Is Modafinil A Controlled Substance?

Written on December 25, 2022 by | Reviewed by William Gallagher, MNeuroSci

I think it's safe to say that the most controversial Smart Drug on the market is Modafinil.

If you're like me, a Biohacker, you're probably already poppin' Modafinil pills for those late nights.

That being said, one of the questions I hear frequently is about its legal status.

So without further ado, let's just jump straight into it, shall we?

Why Modafinil Is Regulated

To answer the question of whether Modafinil is a controlled/regulated substance or not, the answer is a resounding, unequivocal yes!

It is a controlled substance because of its high potential for abuse (allegedly).

There have been some incredibly knowledgeable, legal-eagle people who have expressed concern that it could be banned by the FDA or DEA.

This is only because there are many legitimate pharmaceuticals in Schedule IV and V that are used everyday to treat serious medical conditions such as ADHD, narcolepsy, ADD, depression and generalized anxiety disorder (to name a few).

If we compare Modafinil to other controlled substances, we can quickly see that Modafinil has;

  • No significant risk of dependence due to its pharmacological effects
  • Accepted current medical use in treatment in United States

According to the FDA's established criteria for scheduling drugs are classified into five distinct categories or schedules based upon:

  • Their known potential for abuse
  • Their currently accepted medical use
  • Resistance to abuse
  • And Scientific evidence of their pharmacological effect or potential for misuse.

As you can see, Modafinil fits the criteria for Schedule IV (a less-restrictive classification than Schedule III and V) specifically in criteria #3. Here is the pertinent text:)

"The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions."

The potential for abuse of Modafinil lies primarily in its ability to improve cognition and perform work from stimulating effects on the CNS, which are not specific to any one disorder.

As such, when taken as prescribed, it should pose little risk of dependence.

With respect to its accepted medical use in treatment in the US, I mentioned above that many drugs are classified as scheduled because they are used improperly by people who do not suffer from their respective disorders (i.e., anabolic steroids).

Modafinil has only one approved indication – excessive daytime sleepiness associated with narcolepsy or other sleep disorders.

In this regard, it falls within a class of drugs that have very limited abuse potential and are used primarily in the treatment of their identified condition.

The DEA regulates drugs if they fall under any one of these five categories:

  • I
  • II
  • III
  • IV
  • Or V

It can be argued that Modafinil does not fall within the strict criteria for inclusion in Schedule IV – which requires a high potential for abuse and no currently accepted medical use in treatment in the United States.

It is important to note that drugs like Adderall are classified as Schedule II because they can be abused with no medical use.