Application Information

This drug has been submitted to the FDA under the reference 018677/001.

Names and composition

"CESAMET" is the commercial name of a drug composed of NABILONE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
018677/001 CESAMET NABILONE CAPSULE/ORAL 1MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
018677/001 CESAMET NABILONE CAPSULE/ORAL 1MG

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Answered questions

My Psychiatrist is talking about puting me on Cesamet?
to deal with nightmares due to post traumatic stress Syndrome due to a botched cancer operation about 4 years ago where I mistakenly told I had terminal cancer.I am doing fine now physically a wreck as you may imagine , my story is long and detailed and I won't bore you with it other to say I have vivid... Asked by Delila Teplica 1 year ago.

to deal with nightmares due to post traumatic stress Syndrome due to a botched cancer operation about 4 years ago where I mistakenly told I had terminal cancer.I am doing fine now physically a wreck as you may imagine , my story is long and detailed and I won't bore you with it other to say I have vivid horrible nightmares every night and we have tried other pharmaceuticals to no avail , according to a Canadian study Nabilone (Cesamet) is synthetic marijuana which is taken orally, controls 72 % of PTSD patients nightmares.Here is my question , i also take from the same Dr, a heavy dose of antidepressants , and a large dose of valium and ativan (I am a retired pharmacist but have never dealt with Cesamet ....my question is , On the meds I'm on know I can drive during the day to drop my boys off at school and go about my daily business If I take the Cesamet at night.....will Cesamet will stop me from driving all together i'm afra it'[s a no go Answered by Arnetta Maturi 1 year ago.

Maybe run all this by the pharmacist. They take more training in medications plus interactions than do doctors. I would be wary of driving in those conditions (the amount and various medications). Answered by Raina Shield 1 year ago.


Is the drug NABILONE legal in the US.?
Asked by Jeffry Gillstrap 1 year ago.

Yes, it's sold under the name Cesamet, and has a properly listed NDA, and is sold in 1 mg pills. It's generally regarded as a 4th or 5th line antiemetic drug for chemotherapy. Answered by Kyla Vanderveer 1 year ago.


Why is Cannabis/Weed/Marijuana Illegal?
I know there's going to be a lot of people just saying something like, "cus its a drug; its dangerous and addictive" and that is completely wrong and is a common misconception caused by what we are all raised to believe.Firstly it is not dangerous at all; it is impossible to overdose on this drug,... Asked by Alex Dinwiddie 1 year ago.

I know there's going to be a lot of people just saying something like, "cus its a drug; its dangerous and addictive" and that is completely wrong and is a common misconception caused by what we are all raised to believe. Firstly it is not dangerous at all; it is impossible to overdose on this drug, you would have to smoke about a third of your body weight in 15 minutes which is not only not enough time to smoke that quantity, but you would also be throwing up and passing out before you even reach 1% of your body weight. Even the long term affects of this drug are not that bad; when you compare it to tobacco, tobacco is more harmful to your health. Secondly it is not really physically addictive. You'd have to smoke a hell of a lot on a regular basis to get addicted, and even then the withdrawal symptoms aren't that bad. However you can become mentally addicted to the feeling that it gives you, but this is also true with anything from TV to eating chocolate. I just don't understand why this drug is a class B drug when alcohol and tobacco are legal when tobacco is both more addictive and dangerous and alcohol is more intoxicating and dangerous. Answered by Katrina Decourcey 1 year ago.

The current reason marijuana remains illegal is that most countries make any drug that is known to be addictive and that has not been shown to have a legitimate medical use illegal. Although marijuana is likely helpful for a number of conditions at the moment there is very little evidence to back that up. Prescription medications like Sativex (delta-9-tetrahydrocannabinol/cannabidio... Cesamet (nabilone), and Marinol (dronabinol) have been shown to be effective for a number of medical problems. The reason alcohol and tobacco are legal is only because they are part of the culture and can’t really be gotten rid of. Although marijuana has been found to be safer than alcohol or tobacco its use is NOT socially acceptable for the most part. Also drinking a small amount of alcohol is not harmful and in some cases has established health benefits. There is also so much misinformation about marijuana so many people have based their opinion on faulty information and a generalized fear of "drugs." It would also be hard for a politician to make marijuana legal without potentially destroying his political career. To clarify about "physical addiction" and "psychological addiction" there is no such thing as physical addiction. Physical dependence (the correct term) is not related to addiction except for the fact that many addicts are physically dependent (if the drug they use can cause physical dependence) yet if a person is only physically dependent (and not psychologically dependent) they are NOT an addict. Addiction is defined as a primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviours that include the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. On the other hand physical dependence is defined as a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Addiction has to do with harm, if a person is using a drug (any drug, in any amount, for any length of time) and their drug use does not cause harm they are not an addict. And if a person is physically dependent to a drug they take for a medical reason they are not addicted. Although marijuana does not have physical withdrawal symptoms does not really mean anything. Withdrawal occurs if a person is physically dependent which, as I said, is separate issue from addiction. It is certainly true that when it comes to marijuana being legal or illegal the issues are very complex. But saying that marijuana should be legal because it is less bad than alcohol or tobacco is not enough of an argument. Answered by Donetta Lairson 1 year ago.

i am going to correct you on a few things but i agree that it is illegal for stupid reasons. it really should be legalized i heard dr drew (who is an awesome addiction medicine specialist on the radio 10-12 pm pacific sunday through thursday) say that there is no such thing as physical or mental addiction, there is only addiction. you can either stop something or you cant. you may have physical or mental withdraw symptoms, but withdraw symptoms do not determine the kind of addictive qualities something has. im not trying to say you are wrong, im just saying that it is something a lot of people have a bit of misinformation about he also said that the hardest thing for people to stop using is weed. he says that he can clean a heroin addict up, he can clean a meth addict up, but a marijuana addict is hard to clean up. and he says its possible that the feeling they get from the weed is what is keeping them hooked. while it is true that there are no physical symptoms of withdraw, there are mental symptoms of withdraw like severe anxiety, depression, and sometimes suicidal thoughts so any heavy heavy smoker who wants to stop using weed needs to keep in contact with a doctor so they dont end up killing themselves and so they can actually stop using it heavily. that being said, its a total bullshit legal thing and it really shouldnt be illegal. i think everyone over 18 should be allowed to smoke it however much they want. its not illegal to drink and more people have been killed by alcohol related deaths than weed related deaths. smoking cigarettes causes thousands every year to die while the act of smoking marijuana isnt good for your lungs, there are other ways to get the thc like vaporizing. vaporizing doesnt create the smoke that is bad for your lungs. people who say smoking marijuana is harmless are also wrong. smoking it releases carcinogens into your lungs. but that shouldnt be illegal either. the whole pot being illegal is only giving money to the mexican drug cartels. think about it this way, if there was a legit business that sold weed, would you buy from some shady looking SOB in an alley or from the legit company? if the government put heavy regulations on weed (potency restrictions, purity restrictions, age restrictions, ect.) then it could actually be a legitimate business and consenting adults would be able to purchase weed, pay a tax on it, and smoke it. the tax would help the state and the people would be happy. Answered by Merlyn Manocchio 1 year ago.

First off, it IS less harmful than alcohol. Much. I need to make that perfectly clear. Alcoholism affects millions of Americans/Canadians...very, very few people can actually be considered a marijuana "addict", or even at risk of withdrawal symptoms. Also, since you can OD on booze but not weed, I think that speaks for itself. Thousands die every year from alcohol-related car accidents; if you're high enough on weed that it would affect your driving...you'd be too lazy to drive at that point anyway. Now that I got that out of the way, there are a few reasons why it's illegal. It originated with racism...back in the 20's, marijuana was associated with hispanics and blacks (for some reason). The government wanted A) another reason to arrest them, and B) to stop their culture from spreading into the "pure" white culture. Conservatives continued to push the whole scare factor to this end, and what we got was Reefer Madness...a great deal of the country still remains in this frame of mind. Also, weed in the 60's was associated with defiance and rebelliousness, especially against the Vietnam War...something that Nixon hated, which led him to pass more anti-weed legislature. Right now a big reason is big pharmaceutical companies, which have many politicians on their payroll, don't want people potentially getting a cheaper, natural medicine which might create competition. In today's world, it also stays illegal because people are simply afraid to speak out about it, for fear of being labelled a druggie or the like. Answered by Alan Gernatt 1 year ago.

It became illegal because of the 'paper lobby', since it's an incredibly versatile plant of course, hemp products are great, and it posed a threat to a lot of industries, including the paper lobby, who had a solid lobby, to get it declared illegal. Your risk assessment is a little miss-informed, it's slightly more risky than alcohol(more addictive, and the risks are slightly higher), but not enough to warrant it being illegal. It should be made legal though, over here in Holland, and in Scandinavia(Norway, Sweden, Finland, Denmark), they researched it, and legalizing wouldn't increase the risks to public health(legal, or illegal, the problematic-user numbers pretty much stay the same), and it would reduce drug-crime by at lot(up to 40%), so there's no realistic reason, to keep it illegal. It's all just politics. Answered by Aretha Magro 1 year ago.

I support not putting people in jail for it.I support it more than drunkeness in public.I agree its a must for medical porpose I think its questionable who really needs to be medically percribed.I mean most the time doctors only know what you tell them mentally and somtimes medically.I dont condone weed in the hands of kids and dont like easy access to it when parents are negletful.If its used in public im concerned for second hand smoke with babys.But if used in your home under adults no kids exposure nothing is wrong with it.I do belive however that goverment will find a way to bleed pot smokers dry in taxes and cost.And that would be unfair to potheads but got to pay to play after all booze anit cheap eathier.So when you weigh the good and bad good prevails.Im a juvinille detention defence lawyer and I hate to see a kid whos 13 smoking and doing stupid stuff behind weed but If your grown and pay your own way in life do what you want. Answered by Liane Hoppman 1 year ago.

I believe that marijuana should be made legal with the same restrictions as alcohol (no driving, cant be under the influence in a public place). I dont know why they dont legalize it, It is already one of the highest selling crop in the states, it could potentially help gradually pull the states out of debt. Answered by Ligia Koiner 1 year ago.

Its illegal because there is no way to test your levels - they cant place any legal regulations because if you drive high it doesnt show up in your blood, breathalizer (sp?) or urine. nobody can know your levels. maybe its similar to alcohol, or even less effective/toxic, but alcohol levels can be tested and regulated. (and tobacco doesnt cloud your judgement or reflexes either) Answered by Blanche Salzberg 1 year ago.

I agree. Its no more harmful than cigarettes and alcohol. I dont even smoke weed, but I do smoke cigs and drink and I can tell ya its way worse. Make it legal! Answered by Leonie Franzi 1 year ago.

Move to Holland. Answered by Stephane Reddekopp 1 year ago.


Would you take all these at once?
went to the doctor yesterday because I have narrowing of the spine, as well as generalized anxeity and PTSD. She put me on 50 mg of zoloft 1x a day, 7.5/325 Norco 3x a day (similar to vicodin) .5mgs twice daily of xanax, along with neurontin and motrin 800. My doctor is really nice and compassionate, I just... Asked by Kimberly Kirley 1 year ago.

went to the doctor yesterday because I have narrowing of the spine, as well as generalized anxeity and PTSD. She put me on 50 mg of zoloft 1x a day, 7.5/325 Norco 3x a day (similar to vicodin) .5mgs twice daily of xanax, along with neurontin and motrin 800. My doctor is really nice and compassionate, I just don't want to " wake up dead" one morning, I'm not even 30, and yes I do have legit issues, but do you think I am being over medicated? Thank you for your help. Answered by Brigid Despres 1 year ago.

As long as each drug isn't being duplicated. 1. Narcotic for Pain (norco) 2. Anti Anxiety Pill (xanax) 3. Anti Depressant (zoloft) 4. Anti Inflammatory (motrin) 5. Anti Epilesy (neurontin) If you aren't working you may want to see what you doctor feels about the chronic pain protocol. 1. Fentynal .25 mg every 48-72 hours 2. Cesamet 6 mg per day spread out 3. Noritryptaline 100mg/bedtime 4. Welbutrin 150SR/bedtime What happens when you're suffering, is that you bring you symptoms to the doctor and they prescribe the symptom forgetting the big picture. You're wise to ask because it's not necessary to be on duplicate drugs doing duplicate things. Make sure your doctor is always aware of ALL your drugs sitting on your shelf to be used when you feel like it. Pain medication has to be taken on a schedule and not stopped. So, you don't pop a vicodan or norco when you have pain, you take it every 4 hours as directed and you should never experience pain. You have to do it this way or your body will never stabilize on it and you risk being dopey and drugged around family and friends. Whereas when you keep it in your system, you are yourself. I'm a decade older suffering from PTSD, Anklosing Spondylitis, & IBS. Hopefully, you'll be able to take a few weeks off work to adjust your meds properly. It's a process. I DON'T think you are over medicated, but your doctor should be able to cut out the Motrin and Nuerontin (does it really help you?). I find Gabapenten/Nuerontin as a waste of time, doper, weight gainer, but it could be different for you. I asked to be sent to a psychiatrist at this point where I was still experiencng pain and I had a list of drugs doing a bunch of different things and I was soooo scared I wouldn't wake up. Meds are their specialty, and they have a better understanding of ptsd, anxiety, panic, and clinical depression. Answered by Johna Schmitke 1 year ago.

I'd take the zoloft and neurontin as prescribed then start taking the other 3 once a day and see how I feel. If once a day works for the pain and anxiety then you wont have to take all those pills. The other 3 pills are also addicting so the less of those you can get by with taking the better off you'll be. Answered by Jayne Haleamau 1 year ago.


Need help with Medical Marijuana card!?
Hi, I've recently asked my mom if I could get a medical marijuana card, but she has dubious feelings about Medical Marijuana. I need help with information that is unbiased, correct information, and information that has scientific evidence and a reliable source of information. My mom feels doubtful of Marijuana... Asked by Scarlet Strople 1 year ago.

Hi, I've recently asked my mom if I could get a medical marijuana card, but she has dubious feelings about Medical Marijuana. I need help with information that is unbiased, correct information, and information that has scientific evidence and a reliable source of information. My mom feels doubtful of Marijuana because it's illegal and it is considered a drug. She wants to know why it's banned in other states and why California was one of the states to legalize Medical Marijuana and what medical marijuana does to you in the long-term effects. (Please don't give me government websites about Marijuana or etc that has biased,misleading information, or over exaggerated information) My age shouldn't concern you and no, I am not planning to use it for recreational uses or for any illegal uses. I am planning to use this solely to treat my qualifying conditions I've been suffering with for many years. Additional Notes: Please give me websites leading to the correct information about Marijuana's effects, why it's seen as a bad drug, and why California was the first to accept the usage of Marijuana for medical purposes while other states in the U.S. completely denied marijuana. Answered by Clora Arking 1 year ago.

The US Controlled Substances Act (CSA) of 1990 classifies marijuana as a Schedule I substance, which has no approved medical use and has high potential for abuse. However, many US states have legalized the use of medical marijuana. Prescription medicines containing synthetic cannabinoids (THC) are already available. ------ Marinol (dronabinol) - Classified as Schedule III ------ Cesamet (nabilone) - Classified as Schedule II Both medications are used to treat chemotherapy patients who have nausea, vomiting and loss of appetite. However, Marinol is also approved to treat HIV patients with cachexia (weight loss, muscle atrophy, fatigue and loss of appetite). Studies have also been done which show that THC and cannabidiol (CBD) provide therapeutic benefit for Multiple Sclerosis (MS) spasticity symptoms.3 In Canada, Europe, the UK, Spain, Germany, Denmark, the Czech Republic, Sweden, and New Zealand, Sativex, an oral sublingual spray, is available for adjunctive use in MS neuropathic pain and cancer-related pain. Sativex® is composed of plant-derived extracts of THC and cannabidiol, not synthetic cannabinoids. In 2013, Sativex was in Phase II and III clinical trials for US approval for use in MS spasticity and cancer pain, and has the adopted generic name of nabiximols. Dronabinol has also been used in Europe for treatment of MS-related pain. Marijuana has also been used for glaucoma to lower intraocular pressure (IOP), but research does not show that marijuana has a better effect than currently approved glaucoma medications. Studies have shown that smoked, oral or IV use may have an effect on lowering IOP, but topically applied marijuana derivatives to the eye did not have an effect. Marijuana is not FDA approved for use in glaucoma, and may lead to other side effects such as increased heart rate and lowered blood pressure. However, in some US states, marijuana is used for glaucoma under medical marijuana programs. Answered by Rea Traweek 1 year ago.

If you are an adult your mother can not stop you If you live in a state where its legal and have a genuine medical condition go and see your doctor If you are not an adult stop trying to self medicate and see a REAL doctor. Answered by Moriah Vandeman 1 year ago.


Smoking weed good or bad?
No stupid answers. And i mean medical reasons why it’s worse that cigarettes. Asked by Burton Lehr 1 year ago.

I'd say cigarettes are worse also: 1. Nasty chemicals in there 2. they're addictive! yeah, marijuana can be addictive too, but only in the way food or sex or gambling, etc. can be addictive--you really like it so you tend to crave it psychologically. cigarettes are physically addictive which is why you experience withdrawal symptoms when you quit; much harder habit to break. plus, you end up smoking much less weed than you do cigarettes because of this; it's much easier to moderate your consumption. I've never heard that marijuana kills brain cells other than in unsubstantiated alarmist literature. It's definitely not good for you to inhale smoke into your lungs, though. Marijuana does contain a lot more tar and other natural chemicals than cigarettes that are harmful. There are devices you can buy that will vaporize the THC in marijuana without "burning" the rest of the plant, so you get all the benefits without the nasty smoke inhalation--look into it if you're interested. Answered by Johnny Swindell 1 year ago.

Is Weed Good Or Bad Answered by Marketta Liszewski 1 year ago.

I smoke both cigarettes and weed, so I can answer your question. Smoking cigarettes is worse then smoking weed for the following reasons. Cigarettes contain nicotine, which is one of the most habit forming drugs in the world. Smoking cigarettes is an expensive habit to form. I spend roughly around 300 dollars every month on smokes. So that means I spend $3,600 on cigarettes. I only spend about 300-400 on pot a year. I can stop smoking weed anytime I want with no withdrawal symptoms, but I can not stop smoking cigarettes, I have actually tried to quite 6 times and still smoke. Cigarette cravings go on for hours. When I smoked pot, I never had a smokers cough, but now that I smoke cigarettes, I have a bad cough that never goes away. Imagine waking up in middle of the night coughing your lungs out for a half hour. Its very painful and as long as I still keep smoking cigarettes, the cough will never go away. Even when I'm coughing I will still want to smoke a cigarette. Cigarettes also causes lung cancer, tooth decay, teeth to become yellow, mouth cancer, throat cancer, heart disease, and many other respiratory diseases. Thousands of people die from smoking and that's a proven fact. Nobody ever dies from smoking pot, also nobody has ever overdose from smoking weed. Weed is also natural and cigarettes contain over 3,000 harmful chemicals. It is true that cigarettes have more tar; however, when you do the math, its really not more tar. Cigarettes I smoke per month/Year. 1120/13340 Pot I smoke per year. 60/720 A joint is equal to 20 cigarettes, and I smoke only 3 joints a month. As you can see, cigarettes are more harmful and in the long term contain more tar. I wish I never started smoking cigarettes. I also have shortness of breath due to cigarette smoking, never had that with pot. If you use a vaporizer, then pot isn't even bad for your lungs at all. It hits the THC into vapor and you suck air, so no smoke at all, perfectly healthy. You can also develop mouth cancer from chewing tobacco in as little as five years, then you have to have part of your jaw or tongue removed if you want to live, doesn't sound like fun to me. The real reason weed is illegal is because the government can't tax it, people would just grow it on their own and its not hard to grow. Answered by Chastity Needle 1 year ago.

This Site Might Help You. RE: Smoking weed good or bad? So i've heard that smoking weed is really bad for you, like five times worse than cigarettes. But all my friends keep insisting that its not worse that cigarettes and is actually better for you. So the questions is: is weed really that bad for you or is it better for you that cigarettes? Answered by Deangelo Bongard 1 year ago.

Is Weed Bad For You Answered by Miriam Level 1 year ago.

In my opinion its bad. Ive been around a few people that have smoked it and to bo honest from having a smoke every friday night eventually led to most of them smoking it daily and making a lifestyle choice out of it. And it is worse for you than cigarettes, it causes paranoia which cigarettes do not, i actually had an ex boyfriend who got violent everytime he smoked this stuff because he got that paranoid he thought everyone was against him. It also causes people to be unable to function properly whereas smoking can have the same effect on people but for example they can still drive a car whereas by under the influence of drugs you can not (well you can but dangerously). anything that has the ability to mess with your brain like that is not good for you and eventually will effect you for the rest of your life with mental disorders, smoking may cause cancer but then again so does smoking weed cause you have to put a ciggerette with it anyway most of the time or it won't smoke. Answered by Marguerita Au 1 year ago.

Well, it is worse. Any kind of smoking CAN causes lung cancer, but some people don't catch it, but it's a very high risk.And most likely, smoking weed makes the risk higher. Answered by Gisela Delgreco 1 year ago.

All Praise Pizza! Acutally it is bad to smoke weed, because it can affect how people are thinking, they might tell that it help them to focus but it is only their view of point. FAct they will behave strange. Plus smoking weed can give you lung cancer like cigarettes so weed is worst ALl Praise Pizza! Answered by Helaine Yenor 1 year ago.

The best thing to do is research your question as much as possible using as much information as there is available, then make your own decision... ...There will be many people answering your question on here who will be convinced they know how to answer it, but in my opinion nobody can answer it with any degree of certainty. From the research that i've done on the subject Cannabis effects short-term and long-term are dependent on many factors e.g. strain of cannabis used, method of intake, amount of usage, age of user, addictive tendencies etc. These factors effect the credibility of any studies suggesting the negative impact of Cannabis. In my opinion, studies on the potential benefits of Cannabis use for certain medical problems are more credible. Whereas studies linking Cannabis usage to causing mental and/or physical problems seem to fall short in proving causality, so those who are quick to say it's bad for you etc. should really research before they comment in order to have an informed opinion rather than just a personal one. In an attempt to give a more specific answer to your question on whether or not weed is better for you than cigarettes....i believe that with using vaporizers, the inhaling of a vapor as opposed to smoke caused by burning is a healthy alternative. Cannabis has been used in cultures for over 10,000 years. ZERO reports of a death caused by Cannabis. ZERO reports of an overdose caused by Cannabis. William Randolph Hearst aided the anti-marijuana movement back in the early 1930's and if you take a look into the reasons why, it may provide an insight into the beginning of negative propaganda surrounding Cannabis and it's credibility. :-) Regards, Matt. Answered by Carmina Pellerito 1 year ago.


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