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Tell the FDA that People with Narcolepsy Need Access to CNS Stimulants

November 19th, 2019

The FDA is seeking public input on the development and evaluation of abuse-deterrent formulations of central nervous system stimulants (CNS). While the intent is to deter abuse, Narcolepsy Network is concerned that the accessibility of CNS stimulants may have a negative impact on people people with narcolepsy, idiopathic hypersomnia, and possibly other rare diseases. The public comment period is an opportunity for you to share these concerns with the FDA before any decisions are made.

We have only seen responsible behavior in regard to stimulant use in our community, and these medications are vitally important to the quality of life for so many people with narcolepsy. We need your help to communicate these concerns to the FDA.

Please copy, paste, modify (indicated in brackets below), and submit the following comment at https://www.regulations.gov/comment?D=FDA-2019-N-3403-0001


Narcolepsy Network is the largest narcolepsy patient advocacy group in the United States, serving tens of thousands of people every year. Narcolepsy Network is dedicated to supporting, connecting, and advocating for people with narcolepsy around the world. Approximately 1 out of every 2,000 people has narcolepsy, and it is estimated that only a quarter of those patients are ever diagnosed. The primary symptom of narcolepsy is excessive daytime sleepiness, and approximately 70% of people with narcolepsy also experience cataplexy (a sudden loss of muscle tone).

We are concerned that there may be unintended consequences in this proposed FDA course of action, that could potentially lead to a crackdown on central nervous system stimulants.

Access to treatment for people with narcolepsy, idiopathic hypersomnia, and other rare diseases may be negatively impacted in the following ways:

  • The use of limited refills or days dispensed or the use of a central pharmacy will add extra burden to people with narcolepsy to obtain their medications.
  • Limiting medications to alternate formulations will increase the cost of treatment, thereby limiting access. 
  • Changing to a new formulation may result in a brand new learning curve for a new drug, which can disrupt an already well-controlled person with narcolepsy’s life.

[If you do not take CNS stimulants.]
Many patients in the narcolepsy community are lawfully prescribed CNS stimulants to manage excessive daytime sleepiness from narcolepsy.

[If you take CNS stimulants.]
I am a patient who is lawfully prescribed CNS stimulants to manage excessive daytime sleepiness from narcolepsy. I do not abuse or misuse stimulants.

[If you do take CNS stimulants, and have been instructed by your prescriber to split them.]
I have been prescribed XXmg of [stimulant name]. Sometimes I will need to take XXmg later in the afternoon. My prescriber has instructed me to split a XXmg pill into halves when this happens.

[If you do take CNS stimulants in staggered doses throughout the day.]
I take [stimulant name] in the morning and afternoon. Staggering the dosing is necessary for me to be functional throughout the entire day. I’m concerned that an Abuse-Deterrent Formulation that targets the oral use of stimulants will interfere with my ability to take multiple doses throughout the day, as I have been directed by my physician to do.

Stimulant abuse or diversion are not reported to occur in narcoleptic patients with a frequency that would lead to clinical concern.*

“Very often a patient with narcolepsy needs several months or even 1 year of experimenting with various doses of various drugs before finding the drug and the dose that works for them.” Turner M. The Treatment of Narcolepsy With Amphetamine-Based Stimulant Medications: A Call for Better Understanding. J Clin Sleep Med. 2019;15(5):803–805. Published 2019 May 15. doi:10.5664/jcsm.7788  


Thank you to Jennifer Schlicht for bringing this to our attention, and for the helpful work of Matthew Cortland at https://www.patreon.com/posts/31604740

More information on the FDA’s Federal Register Notice: https://www.fda.gov/news-events/fda-brief/fda-brief-fda-seeks-input-development-and-evaluation-abuse-deterrent-formulations-central-nervous

Thank you,
Keith Harper
President, Board of Directors
kharper@narcolepsynetwork.org

*Mitler MM, Hajdukovic R, Erman MK. Treatment of narcolepsy with methamphetamine. Sleep. 1993;16(4):306–317

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Date Created: November 19th, 2019
Last Updated: November 19th, 2019

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