Question for GP's and Pharmacists!

[BazzaS]

All melatonin on the market is synthetic, unless it's "homoeopathic" melatonin, in which case it's basically placebo.

 

On which market?.

 

If "bought on the Internet " how are you as sure of the provenance of supply?

[san_d]

On which market?.

 

If "bought on the Internet " how are you as sure of the provenance of supply?

I've bought reputable USA brands form reputable US websites. The same brands are also on Amazon USA and other websites. The supplements manufacturing standards in the USA are the strictest.

[BazzaS]

I've bought reputable USA brands form reputable US websites. The same brands are also on Amazon USA and other websites. The supplements manufacturing standards in the USA are the strictest.

 

I'm glad you have found a reliable supply.

 

My response was because you'd said "all on the market", and I'm still not sure "all" are safe / reliable.

 

If you are saying that the suppliers you use in the USA meet stringent standards then it is good that we can point people there.

 

Who monitors the standards for 'supplement' melatonin in the USA? (as opposed to 'medicinal' melatonin which would fall under the FDA)

[mr_mastiff]

It isn't clear what med the OP was referring to .

 

Melatonin has been mentioned, and now 5-htp.

Melatonin (n-acetyl-5MTP) has been conflated with 5-htp in the past, so I'm not sure if wires have been crossed here too.

 

Melatonin is licensed by the European Medicines Agency, whose product license is for short term insomnia treatment in the over-55's.

It is a prescription only medicine within the UK

 

For those who might be considering sourcing melatonin outside the UK (legally) : where it can't legally be sold openly in the UK : I 'm aware of at least one sleep physician who has highlighted use of melatonin, but advised anyone considering importing melatonin to look at its source.

 

Synthesized melatonin is considered less of a risk of infection than melatonin derived from animal pineal tissue.

 

 

BassaS, I did get my wires crossed somewhat. It is licensed and its use is restricted.

 

The point I am trying to get across is that this medication if used outside its licence and/or in combination with other medications could cause a problem. The reason why its use is restricted is there are still areas where its effects are not known.

 

There is a classic example of a medication that was licensed to treat nausea in the elderly. GP,s started to give it to other much younger groups with devastating consequences, that drug was thalidomide.

 

For clarity all I am trying to prevent is before taking this medication make sure it will do more good than harm.

[sillygirl1]

Sorry to contradict San_d but there is NO limit on the length of a drug study, 6 weeks is rubbish (it may be that in the USA but here it is much longer, there are 2 and 3 year trials currently in progress on some cancer drugs - I know because I've worked in the NHS and have had access to drug trial information).

[san_d]

Sorry to contradict San_d but there is NO limit on the length of a drug study, 6 weeks is rubbish (it may be that in the USA but here it is much longer, there are 2 and 3 year trials currently in progress on some cancer drugs - I know because I've worked in the NHS and have had access to drug trial information).

The FDA will usually accept a period of 6 weeks as enough to prove the efficacy of a drug. It's not written in stone but it's industry standard. When it comes to the UK, there's no evidence that the Medicines and Healthcare products Regulatory Agency (MHRA) is stricter in their requirements.

 

The restriction imposed on the sale of melatonin was not decided by the MHRA but purely by political pressure:

http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con2031060.pdf

 

Subject: FOI 06/276

I would like to make a formal request under the Freedom of Information Act for the following:-

1. Details of research conducted by the MHRA prior to the restriction imposed on the sale of melatonin

1. Details of research conducted by the MHRA prior to the restriction imposed on the sale of melatonin

2. Information about the cost of any research, by whom it was conducted and whether it was subject to

external or peer review

3. Details of any consultation carried out to review this policy since it came into effect

4. How many queries or complaints have been received from the public or elsewhere since the restriction

was imposed.

 

MHRA Reply:

FREEDOM OF INFORMATION REQUEST 06/276 MELATONIN

I refer to your e-mail request of 19 August 2006 and our subsequent correspondence.

The answers to the four questions you asked are as follows –

1. & 2. The Agency did not carry out any primary research on melatonin and therefore has no information

about the cost of research carried out on melatonin.

3. No consultations over the status of melatonin have been carried out since the Agency made its

determination.

4. Records held by the Medicines Borderline Section indicate that there have been 135 specific

referrals about melatonin since first considering the substance in 1989. It is possible that there have been

other referrals where a melatonin product was one of a number of products being complained about but it

is not possible to identify the number of these cases without a detailed scrutiny of a large number of

paper records.

[sillygirl1]

The FDA are an American organisation and their studies are not normally acceptable in the UK, as I stated before, I have worked in the NHS, dealing with NICE and within the management of the NHS and know that 6 weeks is NOT enough to determine the long term effects of drugs.

 

Initial trials are usually far longer here, I will find my link where you can join in drug trials, it explains the rules and the length of time the trials take - it certainly is far longer than 6 weeks.

 

I'm not going to labour that point any more, because it will only end up in a 'flame' war.

 

I've taken part in drug studies for sleep problems and the shortest of those were 3 months. I've had chronic insomnia for years and am pretty much an expert in the subject.

 

Non-drug intervention is by far the best, keeping the bedroom just for sleeping and intimate sessions, changing the bed sheets, pillow cases and quilt cover twice a week, making sure the temperature is ideal for you, air flow, sweet milky drink 1/2 hour before bedtime, saying the rosary (you don't need to be religious to do this, you can use any prayer you want - or any 'mantra' - this relaxes the mind and clears it of distracting thoughts, you only need to do one decade).

[aDvicePls]

I think he is on the same medication as me Mirtazapine. I had a similar problem about six months ago. I am a member of a self help group on another site, there have been a number of issues reported with both this medication and other MH medications. BazzaS gave an excellent run down of causes.

 

The sleep clinic is an excellent idea the only problem in my area there is a very strict criteria for referral.

 

Mr Mastif - you are right - the medication is called Mirtazapine - and it no longer seems to be working.

You say there have been a number of issues with this medication, can you elaborate?

Also, what is the name of the self-help group?

It sounds as if other people could be having the same problem as me...........

 

An update:

 

I went to a different chemist and received another brand (also generic) - and that doesn't seem to be working either - still no sleep.

 

There has obviously been a serious drop in quality in this medication recently - as the old batch of tablets I found worked perfectly well.

 

-either that or I have become immune.

 

(seems like another trip to the doctor is on the cards

Edited October 15, 2013 by aDvicePls

[sillygirl1]

With some medication you do get 'breakthrough insomnia' which is really bad, I've had it in the past when on Zopiclone.

 

Once you get over this stage (which usually lasts about 3-4 weeks) then the medication starts working again. It is your body's way of fighting what it sees as 'an attack'.

 

The funding for the majority of sleep clinics has been severely cut, and the criteria is changing again next month, so maybe it will be loosened, the idea is to get all sleep clinics privately funded by drugs companies and the local PCTs (or whoever is in charge of the budgeting for NHS treatment for your area) then can allocate their resources to serve 'the wider community'. ie privatising by the back door.

[mr_mastiff]

Mr Mastif - you are right - the medication is called Mirtazapine - and it no longer seems to be working.

You say there have been a number of issues with this medication, can you elaborate?

Also, what is the name of the self-help group?

It sounds as if other people could be having the same problem as me...........

 

An update:

 

I went to a different chemist and received another brand (also generic) - and that doesn't seem to be working either - still no sleep.

 

There has obviously been a serious drop in quality in this medication recently - as the old batch of tablets I found worked perfectly well.

 

-either that or I have become immune.

 

(seems like another trip to the doctor is on the cards

 

Hi ADvicePls, Over the last 3 to 9 months a number of people have reported similar problems to yours. Some like you changed their chemist and got a different batch with good results. However because we all live quite near to each other some of the people swapped when they found a good one and did not have the same effect. I think Sillygirl1 could have an explanation for some of the problems reported.

 

The group I belong to in is just a number of people who were in hospital at the same time and have kept in contact.

[aDvicePls]

Thanks Mr Mastiff - I might mention it to the Doc (I expect I will get treated like a hypochondriac), but its worth a try.

[aDvicePls]

With some medication you do get 'breakthrough insomnia' which is really bad, I've had it in the past when on Zopiclone.

 

Once you get over this stage (which usually lasts about 3-4 weeks) then the medication starts working again. It is your body's way of fighting what it sees as 'an attack'.

 

The funding for the majority of sleep clinics has been severely cut, and the criteria is changing again next month, so maybe it will be loosened, the idea is to get all sleep clinics privately funded by drugs companies and the local PCTs (or whoever is in charge of the budgeting for NHS treatment for your area) then can allocate their resources to serve 'the wider community'. ie privatising by the back door.

 

sillygirl, it can't be breakthough insomnia as I have been taking it for about 2 years.

[mr_mastiff]

Thanks Mr Mastiff - I might mention it to the Doc (I expect I will get treated like a hypochondriac), but its worth a try.

 

 

Yes i know the feeling until the GP received the result of my scans I had a Hypochondriac question mark against me. I was just wondering if your GP would do Mirtazapine blood levels to see if they are in the therapeutic range.

 

It would give a definite answer to the viability of the medication.