Belsomra

[Celexa]

I do mostly inpatient consults but have a small subspecialialzed outpatient practice as part of my faculty position. Prescribed Belsomra (suvorexant) this week for the first time and discovered it's a controlled substance. Why?? Is there actually any abuse potential?

---

Members don't see this ad.

 

[ObsequiousAplomb]

Suvorexant is a dual orexin receptor antagonist approved in the United States and Japan for the treatment of insomnia at a maximum dose of 20 mg. This randomized double-blind crossover study evaluated the abuse potential of suvorexant in 36 healthy recreational polydrug users with a history of sedative and psychedelic drug use. Single doses of suvorexant (40, 80, and 150 mg: 2–7.5 × maximum dose), zolpidem (15 and 30 mg: 1.5–3 × maximum dose), and placebo were administered, with a 10-day washout between treatments. Subjective and objective measures, including visual analog scales (VASs), Addiction Research Center Inventory, and cognitive/psychomotor tests, were evaluated for 24-hour postdose. Suvorexant had significantly greater peak effects on “drug liking” VAS (primary endpoint) than placebo. Although effects of suvorexant on abuse potential measures were generally similar to zolpidem, they remained constant across doses, whereas zolpidem often had greater effects at higher doses. Suvorexant (all doses) had significantly fewer effects than zolpidem 30 mg on secondary measures, such as “high” VAS, Bowdle VAS, and Addiction Research Center Inventory morphine-benzedrine group. The overall incidence of abuse-related adverse events, such as euphoric mood and hallucination, was numerically lower with suvorexant than zolpidem. In agreement with its classification as a schedule IV drug, suvorexant demonstrated abuse potential, compared with placebo. The abuse potential was similar to zolpidem using certain measures, but with a reduced incidence of abuse-related adverse events. Although this suggests that the overall abuse liability of suvorexant may be lower than zolpidem, the actual abuse rates will be assessed with the postmarketing experience.

Assessment of the Abuse Potential of the Orexin Receptor... : Journal of Clinical Psychopharmacology

dative and psychedelic drug use. Single doses of suvorexant (40, 80, and 150 mg: 2–7.5 × maximum dose), zolpidem (15 and 30 mg: 1.5–3 × maximum dose), and placebo were administered, with a 10-day washout between treatments. Subjective and objective measures, including visual analog scales...

journals.lww.com

I was also surprised to learn that when I went to prescribe it for the first time.

 

[Celexa]

Assessment of the Abuse Potential of the Orexin Receptor... : Journal of Clinical Psychopharmacology

dative and psychedelic drug use. Single doses of suvorexant (40, 80, and 150 mg: 2–7.5 × maximum dose), zolpidem (15 and 30 mg: 1.5–3 × maximum dose), and placebo were administered, with a 10-day washout between treatments. Subjective and objective measures, including visual analog scales...

journals.lww.com

I was also surprised to learn that when I went to prescribe it for the first time.

I guess my point is that by that metric, seroquel also should be a controlled substance. So should benadryl. So. Should wellbutrin. If the metric we are using is 'some patients feel a bit altered and like it' there's a LOT of meds that would be controlled but aren't. I guess when a drug is brand new it's fair to say judging the true abuse potential has to happen in post market studies. But once something has been out for a while, is there not any mechanism for reevaluating that? I'm also getting flashbacks to trying to discharge a patient as an intern and learning after my attending had left for the day that vimpat was a controlled substance. Never been able to find a rational reason for that, either...

 

[claypigeon]

Prescribed Belsomra (suvorexant) this week for the first time and discovered it's a controlled substance. Why?? Is there actually any abuse potential?

It’s the same reason marijuana is schedule 1 when most States even say it has a medical use. The same reason 16 years later and 6 years after it was mandated again they never made a special registration for telehealth prescribing of controlled subs. The DEA is a chiefly political, not scientific, organization.

 

[Celexa]

It’s the same reason marijuana is schedule 1 when most States even say it has a medical use. The same reason 16 years later and 6 years after it was mandated again they never made a special registration for telehealth prescribing of controlled subs. The DEA is a chiefly political, not scientific, organization.

But whose politics? Wouldn't it have been in the company's interest for the drug not to be controlled? Was there great outcry by a particular group of the looming dangers of orexin receptor antagonists? Was it sabotage by z-drug companies to keep an easier to prescribe sleep aide off their turf?

Marijuana being scheudle one is very stupid but at least theres a coherent historical explanation, however ill advised.

 

[claypigeon]

But whose politics? Wouldn't it have been in the company's interest for the drug not to be controlled? Was there great outcry by a particular group of the looming dangers of orexin receptor antagonists? Was it sabotage by z-drug companies to keep an easier to prescribe sleep aide off their turf?

Marijuana being scheudle one is very stupid but at least theres a coherent historical explanation, however ill advised.

Sent from my SM-S901U using SDN Forums mobile app

The politics of big government protecting us from ourselves and getting paid to do so.

Page 115 shows data from the RCTs. Instead the DEA relied on a separate study of 36 people with poly substance use disorders where belsomra was associated with a surrogate marker of abuse potential (drug liking on a visual analog scale). If they did that same study with Benadryl or even buspar I bet we’d see the same results.

 

[Sushirolls]

They also have added gabapentin to Prescription Monitoring Database programs.
Because Heroin addicts were tossing into into their viles to potentiate highs...
I have no problem prescribing belsomra and the others to SUD populations, or gabapentin.
Just another symptom of government bureaucracy running amok. Add it to the list.

I wonder if they make an image of Ron Swanson character on flags. Would be great to fly that on my vehicle.

 

[Celexa]

The politics of big government protecting us from ourselves and getting paid to do so.

Page 115 shows data from the RCTs. Instead the DEA relied on a separate study of 36 people with poly substance use disorders where belsomra was associated with a surrogate marker of abuse potential (drug liking on a visual analog scale). If they did that same study with Benadryl or even buspar I bet we’d see the same results.

So it's OK to give a new medication and zolpidem to a group of people with a known history of substance use to see how much they like it? I'd comment more on the ethics of that but I think my brain just melted.

 

[Liquid8]

Never had any concerns with prescribing belsomra - aside that it typically wasn't that effective for insomnia.

Can't really recall anyone wanting more of it or asking to get scripts refilled earlier.

 

[psycho-matic]

I do mostly inpatient consults but have a small subspecialialzed outpatient practice as part of my faculty position. Prescribed Belsomra (suvorexant) this week for the first time and discovered it's a controlled substance. Why?? Is there actually any abuse potential?

The manufacturer of QUVIVIQ, the latest drug in this class, has submitted a request to the DEA to remove DORAs as a controlled substances.

Idorsia Files Petition with the Drug Enforcement Administration (DEA) Urging Them to De-Schedule Dual Orexin Receptor Antagonist Class of Insomnia Medications

/PRNewswire/ -- Yesterday, a Citizen Petition (CP) was filed on behalf of Idorsia Pharmaceuticals (SIX: IDIA), urging the Drug Enforcement Administration (DEA)...

www.prnewswire.com

 

[psycho-matic]

The politics of big government protecting us from ourselves and getting paid to do so.

Page 115 shows data from the RCTs. Instead the DEA relied on a separate study of 36 people with poly substance use disorders where belsomra was associated with a surrogate marker of abuse potential (drug liking on a visual analog scale). If they did that same study with Benadryl or even buspar I bet we’d see the same results.

It's the same reason psychedelics are schedule I even though they've recently been shown to have a lot of benefits for treating PTSD. The government set back promising medical research with psychedelics for decades when it made them illegal in the 1960s, despite their not causing any physiological dependence. Gotta love the war on drugs that will never be won.

 

[psycho-matic]

Never had any concerns with prescribing belsomra - aside that it typically wasn't that effective for insomnia.

Can't really recall anyone wanting more of it or asking to get scripts refilled earlier.

I've seen it work quiet well in elderly patients and it's safety profile makes it desirable for that population. It improves cognition. Doesn't cause respiratory depression. It's actually FDA indicated for dementia and I've seen it work wonders when patients have that diagnosis. Now QUVIVIQ is Belsomra on steroids. I've seen it work when other meds haven't.

 

[ObsequiousAplomb]

It's the same reason psychodelics are schedule I even though they've recently been shown to have a lot of benefit for treating PTSD. The government set back promising medical research with psychodelics for decades when it made them illegal in the 1960s, despite their not causing any physiological dependence. Gotta love the war in drugs that will never be won.

Psych NPs man, can't even spell psychedelic.

 

[ObsequiousAplomb]

I've seen it work quiet well in elderly patients and it's safety profile makes it desirable for that population. It improves cognition. Doesn't cause respiratory depression. It's actually FDA indicated for dementia and I've seen it work wonders when patients have that diagnosis. Now QUVIVIQ is Belsomra on steroids. I've seen it work when other meds haven't.

No it isn't. What makes you think that Belsomra is FDA indicated for dementia? Are you actually a real person or are you just a chatbot?

 

[michaelrack]

No it isn't. What makes you think that Belsomra is FDA indicated for dementia? Are you actually a real person or are you just a chatbot?

The fda has expanded its indication to treatment of insomnia in mild to moderate alzheimer's dementia

 

[psycho-matic]

No it isn't. What makes you think that Belsomra is FDA indicated for dementia? Are you actually a real person or are you just a chatbot?

Lol.

FDA updates insomnia medication info to include Alzheimer’s study

Merck announced that the FDA has updated the prescribing information for suvorexant to include details about an insomnia study in patients with Alzheimer’s.

aasm.org

FDA Approves Expanded Indication for Suvorexant to Treat Insomnia in Alzheimer Disease - Practical Neurology

 

[psycho-matic]

I guess my point is that by that metric, seroquel also should be a controlled substance. So should benadryl. So. Should wellbutrin. If the metric we are using is 'some patients feel a bit altered and like it' there's a LOT of meds that would be controlled but aren't. I guess when a drug is brand new it's fair to say judging the true abuse potential has to happen in post market studies. But once something has been out for a while, is there not any mechanism for reevaluating that? I'm also getting flashbacks to trying to discharge a patient as an intern and learning after my attending had left for the day that vimpat was a controlled substance. Never been able to find a rational reason for that, either...

They don't even give bupropion in jail because people crush and snort it. I agree with you.

 

[psycho-matic]

Psych NPs man, can't even spell psychedelic.

Gotta slow down on the typing after I've taken my Lunesta

 

[Celexa]

The manufacturer of QUVIVIQ, the latest drug in this class, has submitted a request to the DEA to remove DORAs as a controlled substances.

Idorsia Files Petition with the Drug Enforcement Administration (DEA) Urging Them to De-Schedule Dual Orexin Receptor Antagonist Class of Insomnia Medications

/PRNewswire/ -- Yesterday, a Citizen Petition (CP) was filed on behalf of Idorsia Pharmaceuticals (SIX: IDIA), urging the Drug Enforcement Administration (DEA)...

www.prnewswire.com

I honestly wish them the best of luck. I don't see any benefit for this class of medications remaining controlled.

 

[ObsequiousAplomb]

Lol.

FDA updates insomnia medication info to include Alzheimer’s study

Merck announced that the FDA has updated the prescribing information for suvorexant to include details about an insomnia study in patients with Alzheimer’s.

aasm.org

FDA Approves Expanded Indication for Suvorexant to Treat Insomnia in Alzheimer Disease - Practical Neurology

yeah, I wouldn't call insomnia in mild-to-moderate Alzheimer's disease the same thing as dementia, but I guess that's semantics that would be about two or three levels of English above your comprehension, given your bizarre eggcorns in most of your posts. I guess you just love giving pills to all your patients, nurse psycho-matic. god speed with your inevitable realization that you are what is wrong with this country.

 

[psycho-matic]

yeah, I wouldn't call insomnia in mild-to-moderate Alzheimer's disease the same thing as dementia, but I guess that's semantics that would be about two or three levels of English above your comprehension, given your bizarre eggcorns in most of your posts. I guess you just love giving pills to all your patients, nurse psycho-matic. god speed with your inevitable realization that you are what is wrong with this country.

Never said they were the same thing.

I don't push pills to all of my patients. In fact, I often find myself deprescribing. Pills have limitations and I tell patients that. There are some situations where I say meds may or may not help, give them risk vs benefits and the patient makes an informed decision. Sometimes I tell a patient they need therapy instead of medication. When patients come to me with multiple controlled substances., I usually decline to treat them. Recent real life example: Adderall IR, Vyvanse, ambien, clonazepam, diazpepam. Not touching that. You don't know anything about me or my practice, so you shouldn't go around assuming things about me. I'm mainly here to learn. I try to contribute to topics I know things about (I spent the last 3 years in geriatrics under a psychiatrist) but mostly I read these forums to learn. Belsomra has been successful in multiple patients I've had with dementia, including Alzheimer's. No I wasn't specific to Alzheimer's in my initial comment, but I've seen it help with vascular dementia too. It's not a miracle drug but when used with the right patient it's a valuable tool.

 

[clausewitz2]

Let's keep this discussion civil, folks. No need for personal insults.

 

[annoyedpsychiatrist]

Ive used belsomra frequently but the insurance barrier is still a problem many times for me. Quiviq is just belsomra with less daytime sedation but typically at 10mg belsomra doesnt have significant daytime sedation. At 20mg it can help with going to sleep, but carries risk of daytime sedation. Belsomra is mainly used for decreasing WASO (wake after sleep onset) and can lower it by 16-28 minutes in the average person. Ive seen various results with it overall. I think sleep medications as whole are very hit or miss because there are so many factors when it comes to sleep which explains why CBTi is the gold standard.

Belsomra realistically has low abuse potential and is a schedule 4 if i recall. Ive never seen anyone abusing belsomra but its still possible because the higher dose can cause you to be sleepy essentially. Kind of like how seroquel can be abused.