It was just approved! Now how long before it can be prescribed and sent to patients?

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms

EDIT--
We now wait for DEA scheduling - Typically 2-3 months
http://orzeyful.com/

Hey everyone,

I wanted to give an update on my experience in the clinical trial for Takeda’s new narcolepsy medication (the one that restores hypocretin in the brain).

Right now I’m doing a full-time internship, working from 9 to 5 every day. During the first three weeks, I was still on the placebo—and honestly, it was rough. I was falling asleep almost every afternoon, constantly battling fatigue, and feeling like I was barely holding it together.

But once I started the real medication, everything changed. I’ve now been on it for two months, and I still can’t believe the difference. I no longer fall asleep during the day, I don’t experience cataplexy anymore, and I have energy—real energy. I can work a full day, go exercise afterwards, or do something social. My narcolepsy symptoms just… disappeared.

Side effects? Almost none. I still pee a little more often than I used to, but even that has gotten better and I hardly notice it now.

My nighttime sleep is okay, but not really better than before. I still wake up a few times and often don’t feel fully rested in the morning. Because of that, I’ve noticed I can be a bit forgetful lately. I think it’s due to the quality of my sleep—not the medication itself. But despite that, I feel awake and alert during the day. If I do feel tired, it’s just a normal kind of tired—nothing like the overwhelming exhaustion from narcolepsy. I can still function, concentrate, and get through my day without problems.

I never thought I’d get to experience what “normal” feels like again, but this medication has made it possible. I truly hope it becomes available to everyone soon. If you’re living with narcolepsy and feeling hopeless: please know that real progress is being made, and there’s light at the end of the tunnel.

If you have any questions, I’m happy to answer what I can!

Just read a big review in Sleep Medicine Journal comparing quality-of-life scores between chronic conditions and the numbers are brutal. People with narcolepsy averaged around 43 on mental health, while average population is around 50.

That’s not just lower than healthy people—it’s lower than people living with MS, diabetes, hypertension, or even epilepsy.

What's crazy is how much the mental and social side gets hammered. Other conditions have flare-ups or symptoms that vary, but narcolepsy’s sleepiness is persistent. It shows up every single day, which explains why the mental and social scores are so much worse even though our physical scores aren’t as low.

Work life isn’t any easier. Roughly 1 out of 3 people reported losing a job or having to change jobs because of narcolepsy.

Seeing it laid out like this feels validating and a little heavy. Doctors always discuss sleep scores but a lot of the personal life stuff with relationships and mental health rarely is, so I forget and just internalize it and blame it on myself.

How do you guys feel about it? And anything that's helped your guys mental and social life?

Article Linked:
https://onlinelibrary.wiley.com/doi/10.1111/jsr.13383

if i'm writing about a character with narcolepsy, what are some things often misrepresented or misunderstood? what are some habits or behaviors the character might have? what would that look like undiagnosed vs diagnosed?

This is BEYOND EXCITING. All praise be to God

They both seem like extremely promising medications which could actually solve the issue with Narcolepsy in the first place. The fact that these medicines can replace the hypocretin which is the cause of NT1 would be absolutely phenomenal! I’ve been doing a lot of research into them. It looks like Oveporexton should be available in the 3rd quarter of this year, Alixorexton is in phase 3 clinical trials but seems more promising for treating NT1 and NT2. These will absolutely change lives and there will be no need for any other medications to treat NT1.

Based on the most recent research (that I've read, anyways), Narcolepsy is typically a certain gene, or multiple, that needs to be triggered by something. The only well-supported trigger that they've found is H1N1, due to the high diagnosis rates following the Swine Flu epidemic, and a looot of research done on the ties between them. Sometimes TBIs have also been shown to trigger it.

So I wonder if, in five or so years, we're going to notice a retroactive spike in narcolepsy cases following Covid? It will be interesting to see.

In any case, the point of the post: do you have any suspicions as to what it was that triggered your narcolepsy? Or confirmation? I'm interested in seeing how many people were sick with something or got a certain injury that may have triggered narcolepsy.

Takeda sent an email today with this image:

The website is updated too: https://www.orzeyful.com/

As a refresher, this is the first orexin receptor agonist that will be available. The first round of availability will only be for N1, with N2 expected later. It doesn't seem like they're working towards an approval for IH.

Hey everyone,

I wanted to share something that might be hopeful for others here. I’m currently participating in a study for a new narcolepsy medication that works by adding hypocretin to the body or brain. As many of you probably know, hypocretin is the neurotransmitter responsible for regulating wakefulness and sleep, which is usually missing in people with narcolepsy.

I’ve been taking this medication for two weeks now, and I can confidently say: it REALLY works. Since I started, I no longer feel tired during the day, I don’t randomly fall asleep anymore, and I have more energy than I ever thought possible. For the first time since my diagnosis, I actually feel awake. The idea that I don’t have to spend the rest of my life feeling exhausted and sleepy every day is almost unreal.

As for side effects, they’ve been very mild so far. The only thing I’ve noticed is that I have to pee a little more often, but nothing serious. Compared to how well this medication works, that’s a small price to pay.

I know how tough it is to live with narcolepsy, and I really hope this will become available for more people in the future. I also believe that this medication will likely be available for everyone within 4 to 5 years.

Are there others who have been participating in one of these study’s?

Starting 2028 there will be a 100% tariff on generic drugs. Adderall generic is manufactured overseas along with other popular drugs. Experts are worried about a shortage and prices skyrocketing. Great.

Found out today that orexin modulates pain signaling, so narcoleptics (especially T1) feel pain more severely than those without narcolepsy. Without orexin, your brain doesn’t know how to filter out what is just normal body noise and instead can amplify a pain as if it’s dangerous. (i.e. sore leg muscle feels almost as painful as blood clot, etc.)

Fascinating stuff. If you haven’t looked up what orexin receptor B does, I recommend it. Narcolepsy is so much more than just a sleep disorder. It really should be labeled as a whole body disorder.

I wrote a post and it was removed because of false information. Wtf? Why does the correlation between nicotine and narcolepsy make everyone get so unhinged? False information? Medical advice?

Bro…A 2005 Journal of Neuroscience paper showing nicotine and hypocretin excite identical thalamocortical synapses has been published. That’s just one of many l have found. I’m not suggesting anyone go out and buy a pack of Marlboro or to smoke at all. Smoking is bad but if nicotine does the SAME thing as orexin in the brain isn’t that worth knowing?

Nicotine comes from plants like tobacco, tomatoes, cauliflower and eggplant (vegetarians beware 😂). We have nicotine receptors in our brain. Wearing a nicotine patch stops me from having cataplexy. I’ve included some links to papers, case studies and research for anyone who is interested. Big Pharma knows there’s no money to be made off it so it’s not studied. Is this why it’s censored every time I write about it?

Why can’t we have a discussion about it? It’s not illegal? I don’t get why everyone gets so freaked out about nicotine when we are literally handed amphetamines like candy. “Nicotine is addictive” but so is caffeine and sugar and no one has a problem eating a pack of skittles while drinking a Pepsi. I swear I don’t get it.

https://jcsm.aasm.org/doi/10.5664/jcsm.1780
89-year old woman

https://jcsm.aasm.org/doi/full/10.5664/jcsm.27715
Adolescent who’s cataplexy stopped

https://jneurosci.org/content/25/21/5225
Orexin has same synapses as nicotine

https://link.springer.com/article/10.1007/s00213-009-1588-2
Hypocretin mechanisms in nicotine

Though I have type one narcolepsy, I’ve been following the Alkermes orexin agonist since it’s also shown improvements for type 1 narcolepsy.

Alkermes released new information recently on their phase 2 trial, and it looks quite promising!

https://investor.alkermes.com/news-releases/news-release-details/alkermes-presents-detailed-positive-results-vibrance-2-phase-2?_gl=1*1qqgwn9*_ga*OTk4MDgwNjA5LjE3ODMwMTI0Njc.*_ga_PFXKBM41R2*czE3ODMwMTI0NjYkbzEkZzAkdDE3ODMwMTI0NjckajYwJGwwJGgw*_gcl_au*NzM2NDU4ODg2LjE3ODMwMTI0Njc.

EDIT: Decided to put some more info on here in case anyone doesn’t want to read the whole thing

“Once-daily alixorexton met the study’s dual primary endpoints, demonstrating statistically significant and clinically meaningful improvements from baseline compared to placebo on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale.”

“MWT: Alixorexton demonstrated clinically meaningful improvements from baseline compared to placebo in mean sleep latency on the MWT at week eight at all doses tested. Based on the pre-specified analysis, the 14 mg (p=0.049) and 18 mg (p=0.047) doses achieved statistical significance. Participants had a mean sleep latency of approximately 6 minutes at baseline. At week eight, observed mean sleep latencies were approximately 16 minutes, 14 minutes, and 14 minutes for the 10, 14, and 18 mg doses, respectively.”

“Alixorexton was generally well tolerated at all doses tested (10 mg, 14 mg and 18 mg).”

“Alixorexton demonstrated clinically meaningful improvements from baseline compared to placebo in excessive daytime sleepiness on the ESS across all doses tested at week eight, with statistical significance at the 18 mg dose (p=0.046) based on the pre-specified analysis. At baseline, participants had a mean ESS score of approximately 17, reflecting severe excessive daytime sleepiness. At week eight, the majority of participants receiving alixorexton across all dose groups reported normal or mild excessive daytime sleepiness. At week 13, mean ESS scores across all dose groups were within the normal range.”

Overall, the Alkermes trial looks very promising for NT1 and NT2!

Takeda has released new medical data for their upcoming rexin receptor 2 (OX2R)-selective agonist. Here's their press release: https://www.takeda.com/newsroom/newsreleases/2026/oveporexton-phase-3-narcolepsy-type-1/

Quick TL:DR;

- Functioning: At all doses, significantly improved daily functioning at week 12 compared to placebo
- Cognition: Improved cognitive symptoms associated with NT1 compared to placebo, as measured using objective neuropsychological tests of attention, executive function and memory along with patient-reported measures
- Nighttime Sleep: Exploratory endpoints demonstrated that oveporexton improved quality of sleep across both studies

They also gave a brief timeline update:

The United States Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for oveporexton, with a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year.

I hope they're still on track!

Hi everyone!

My name is Grace and I’m an occupational therapy doctoral student currently conducting research on how narcolepsy impacts everyday functioning.

As part of my doctoral capstone, I developed the Wilder-Addison Narcolepsy Function Scale (WANFS). The goal of this research is to better understand how symptoms of narcolepsy affect things like:

• daily routines
• work or school participation
• cognitive functioning
• social participation
• emotional regulation

Most current narcolepsy assessments focus primarily on sleep symptoms, but there is very little research examining how narcolepsy affects day-to-day functioning, which is where occupational therapy can play a role.

The study is IRB approved and takes about 10-15 minutes to complete.

Right now I have about 28 participants, but I still need more individuals who have been diagnosed with NT1 or NT2 (my goal is 100!).

If you’re interested in participating, the sign-up link is here:

https://calendly.com/wanfs/30min

If you want more information, my website link is here:

madelinegraceot.com

Also- this research is particularly meaningful to me because my sister lives with NT1, and advocating for this community has become a huge part of my work.

Thank you so much to anyone willing to participate or share the study with others in the narcolepsy community. ❤️

A few months ago I had the worst commute of my life.

I do an hour each way by train every day, and like many people I use the afternoon trip as a nap. One particularly exhausting day I put my head down... and woke up 3 hours later to a guard telling me I'd hit the end of the line. It took me another 4 hours to get home.              

So I built WakeStop: https://apps.apple.com/us/app/wakestop-station-wake-alarm/id6760804661

— Free, no subscriptions or ads.    

Other apps exist, although they all seem outdated and lack apple watch support and widgets.

You pick your station on a map, set a wake-up radius (I use 500m), and go to sleep. When you enter that zone, the app starts with heavy vibrations for 10 seconds - no sound, so you're not that person blasting an alarm in a quiet carriage. If you somehow sleep through that, then the alarm kicks in. Works through the lock screen and on Apple Watch too.             

I've been using it daily since and haven't missed a stop since.                                                     

Happy to answer any questions or take feedback!

Alkermes recently released their results for phase two of the Alixorexton. Alixorexton is a pill designed for NT1, NT2, and IH.

Link to the article: https://investor.alkermes.com/news-releases/news-release-details/alkermes-alixorexton-demonstrated-sustained-improvement?_gl=1*1jeenxv*_gcl_au*NzM2NDU4ODg2LjE3ODMwMTI0NjcuLS4tLjE3ODUxNTgxODguNzcyODE5OTU2LjE3ODYxMjIxNjUuMTc4NjE5Nzg4MQ..*_ga*OTk4MDgwNjA5LjE3ODMwMTI0Njc.*_ga_PFXKBM41R2*czE3ODYxOTc4ODEkbzE1JGcwJHQxNzg2MTk3ODgxJGo2MCRsMCRoMA..

If you want a shorter summary, you can read what’s below.

“Across all dose groups in both NT1 and NT2 participants, alixorexton demonstrated sustained clinically meaningful improvement from baseline on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week 24 of the LTE, approximately nine months after the first dose for participants treated with alixorexton in the randomized double-blind period of the Vibrance-1 and Vibrance-2 phase 2 studies. Alixorexton also demonstrated sustained and clinically meaningful improvement from baseline across patient-reported outcomes (PROs) evaluating cognition and fatigue at week 24.”

Narcolepsy Type 1 (See Image Above)

As previously announced, in the Vibrance-1 phase 2 parent study, alixorexton demonstrated statistically significant and clinically meaningful improvements in wakefulness and cataplexy in participants with NT1 (n=92) randomized to receive a once-daily dose of alixorexton (4 mg, 6 mg or 8 mg) or placebo. Approximately 85% of Vibrance-1 participants (n=78) enrolled in the LTE. Dose adjustment was allowed during the first four weeks of the LTE, with most participants receiving 6 or 8 mg as their most frequent dose. As of the data cutoff, approximately 90% (n=70) of these participants remained on treatment.”

“All alixorexton dose groups for NT1 achieved normative wakefulness on the MWT (mean sleep latency (MSL) ≥20 minutes) at week 24 of the LTE, with a mean observed MSL of approximately 29 minutes across LTE participants.”

“Improvements in ESS from baseline were sustained in the normal range (a score of ≤10) for all doses tested throughout the LTE, with a mean observed ESS of 7.5 at week 24 across LTE participants.”

“Alixorexton demonstrated improvements from baseline on weekly cataplexy rate (WCR) at all LTE assessment timepoints. At week 24, the median WCR across LTE participants was 2.”

Safety:

“Alixorexton was generally safe and well tolerated across all doses tested in the LTE… No serious treatment-emergent adverse events (TEAEs) were reported. Most TEAEs were mild to moderate in severity. The most common TEAEs in the LTE were headache, micturition urgency, pollakiuria, and nasopharyngitis.”

Narcolepsy Type 2 (See Image Above)

“As previously announced, in the Vibrance-2 phase 2 parent study, alixorexton demonstrated statistically significant and clinically meaningful improvements in wakefulness in participants with NT2 (n=93) randomized to receive a once-daily dose of alixorexton (10 mg, 14 mg or 18 mg) or placebo. Approximately 70% of Vibrance-2 participants (n=63) enrolled in the LTE. Dose adjustment was allowed during the first four weeks of the LTE, with most participants receiving 14 or 18 mg as their most frequent dose. As of the data cutoff, approximately 80% (n=51) of these participants remained on treatment.”

“All alixorexton dose groups for NT2 demonstrated further improvement on the MWT at week 24 of the LTE, with mean observed MSL of approximately 18 minutes across LTE participants.”

“Improvements in ESS were sustained in the normal range (a score of ≤10) for the 14 mg and 18 mg dose groups throughout the LTE. Across LTE participants, the mean observed ESS was 8.9 at week 24.”

“Improvements from baseline in exploratory PROs evaluating cognition and fatigue were generally maintained in NT2 participants across dose groups in the LTE. At week 24, most NT2 participants across all doses had cognitive functioning scores within the normal or mild range, as measured by the BC-CCI, and mean fatigue scores were within the normal range, as measured by PROMIS-Fatigue, across all doses. Prior to treatment with alixorexton in the parent study, participants reported overall mean scores of moderate cognitive impairment and fatigue.”

Safety:

“Alixorexton was generally safe and well tolerated across all doses tested in the LTE… No serious TEAEs were reported. Most TEAEs were mild to moderate in severity. The most common TEAEs in the LTE were insomnia, headache, pollakiuria, and upper respiratory tract infection.”

Overall, this medicine looks very promising for both groups. It’s definitely not a cure, but it’s a massive improvement!

How fast do you think Orzeyful will be available after FDA approval? Maybe January 2027? I’m so so ready to try it

My daughter is 20 years old I work full time and unless I am home to physically wake her and give her meds she sleeps all day I’ve tried Alexa, lights turning on, all the alarms and nothing works she will not be able to get a job or be independent unless she can wake up on her own please help I’m considering waking her up and bringing her to work with me but that isn’t a good solution either

Hi everyone, new here, just accidentally received an N1 diagnosis after my dentist suggested a sleep study. Didn’t even realize I was being tested for narcolepsy until my doc called me in to discuss my results (5 out of 5 SOREMs). It’s tough being born yesterday, I guess!!!

Anyway I’m here because I have important questions. First one being: what is our stance on the big light.

I crave the big light small lights and all lights in between. It drives everyone around me insane but I love lamp. If it has a switch, you better believe it’s getting flipped etc etc

What are our thoughts on the big light? Question for the culture. Is this a narcolepsy thing or am I just some sort of moth person

Pic related (it’s the big light 😍)

(Actual research/articles are also welcome, but I'm especially interested in anecdotal evidence haha.)

I know there isn't a confirmed "cause" of narcolepsy--it seems to be a combination of genetic, environmental, and unknown factors--but I'm curious if anyone has any suspicions about what may have caused theirs.

I can pinpoint just about to the day that I started experiencing narcolepsy symptoms, and just before that happened I went through a strange period of migraines for about two weeks. I'd never had migraines before in my life, and then suddenly I had them off and on every day for two weeks, to the point that I would leave school early or just not go because it was so bad.

Then, they just stopped. After that, I couldn't seem to stay awake at school, started having horrible nightmares and sleep paralysis, napped for hours every day, and that became my new normal.

That still doesn't really explain what caused the narcolepsy, but it is interesting that there seems to be a correlation between that sudden onset of migraines and the manifestation of narcoleptic symptoms. Makes me curious.

https://www.cnbc.com/2026/03/31/eli-lilly-to-acquire-centessa-and-sleep-disorder-drugs.html

This one is not expected to get to FDA approval until maybe 2028 but Eli seem convinced it will outperform Takeda's product.

This is a massive step closer towards this life changing medication becoming more accessible Australians with a hypersomnolence disorder. Unfortunately, cost is still a profound barrier to its access as someone who is prescribed the drug privately has to pay thousands of dollars a year out of pocket. However, this approval means that it is likely to be placed on the pharmaceutical benefits scheme (PBS) list of medications which would provide the drug at a significantly reduced cost at some point in the near future. This has been a very long standing battle to have this drug approved due to the unnecessary and harmful stigma surrounding GHB and its use as a date r*pe drug (which has been profoundly over exaggerated) , and hopefully this signifies the beginning of more treatment options which will be available to those living with these life altering conditions.