Melatonin Drug moved to Schedule 4?

[joelus]

More visits to doctors, dispensing fees for pharmacists and of course creating the opportunity to divert money to their friends at the pharmaceutical companies. Can't have people having access to effective sleep aids over the counter when there are patented medicines to sell. Given their history I'll assume the MCC is guilty until proven innocent.


My god with those incredibly serious side effects as justification maybe we should make coffee schedule 4 too. In fact let's make everything prescription only.

Getting pregnant when you're not in a position to look after and raise a child is not a joke.
I mean goodness, it's not like it's now impossible to get. You go to a doctor and get a prescription.
Research continues, so saying things like we might never know the long term effects is silly. The MCC is following strict guidelines here and although it may not be scheduled everywhere it is agreed everywhere that you should talk to a doctor first and that the long term effects are unknown.

The findings of this review suggest that exogenous melatonin is a relatively safe substance when used in the short term, over a period of days or weeks, and is safe at relatively high doses and in various formulations. However, the safety of exogenous melatonin when used in the long-term, over months and years, remains unclear.

Conclusions
Evidence suggests that melatonin is not effective in treating most primary sleep disorders with short-term use, although there is some evidence to suggest that melatonin is effective in treating delayed sleep phase syndrome with short-term use.
Evidence suggests that melatonin is not effective in treating most secondary sleep disorders with short-term use.
No evidence suggests that melatonin is effective in alleviating the sleep disturbance aspect of jet lag and shiftwork disorder.
Evidence suggests that melatonin is safe with short-term use.
Evidence suggests that exogenous melatonin has a short half-life and it penetrates the blood-brain-barrier.
Evidence suggests a link between endogenous melatonin and the sleep cycle.
Evidence suggests a link between endogenous melatonin and the temperature rhythm.

http://www.ahrq.gov/clinic/epcsums/melatsum.htm

Melatonin has gained in popularity as a sleep aid, especially for lessening the effects of jet lag. Unfortunately, the long-term effects of this naturally-occurring amino acid are unknown for humans, and many doctors warn against its continual use. However, initial research using lower mammals has promise for long-term human consumption. It is highly recommended to discuss the use of melatonin with a health care provider, especially because melatonin is not regulated by the FDA and commercial supplements may differ in regards to quality and purity.

http://www.livestrong.com/article/11...#ixzz1vscN2KUJ

[Ockie]

When I bought my last bottle I also could not find it at the normal place in Dischem. The lady told me it was moved behind the counter cause it is now on schedule 2 (not 4 as per this thread...maybe it has changed again). The lady behind the counter just handed it over though. No questions.

I take it cause many nights I have trouble falling asleep. Tossing (no funny remarks please ) and turning for hours. When I take Melatonin i tend to fall asleep a lot faster. Considering that it has a very short half life and does not stay in your system for long and it acts a one of the most potent anti oxidants you can find I really dont undertand what the big deal is?

[Garyvdh]

Ja no... it has definitely been moved to Schedule 4... you can see the Government Gazette here...

Melatonin. when used for the amelioration of desyncronosis (iet-laq) in doses not exceedino 6mo daily_ (54).

http://www.greengazette.co.za/docume...-GGR-35149.pdf

and here...

http://www.mccza.com/genericDocument...s_Jul10_v1.doc

The reasoning behind the move has to do with Melatonin's Neural Effects. Or so that rationale goes.

If it was a financially motivated move, then it was rather to force people to buy other forms of sleep medication.
But I think that is probably conspiracy theory and unlikely.

[Moklet Kcuf]

Can't see why it was scheduled, one could have the same effect eating a sugar pill.
From my experience and from what I've heard off others close to me, it has a negligible effect helping one to have a reliably decent sleep.

[joelus]

Can't see why it was scheduled, one could have the same effect eating a sugar pill.
From my experience and from what I've heard off others close to me, it has a negligible effect helping one to have a reliably decent sleep.

Unfortunately your experience and hearsay doesn't constitute scientific research. It's scheduled because research into long term use has not been done and the consequences of long term use are thus not known.

[RiaX]

The MCC know more than you people. There is potential abuse with melatonin since it can cause vivid dreams. Its also been scheduled for its class which is hormones (S3 S4). Also keep in mind there are a lot of systems in play with deciding how the formulation interacts with the body. Its not simply wikipedia and google that will give you the full picture, pharmacodynamics and pharmacokinects are equally important and how it interacts with the body on a receptor level. Melatonin introduced synthetically will interfere with cardiac rythm, thats how it causes drowsiness. Though the dangerous thing about this it will disrupt what is known as a negative feedback cycle. Your body will stop producing its own melatonin with chronic use of the stuff, hence why its acceptable for an acute burst. In the long run, it will make your insomnia worse.

The biggest problem with insomnia is the diet, caffiene, sugar and incorrect energy intake and incorrect periods. Try eating the smallest meal for supper in the day with less carbohydrates, you will feel lazy and sleepy after you eat a heavy meal but once that food is processed and the glucose begins to hit the bloodstream you going to have a surge of energy, then you have to wait for the blood sugar to return to normal.

Sleeping tablets are probably safer because its harder to get legally and a medical officer will assess you when you go for script. Generics are extremely cheap and they will knock you out cold, problem is they addictive hence S5 status.

I wouldnt import drugs from anywhere other than a proper pharmaceutical supplier and only if its MCC or FDA approved. Then you know whats stated is contained in the formulation is verified. Lots of people get scammed on the net because they sold sub standard medications or simply placebos. So rather pay up and be sure you getting what you suppose to get.

The package insert on a drug is not for the patient its for the professional, because the professional has the know how on how to process that information with regards to THAT patient getting it, something the internet cannot do. The internet (Dr Google) can only report the information from phase 3 and phase 4 clinical trails which is a very broadspectrum picture and almost nonsensical on face value. Its a big problem these days, patients read up on side effects then they get the side effects via a placebo effect. The placebo effect is extremely potent, I've tested the theory in practice myself with paracetamol, tell a patient its panado it wont work. Tell a patient its a strong painkiller and give a generic which is bioeqivalent and its magic. Paracetamol suffers the most because of the persona of easy available therefore its weak, yet its one of the most POTENT painkillers you can get. IV paracetamol (perfalgan®) is stronger than opioid class painkillers and is now the drug of choice for post-op analgesia ... lol

[joelus]

The MCC know more than you people. There is potential abuse with melatonin since it can cause vivid dreams. Its also been scheduled for its class which is hormones (S3 S4). Also keep in mind there are a lot of systems in play with deciding how the formulation interacts with the body. Its not simply wikipedia and google that will give you the full picture, pharmacodynamics and pharmacokinects are equally important and how it interacts with the body on a receptor level. Melatonin introduced synthetically will interfere with cardiac rythm, thats how it causes drowsiness. Though the dangerous thing about this it will disrupt what is known as a negative feedback cycle. Your body will stop producing its own melatonin with chronic use of the stuff, hence why its acceptable for an acute burst. In the long run, it will make your insomnia worse.

In the USA, and many other countries, it is sold as a dietary supplement and is available without prescription.
So the potential for abuse or the danger can't be very high.

I maintain that the reason it is scheduled here and in other countries is not because it is known to be dangerous or has the potential for abuse, but simply because the long term effects are unknown.

It is available here, for example, without a prescription, for short term use, eg: jetlag
A prescription is only required for long term use, as a sleeping aid, and that is just a precaution because of lack of research, not because it's dangerous or has the potential for abuse.

[RiaX]

In the USA, and many other countries, it is sold as a dietary supplement and is available without prescription.
So the potential for abuse or the danger can't be very high.

I maintain that the reason it is scheduled here and in other countries is not because it is known to be dangerous or has the potential for abuse, but simply because the long term effects are unknown.

It is available here, for example, without a prescription, for short term use, eg: jetlag
A prescription is only required for long term use, as a sleeping aid, and that is just a precaution because of lack of research, not because it's dangerous or has the potential for abuse.

Dont compare yourself to the USA, SA has a completely different set of people and have different genetics and our bodies behave differently when you deal with medicine and health you not allowed to be naive and say "everyone is equal" cause we not. Do you know hypertension treatment is different for black people as it is for white people ? And this is why organisations like the FDA and MCC are around. The MCC safeguards SOUTH AFRICAN people from drugs, by doing post marketing surveillence and they analyse drugs entering our market are what they suppose to be in accordance to the pharmcopeia and drug data, and good medical practice protocols. Its not done to make money its done to safe guard the patient, If a patient really needs it and its not registered then doctors will issue a section 21 form and have it brought in specifically for that patient (antibiotic polymixin E is an example of this). Another thing is this thing may interact with a SA food unique to us, the FDA wont flag it because they wont have this problem. Culture and demographics play a role as well, its not as simple as you think it is.

There are no studies yes you right with that but you lack the knowledge of how hormones work, I dont so I dont need research to extrapolate a conclusion that its not safe for chronic use. From melotonin, thyroxin, oestrogen, testosterone, corticosteroids to serotonin they are all governed by unique cycles, and unless you know those cycles in detail: how they boosted, inhibited, how the cycles play a role in homeostatis, physiological changes of the body when indueced/reduced, pathological and neurological changes that affect the system, do not say otherwise when you try and seperate the human body's functions you will fail because there are no isolated systems in the human body. As I said it will be bad for you in the long run, and I say that with confidence as I am a qualified pharmacist and im one of the best :P though I know you probably wont believe me because wikipedia and google know everything isnt ?

And yes it has potential for abuse because it can cause vivid dreams and can be used in an arb fashion to which we refer to as "off-label" use. Same reason pseudoephidrine became S6 drug and now you limited to buy it (it can no longer be bought in bulk OTC and will not be available on its own only in combination for S2), do you know why? because its was being used to make tik ... go find research on that. Anything that causes vivid dreams will be flagged as a substance of potential abuse, take efavirenz (ARV) for example. It causes vivid dreams and now the patients smoke it to get strongrt vivid dreams, they abuse the drugs left right and centre. Its become a pseudo-S6 drug in government practice. main component of whoonga/hunga however you spell it

[Garyvdh]

You say we should not use the Internet for advice (Dr. Google), yet here you are giving us medical advice on the Internet?

Why should we believe you?

[noxibox]

The MCC know more than you people

Your childlike faith in the MCC is very touching. Naive, but cute.

Unfortunately your experience and hearsay doesn't constitute scientific research. It's scheduled because research into long term use has not been done and the consequences of long term use are thus not known.

It's irrelevant whether formal research has been done. We all know it probably won't get done because no-one can patent and milk the product. It has been used long term worldwide, so there is no issue with finding clear examples of widespread harm from it's use. If they existed.

Dont compare yourself to the USA, SA has a completely different set of people and have different genetics and our bodies behave differently when you deal with medicine and health

What a load of complete tripe.

The MCC safeguards SOUTH AFRICAN people from drugs

They're safeguarding something, but our health, that's very doubtful. Of course besides being corrupt they may also be a victim of a delusion called the precautionary principle.

[joelus]

It's irrelevant whether formal research has been done. We all know it probably won't get done because no-one can patent and milk the product. It has been used long term worldwide, so there is no issue with finding clear examples of widespread harm from it's use. If they existed.

Your old man like cynicism is very touching. Jaded, but cute.

The fact that it has been used long term worldwide is irrelevant, since it has NOT been used long term in a scientific study or a scientific context. Homoeopathy mixtures have also been used long term worldwide with apparently miraculous results and we know how reliable that is! Of course companies can milk it, there are companies producing it now, go to the shop and buy some, and I'm sure they would all like bigger profits from it.

Melatonin is a safe, non-toxic supplement in the short-term, reports the National Institutes of Health, but human trials are few and far between for its long-term administration. Animal research indicates that the long-term use of melatonin is safe for rats and gerbils, although these findings are considered preliminary, according to a 1995 study published in the journal "Neuroreport." Bottom line: melatonin should not be used as a dietary supplement for long periods of time until more information is known about its long-term effects.

Read more: http://www.livestrong.com/article/11...#ixzz238ZHZhj0

Which is why, in this country, it has two schedules:
Melatonin is Schedule 4, except when used for the treatment of desyncronosis (jet-lag) in doses not exceeding 6mg daily.
It is Schedule 2 when used for the treatment of desyncronosis (jet-lag) in doses not exceeding 6mg daily.

Why have two different schedules if not because safety has been established for short term use (fact) but not long-term administration (fact)?

[RiaX]

You say we should not use the Internet for advice (Dr. Google), yet here you are giving us medical advice on the Internet?

Why should we believe you?

Hmmm, suppose so. Im killing time here for a while, you dont have to believe me if you dont want to. Would be your loss though :P

Your childlike faith in the MCC is very touching. Naive, but cute.

Ever seen how they work? know anyone on the board? ... I have and I do. Classic case of a fool who knows nothing and talks as if he does.

It's irrelevant whether formal research has been done. We all know it probably won't get done because no-one can patent and milk the product. It has been used long term worldwide, so there is no issue with finding clear examples of widespread harm from it's use. If they existed.

LOL, really do you have ANY idea what you saying here? research could be done if its viable and not to patent and milk the product, when people need masters PhD ect they do this form of research. The reason its not done is because its pointless like I've stated before any real medical practioner knows this.

What a load of complete tripe.

really and you base this on what? heard of these little books known as EP, JP, USP ? .... what arrogance.

If you want proof of this look into ACE inhibiters in black patients vs white patients without the use of a diuretic to induce the renin-angiostensin-aldosterone sytem and it will provide you with proof how important populations are to pharmaceuticals.

They're safeguarding something, but our health, that's very doubtful. Of course besides being corrupt they may also be a victim of a delusion called the precautionary principle.

Again based on what your idiotic conspiracy theories you dream up ? making statements as if you speak the truth and not a shread of evidence for this madness.



Sigh just because its marketed as natural doesnt mean its safe. Cyanide is natural go take it? melotonin is a hormone so if you think long term its safe go for it just dont whine when you cant sleep when you stop it.

[Korn1]

What else can one take to help with sleep? I always wake up around 3am and then battle to sleep.

[AstroTurf]

Back to moneymoneymoney I would imagine.

[joelus]

Back to moneymoneymoney I would imagine.

Makes no sense...