Is Modafinil A Controlled Substance?

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 it's legal status.

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

Modafinil and its high potential for abuse

To answer the question of whether Modafinil is a controlled 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).

So how does Modafinil fare?

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.

The Legality of Modafinil

In addition to its marked pharmacological effects, Modafinil has been approved by the FDA for the treatment of excessive daytime sleepiness associated with narcolepsy and other sleep disorders.

Modafinil is made by Cephalon Inc and is considered one of the most popular "smart drugs" on the market. It is classified as a Schedule IV controlled substance, yet it remains in a gray area in most countries and is even legal in some countries including Russia, Germany, India, and China.

This raises some interesting possibilities for its legal status in various countries.

For example in Russia where Modafinil has been recently banned – why? What's wrong with it? There are no health concerns with Modafinil that would justify a ban unlike for example with Anabolic steroids which were regulated because of health risks related to abuse of these substances – negative effects such as damage to liver or kidneys (not proven to be the case for modafinil).

In fact in many countries Modafinil is still legal and is still being used by millions of people without any significant issues.

Thus, if we consider the overall scope and context of medical conditions for which the drug is used, we can see that there are many illegal substances that are far more dangerous than Modafinil.

Modafinil seems to be quite controversial among people who use smart drugs – probably because of its marketing by various pharmaceutical companies like Cephalon Inc., a company which is known to be prominently involved in aggressive direct-to-consumer advertising campaigns using celebrity endorsements.

The Safety and Benefits of Modafinil

It is unclear whether Modafinil is actually safe and effective for common medical conditions.

There are no studies or research which would establish this and it seems that there is not even a consensus among doctors as to what benefits a person who takes Modafinil could expect from it.

In the end, it seems that the benefits that individuals can expect to receive from Modafinil are not really clear and this is likely due to the lack of research on this drug.

Nevertheless, based on what I could find on the internet, here's what we know about the benefits of Modafinil thus far:

More Alert

It is generally recognized among users as being a powerful drug when it comes to increasing energy and alertness.

After taking Modafinil for periods ranging from a few hours to a few days at a time, people generally report feeling more alert, having less difficulty sleeping, and being able to think clearly about problems that might have been bothering them before.

This is what most people who take Modafinil are looking for – better mental clarity. But there are some others out there who would like for their moods and feelings to change as well.

Many people seem to use modafinil as an alternative or supplementary treatment for depression or other mood disorders.

People who experience lower levels of "happiness" naturally may find that they can use Modafinil to boost their mood.

Can be considered as a second-line treatment option for depression

Another use of Modafinil is the treatment of chronic fatigue syndrome. From my research, I've gathered that Modafinil is sometimes used by chronic fatigue patients to improve energy levels and improve their overall physical functioning.

This is an example of a condition where Modafinil could be useful – chronic fatigue syndrome (CFS).

However, there are many people who find it ineffective for this condition and prefer other drugs such as antidepressants or neuroleptics.

Weight Loss

Modafinil is also used by people who want to lose weight. Some users claim that they find the drug effective in controlling weight gain and increasing energy levels.

In some cases, people take Modafinil as a "lifestyle" medicine – for example, to help them stay awake during a very busy and stressful week, or for an exam, or for any other important occasion in their lives.

People who are trying to lose weight may find modafinil effective in their program. People who have sleep issues may also find this drug helpful in controlling their appetite and helping them build self-discipline and willpower when it comes to dieting.

It may be considered as a complementary treatment for diet control – along with proper nutrition and exercise (when needed). Saying "complementary treatment" is actually saying that it's a second-line treatment – its role is not essential but it can provide support.

Lastly, Modafinil users also claim that the drug is useful for treating neurodegenerative diseases such as Parkinson's, Alzheimer's, multiple sclerosis and Lou Gehrig's disease.