Saturday, February 11, 2012

Piracetam and the FDA

In the past two decades, student abuse of stimulants has nearly tripled, even though scientific studies have shown that they may have damaging effects on a user’s dopamine system. Stimulants produce increased wakefulness and help the user focus. Due to these appealing characteristics, the use of stimulants, specifically Ritalin and Adderall, have become common drugs found in university and professional settings. When prescribed by a psychiatrist, Adderall and Ritalin are used to reduce symptoms associated with attention-deficit hyperactivity disorder (ADHD) and to treat excessive daytime sleepiness in patients with narcolepsy. The drugs not only have the ability to increase energy and focus in ADHD and narcolepsy patients, but students without ADHD or narcolepsy who use stimulants are able to focus their energy and concentrate at a much greater level than normal. Through understanding Adderall and Ritalin’s mechanism of action we can see why it is able to combat both ADHD and narcolepsy, along with why it is widely regarded as a “study drug.” Both of these stimulants work by increasing dopamine levels in the brain—Adderall binds to the dopamine transporter (DAT) inhibiting the reuptake of dopamine and also enters the cell causing an efflux of dopamine to the synaptic space, similarly Ritalin acts as a norepinephrine-dopamine reuptake inhibitor by blocking DAT. Dopamine is known to help decrease “background firing” by increasing the signal to noise ratio in target neurons, which is why neuroscientists believe that Adderall and Ritalin improve attention. However, research has shown that use of stimulants may actually be neurotoxic. One such studied conducted in 1981 at the Karolinska Institutet in Sweden reports that continuous administration of dextro-amphetamine, one of the components of Adderall, led to acute neurodegenerative damage of central dopamine neurons in the caudate nucleus. A more recent study conducted in 2010 at IWK Heath Centre in Canada showed that chronically using Adderall XR at a low dose down-regulates cfos expression in rat striatum and cortex, symbolizing that the neurons have decreased activity.

However a class of drugs known as racetams may be advantageous for students, while not exhibiting neurological damage as seen in the use of stimulants. Unlike stimulants which give the user a sudden burst of energy and an increased ability to concentrate, racetams are considered nootropics—or cognitive enhancers—and increases the user’s cognition, memory, intelligence, motivation, attention, and concentration. The most renowned racetams are piracetam and aniracetam. Unlike stimulants which work primarily on the dopaminergic systems of the brain, piracetam is believed to be a positive allosteric modulator of glutamate via the AMPA receptor and a positive allosteric modulator of acetylcholine via muscarinic cholinergic receptors. Furthermore, it is believed that racetams increase learning and memory due to its interactions with the muscarinic cholinergic receptors and NMDA glutamate receptors, which are both used in the learning and memory process. But not only does it seem to aid the learning and memory process, piracetam has also been shown to improve neuroplasticity, be neuroprotective, and is extremely well tolerated in almost all patients. Due to facilitating neuroplasticity and being neuroprotective in vivo, racetams have been used to slow the progression of Alzheimer’s disease patients. The effects of the racetams clearly present advantages not only to students, but to people with neurological degenerative diseases.

Unfortunately, in 2010 the FDA has revoked piracetam’s classification as a “dietary supplement” and no long can be sold as such. The FDA have clarified that they are not banning piracetam entirely, but many companies that sell or manufacture piracetam have been receiving a lot of grief from the FDA. This is extremely disappointing because many studies have shown that piracetam is safe and actually has cognitive enhancing properties.

Why then are they reclassifying piracetam? In Europe, piracetam is sold as a prescription drug and I can only assume that is what they are trying to do here in the United States. Sure it will take time, but piracetam's reclassification as a prescription drug will be inevitable. I can only wonder why our government is so conservative concerning all types of chemical substances. They are taking a perfectly safe product with cognitive enhancing effects and making it so that it is more expensive, more difficult to obtain, less competition, and more red tape. Then again that’s the American way, right?


  1. I think the topic of neurotrophics is fascinating, especially when compared to stimulants like ritalin and adderall. It seems like neurotrophics are the long-term solution to the issues people use stimulants to temporarily "fix."

    But to be blunt, I sometimes feel that the government doesn't want us to be smarter. The smarter we are, the more questions we raise, and the higher the chance of organized rebellion. I feel the ban against marijuana is rooted in a similar sentiment.

    What will probably happen is they will become expensive and difficult to access, making only the rich and elite able to get their hands on it. They will take it and further enhance themselves, holding out from the middle and lower class so the social stratification in America continues to worsen. And so it goes...

    1. I agree that the government does not want us to be smarter, but I am not sure that this is the main reason for the rescheduling of Piracetam and other nootropics. What I believe is that the government is against anything that may affect our perception. For example, it is quite obvious that weed affects our perception and so do many other drugs that are scheduled, e.g. opiates, hallucinogens, stimulants, etc. The only products that we are allowed to consume in a concentrated form are dietary supplements, i.e. vitamins and other nutrients already found in the foods we commonly eat. While things not commonly found in the foods we eat and that affect our perception are scheduled. The obvious exceptions would be alcohol and caffeine; however, both of these products have seen a vast amount of restrictions and red tape.

      Like you said though, since I have been using the products I have found that finding racetams have became increasingly more difficult. What I have resorted to use is importing racetams from other countries. At the present moment, United States customs are not confiscating racetams or other nootropics. But then again, who knows how long that will last?

    2. Since UK recently deemed Piracetam a prescription-only supplement, FDA took advantage by trying to regulate Piracetam.

      The FDA gains revenue from every single drug they approve. They have special ties with the American Psychological Association (APA). If you think about, the government runs a legal monopoly on psychotic drugs.

      Back on topic... this was all about the money, nothing more.

      ...Apparently, piracetam is now manufactured and FDA approved (at a higher price, of course)

  2. where in this study is written anything about damage to the dopamine system? There is written that amphetamine is even more potent than methylphenidate. Amphetamine gets recommended!

    There are people who need this medication for daily functioning. Not all but there are some. And it helps them to live their live. Being against this medication is in much cases barbarous. Accept this.

  3. What about Ritalin? Inhbiting reuptake is neuroprotective to an extent due to preventing intracellular mao oxidative metabolism and dfferent than a releasing agent.

  4. is an over the counter piracetam-containing nootropic blend. The company is careful not to call it a "supplement" to avoid the ire of the FDA, but you can purchase it without a prescription - it's not a controlled substance at this point.