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Is Modafinil A Controlled Substance- Legal Status Of Modafinil

Last updated on 22 Jul, 2023

Modafinil is a Schedule IV controlled substance whose legal status varies from country to country.  Schedule IV prescription medication indicates its low risk of abuse and side effects. 

Most people who buy Modafinil online wonder about its legality and if Modafinil is a controlled substance in the USA. If you, too, are planning to get Modafinil 200 mg online without a prescription, then it is advisable to go through this guide before placing an order. 

Modafinil is an effective therapeutic option for treating Excessive daytime sleepiness in people. Its medical use is approved by the FDA, and takes 30 minutes to start acting. 

This comprehensive guide helps you understand the Legal Status Of Modafinil and the rules and regulations for purchasing it online. 

What is Modafinil?

Modafinil is one of the most sought-after and well-known members of the Nootropic family

that cures excessive tiredness or sleepiness, or other sleep disorders. The three basic conditions that are treated by  Modafinil are Narcolepsy, Obstructive Sleep Apnea, and Shift work disorders [1].

It comes under various brand names, such as Modallert. It comes under a class of medications that promotes wakefulness. It was founded back in the year 1974 by two chemists, Gombert and Assous, from L. Lafon Ltd, Paris [2].

Modafinil comes in the tablet form of 100-200mg. The general recommended dose for Modafinil is 200mg/day.

Legal Status of Modafinil

The U.S. Drug Enforcement Administration (DEA) classifies Modafinil as a Schedule IV controlled substance. However,  according to the International Narcotics Control Board, it is not considered a  narcotic or a psychotropic drug. 

Controlled substances are medications or compounds that are strictly regulated by the government due to their higher possibility of addiction or abuse. The production, use, distribution, handling, and storage of such compounds are regulated by the DEA. 

You need a doctor’s prescription to buy Modafinil. 

It’s been above 20 years that Modafinil has been available as a prescription medication in Europe and the USA [4].

The legal status of Modafinil varies according to jurisdiction; in the United States, whereas in the United Kingdom, it is considered a prescription-only medication [5]. 

Modafinil laws and regulations

 In the USA, the FDA has approved the use of Modafinil for medical purposes. The regulations of the Controlled Substance Act of 1970 are listed below.

1. Schedule IV drugs have a low potential for misuse and dependence compared to I, II, and III. Some instances of Schedule IV drugs are Carisoprodol, Diazepam, Midazolam, tramadol, lorazepam, etc.

2. Schedule IV drugs can be prescribed verbally over the phone with a prescription.

3. Refills are permitted for upto 5 times within a period of 6 months from the issue date [7].

Controlled Substances Act And Modafinil Scheduling

The Controlled Substances Act was enacted in the year 1970. The Act establishes 5 schedules under controlled substances, which are laid down as schedules I, II, III, IV, and V.

Modafinil Scheduling as a medication is done under Schedule IV of the Controlled Substances Act. After Scheduling, the amendment is done under sec 811 of the Act [8].

Modafinil Importation Laws And Customs Seizures

Importing medications or drugs that the FDA does not approve into the US is illegal. Modafinil is a controlled substance, and the Drug Enforcement Administration decides whether Controlled Substances can be imported for personal use [9].

Modafinil can be seized under two situations:

  • A shopper may decide to do nothing after the customs notice.  Modafinil will be considered relinquished after 30 days, and it will be destroyed.

  • The receiver of the package might request that Customs and Border Protection (CBP) commences seizure and forfeiture proceedings to allow the owner to engage formally and legally to process the petition for the return of the property [3].

Modafinil Prescription Requirements And Off-Label Use

There are certain prescription requirements for Modafinil. They are listed below
1.  A person should be above 17 years of age.

2. They should have a properly functioning liver and kidney.

3 . The person should not be allergic to Modafinil or any compound in its formulation.

4. Modafinil is not prescribed if a woman is breastfeeding.

5. Modafinil is not allowed if a woman is taking contraceptive pills.

6. Alcohol is strictly prohibited, along with the consumption of Modafinil [11].

Modafinil, along with the treatment of excessive sleepiness, has some off-label benefits. It is used for mood and cognitive enhancement. It also helps in increasing our focus. They are also used for conditions like ADHD, fatigue, depression, etc. However, this should only be used under the suggestions made by your health experts and professionals with proper dosage [12].

The Legal Status Of Modafinil In Different Countries

The legal status of Modafinil is different in different countries. Some of the statuses of different countries are laid down:

Modafinil Legality In The UK

Modafinil in the UK is only prescription limited. It is not listed in the UK in the Misuse of Drugs Act, so its possession is not considered illegal. However, the European Medicines Agency stated that Modafinil should only be limited to treating Narcolepsy. 

Modafinil Legality In Canada

Modafinil is a scheduled F prescription medication in Canada. It is not listed in Controlled Drug and Substances Act. However, it may be subject to seizure by Canada  Border Services Agency if obtained through illegal sources.

Modafinil Legality In Australia

Modafinil is a Schedule 4 medicine in Australia. An individual requires a prescription suggested by specialists to buy the Nootropic [3].

Modafinil Controlled Substance: Conclusion

Modafinil is a controlled substance under Schedule IV drugs, according to the DEA. The legality status of Modafinil differs in different countries. It is therefore recommended to buy Modafinil after consulting a doctor. 


Yes, it is legal to possess Modafinil, but only with a prescription.

Modafinil is classified as a Schedule IV drug.

Modafinil was approved for medical use in the year 1998 in the USA.

It depends upon your health condition whether you require Modafinil or not. If you are suffering from Narcolepsy, Sleep Apnea, or other sleep disorders, you can take modafinil with a prescription as directed by a physician.

Modafinil takes 30-60 minutes to work after it’s taken on a full stomach.


1. Modafinil, Uses, interactions, and side-effects, Cleveland clinic.

2. Modafinil, sciencedirect.

3. Is Modafinil legal? #1 Guide for all countries, Modafinil

4. Is Modafinil legal, Modafinil

5. Modafinil–wikipedia

6. What is Modafinil, drug science

7.  Prescription of Controlled Substances, National Library of  Medicine.

8. US code house (gov).

9. Personal Importation, US Food and Drug.

10. Modafinil: Restrictions on indications and evidence for off-label uses,

11. Modafinil Or al Route, mayo clinic.

12. Exploring The Benefits Of Modafinil Off-Label Use And The Advantages Of Generic Modafinil (Modalert), outlookindia.


Disclaimer: We do not provide any medical advice.

The contents of Healthma are for informational purpose only and is taken by a thorough evaluation of research papers and Journals. We do not provide professional medical advice, treatment, or diagnosis. We advise all readers to consult a physician before consuming any medication mentioned on the website.