A wide range of research shows that modafinil has a low risk of misuse. Firstly, modafinil’s chemical and pharmacologic characteristics are not conducive to misuse.

Second, preclinical studies show that modafinil in stimulant-naïve animals has minimal to no addictive potential. In rodents and primates having extensive past stimulant exposure, modafinil has modest addictive potential, but only in doses that milligram per kilogram are far greater than that of amphetamine .

In a study published by Psychopharmacology Journal, scientists evaluated modafinil reinforcing effects in rhesus monkeys kept on intravenous cocaine self-administration, using d-amphetamine as positive control. Scientists used modafinil as substitution of cocaine in specific doses (0.03, 0.1 and 0.3 mg/kg per infusion). Modafinil consumption varied from 0.4mg/kg at 0.03 mg/kg per infusion dosage to 34.7 mg/kg at 0.3 mg/kg per infusion dose in all animals. During a single 1-hour session, one monkey took up to 36 mg/kg, while two others took more than 17 mg/kg.

Moreover, they also tested d-amphetamine (0.01 or 0.03 mg/kg per infusion) as positive control in these rhesus monkeys. The 0.03 mg/kg per infusion dose of d-amphetamine tested was linked to prolonged stimulant-related stereotypies and hypervigilant behaviors. After then, the dosage was reduced to 0.01 mg/kg each infusion.

Third, human studies including both non-substance-abusing volunteers and cocaine-using people, indicate that that modafinil has a low abuse potential, as well as having negligible impacts on hemodynamic parameters and hunger. 

Perhaps most crucially, modafinil did not appear to have attracted much interest on the internet, had little financial value in sales, and generated few clinical complaints of misuse in almost four years of post-marketing surveillance, according to a report from the Haight-Ashbury Clinics.

Modafinil Addiction by Sex

According to the study published by the Journal of Psychopharmacology, modafinil usage may be more common among females with a history of drug addiction than in males, although this finding has not been supported by other researches.

Concluding remarks

Modafinil is a cognitive enhancement drug and is classified as a central nervous system (CNS) stimulant. There is a current debate concerning the use of modafinil as a promising treatment for substance abuse and neurodegenerative disorders.

Only a few solitary, atypical cases of modafinil misuse have been reported. It is rare to experience withdrawal symptoms, but you can experience them if you abuse modafinil for an extended time. Abuse of modafinil may lead to limited psychological dependence.

A modafinil overdose can present unpleasant symptoms like high blood pressure, allergic reactions, and insomnia. However first aid and medical care can help patients to recover.

Modafinil as a Controlled Substance FAQs

Why is Modafinil a Controlled Substance?

Modafinil is a controlled substance because it can be abused. When taken in large doses, modafinil can cause euphoria, increased alertness and energy, and decreased appetite. These effects are similar to those of other stimulants such as amphetamines. Modafinil can also lead to dependence, and people who abuse the drug may experience withdrawal symptoms when they stop taking it.

When Did Modafinil Become a Controlled Substance?

The United States Food and Drug Administration (FDA) has classified modafinil as a controlled substance since October of 2010. This means that it is illegal to sell or distribute without a valid prescription from a licensed healthcare provider. While there are some legitimate uses for modafinil, such as treating narcolepsy, its potential for abuse and dependence make it a risky drug to use without medical supervision.

What Drug Class Is Modafinil (Provigil)?

Modafinil (Provigil) is a Schedule IV drug that belongs to the class of central nervous system (CNS) stimulants.

Is Modafinil (Provigil) a Real Psychostimulant?

Yes, Modafinil (Provigil) is a real psychostimulant. Provigil is used to treat narcolepsy, sleep apnea and shift work sleep disorder. Modafinil increases alertness and wakefulness, improves cognitive function, and reduces fatigue. It is classified as a Schedule IV controlled substance in the US, and as a prescription drug in most other countries.

Is Modafinil The Same As Ritalin?

No, Modafinil is not the same as Ritalin. Modafinil is a Schedule IV medication used to treat narcolepsy while Ritalin is a medication used to treat attention deficit hyperactivity disorder (ADHD). Both medications work by affecting certain chemicals in the brain, but they have different mechanism of action.

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