Insomnia drug helps jet-lag, shift-work troubles

Reported by Reuters:
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Insomnia drug helps jet-lag, shift-work troubles
Mon Dec 1, 2008 6:39pm EST

WASHINGTON (Reuters) - An insomnia drug that helps the body produce more of the sleep hormone melatonin may improve sleep for jet-lagged travelers and shift workers, researchers reported on Monday.

Maryland-based Vanda Pharmaceuticals Inc. reported on two studies of its drug tasimelteon, also known as VEC-162, that showed it helped patients sleep longer and more deeply than a placebo.

They said that people with so-called circadian rhythm disorders could be helped. These disorders are common causes of insomnia that affect millions of people whose activities are out of sync with their internal body clocks.

These disorders entail persistent sleep disturbances, insomnia when trying to sleep and excessive sleepiness while trying to remain awake, the researchers said.

"...Tasimelteon has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders, including people affected by jet lag, or those who work at night, and early-riser workers," they wrote in their report, published in the Lancet medical journal.

Dr. Shantha Rajaratnam of Brigham and Women's Hospital and Harvard Medical School in Boston and colleagues, working with the company, did both Phase II and Phase III trials of the drug, aiming to show it is safe and works.

Volunteers slept in labs and were tested using devices known as polysomnographs, which measure sleep activity.

Patients given tasimelteon fell asleep faster, had better sleep and woke up faster, they reported. The drug did not cause any more side-effects than a placebo, they noted.

Melatonin can fight jet lag too but over-the-counter melatonin products are not regulated, they pointed out, and have not been consistently shown to help treat jet lag and other sleep disorders.

The market is potentially large. The study quoted U.S. labor statistics as finding that about 20 percent of the workforce or about 19.7 million U.S. workers are early risers who start work between 2:30 a.m. and 7 a.m.

"Most of these people probably experience chronic sleep restriction because they are unable to initiate and maintain sleep when they attempt to sleep in the early or late evening hours. Tasimelteon might alleviate this problem by advancing the sleep-wake cycle, by providing a direct sleep-promoting effect, or both," they wrote.

In a commentary, Dr. Daniel Cardinali of the University of Buenos Aires and Dr Diego Golombek, National University of Quilmes in Argentina, noted that drugs such as valium can be addictive.

"Shift-workers, airline crew, tourists, football teams, and many others will welcome the results of Shantha Rajaratnam and colleagues' study in The Lancet today," they wrote.
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OldLincoln wrote:Reported by Reuters:
======================
Insomnia drug helps jet-lag, shift-work troubles
Mon Dec 1, 2008 6:39pm EST

WASHINGTON (Reuters) - An insomnia drug that helps the body produce more of the sleep hormone melatonin may improve sleep for jet-lagged travelers and shift workers, researchers reported on Monday.

Maryland-based Vanda Pharmaceuticals Inc. reported on two studies of its drug tasimelteon, also known as VEC-162, that showed it helped patients sleep longer and more deeply than a placebo.

They said that people with so-called circadian rhythm disorders could be helped. These disorders are common causes of insomnia that affect millions of people whose activities are out of sync with their internal body clocks.

These disorders entail persistent sleep disturbances, insomnia when trying to sleep and excessive sleepiness while trying to remain awake, the researchers said.

"...Tasimelteon has the potential for the treatment of patients with transient insomnia associated with circadian rhythm sleep disorders, including people affected by jet lag, or those who work at night, and early-riser workers," they wrote in their report, published in the Lancet medical journal.

Dr. Shantha Rajaratnam of Brigham and Women's Hospital and Harvard Medical School in Boston and colleagues, working with the company, did both Phase II and Phase III trials of the drug, aiming to show it is safe and works.

Volunteers slept in labs and were tested using devices known as polysomnographs, which measure sleep activity.

Patients given tasimelteon fell asleep faster, had better sleep and woke up faster, they reported. The drug did not cause any more side-effects than a placebo, they noted.

Melatonin can fight jet lag too but over-the-counter melatonin products are not regulated, they pointed out, and have not been consistently shown to help treat jet lag and other sleep disorders.

The market is potentially large. The study quoted U.S. labor statistics as finding that about 20 percent of the workforce or about 19.7 million U.S. workers are early risers who start work between 2:30 a.m. and 7 a.m.

"Most of these people probably experience chronic sleep restriction because they are unable to initiate and maintain sleep when they attempt to sleep in the early or late evening hours. Tasimelteon might alleviate this problem by advancing the sleep-wake cycle, by providing a direct sleep-promoting effect, or both," they wrote.

In a commentary, Dr. Daniel Cardinali of the University of Buenos Aires and Dr Diego Golombek, National University of Quilmes in Argentina, noted that drugs such as valium can be addictive.

"Shift-workers, airline crew, tourists, football teams, and many others will welcome the results of Shantha Rajaratnam and colleagues' study in The Lancet today," they wrote.
=====================

Typical Press Release by a drug company. Every study ever done for jet-lag shows OTC melatonin helps with jet-lag, only difference is you cannot make MONEY on unregulated melatonin. They try to scare everyone into taking meaning-less low doses of OTC melatonin so they can show it don't work. One study done was using 300mcg of melatonin, not strong enough to put a rat to sleep much less a human being. Then they used college students who were under 35 who by age produce more melatonin naturally than those over 50.

Think I'm going to stick with the bottle of 300 tablets of Schiff brand Melatonin I get at Costco for $6 bucks, that bottle lasts me a nearly a year and it works great for me.

All regulation does is pad the price you have to pay for it. We seen how well the SEC has regulated Wall Street, how well the Fed has regulated the banks.

Interesting stuff.....my question is:
What is a normal dose of OTC Melatonin and how much can be tolerated ?
I take 2 of the little pills..I think they're 3 each.
Can't say they help me fall or stay asleep though.

Don't want to overdo it.

Luke

Snoredog wrote:...

Typical Press Release by a drug company. Every study ever done for jet-lag shows OTC melatonin helps with jet-lag, only difference is you cannot make MONEY on unregulated melatonin. They try to scare everyone into taking meaning-less low doses of OTC melatonin so they can show it don't work. One study done was using 300mcg of melatonin, not strong enough to put a rat to sleep much less a human being.


Think I'm going to stick with the bottle of 300 tablets of Schiff brand Melatonin I get at Costco for $6 bucks, that bottle lasts me a nearly a year and it works great for me.

..

What dose is effective? What dose do you use?

How much melatonin is effective depends on the individual and the situation. I have seen melatonin packaged in .5, 1 and 3 mg. It can also be obtained (usually by prescription) in 20 mg capsules. (This latter has been used by some naturopaths for cancer treatment.)

Snoredog is correct about the "warning" about "unregulated supplements." Melatonin can't be patented, and it's relatively easy to synthesize, hence, there's no profit in it, and it is in the pharmaceutical companies' best interests to steer people away from it. Similarly, niacin is good for cholesterol, but unpatentable. And then there's CoQ10 (CoEnzyme Q10) which is top mark for heart issues, energy, and etc. It's one of the safest and most effective products around for congestive heart failure. (I had the pleasure of reading some discussions with one of the primary researchers in COQ10.) But again, unpatentable, so therefore, no Company research, and relatively few doctors are aware of it. There's also at least one small study which indicates CoQ10 is anti breast cancer.

However, I digress. I typically took one 3 mg capsule of melatonin at bedtime, then read for awhile before turning in. Melatonin never "made" me sleep, but it allowed me to drift off, and usually stay alseep. Well, until my apnea began causing hip pain which woke me up, but that's another story. Took almost seven years for someone to figure out the hip pain was caused by apnea.

Earlier this year, I has a diagnosis of endometrial cancer and my stress levels went through the roof. I ended up taking 6-7 3 mg capsules to get to sleep and stay asleep. After my successful surgery, I dropped back to three 3 mg capsules.

After about two weeks on CPAP, I was finding myself waking up, and then dr-a-a-g-g-ing my way through the day, and wondering what the <bleep> was wrong with my therapy, 'cause I'd mostly gotten the leaks under control and the AHI is decent, if not what I'd like to ultimately achieve. Then it dawned on me. I was sleeping better because of the CPAP and didn't need as much melatonin to achieve the same amount of deep sleep. I've dropped back to my original one 3 mg capsule, and that's much better. However, I may pick up some 1 mg capsules the next time I hit the Vitamin Shoppe, and see if I can get it to the minimum dose necessary.

My suggestion would be to start with one 1 mg capsule and see how you do for a few nights. Then adjust up if needed. Most people I have known use one 3 mg capsule, but it's hard to split one of those if you need to adjust down.

OldLincoln wrote:Reported by Reuters:
======================
Melatonin can fight jet lag too but over-the-counter melatonin products are not regulated ....

Snoredog wrote:Every study ever done for jet-lag shows OTC melatonin helps with jet-lag, only difference is you cannot make MONEY on unregulated melatonin. They try to scare everyone into taking meaning-less low doses of OTC melatonin so they can show it don't work. One study done was using 300mcg of melatonin, not strong enough to put a rat to sleep much less a human being. Then they used college students who were under 35 who by age produce more melatonin naturally than those over 50.

Think I'm going to stick with the bottle of 300 tablets of Schiff brand Melatonin I get at Costco for $6 bucks, that bottle lasts me a nearly a year and it works great for me.

Kiralynx wrote:How much melatonin is effective depends on the individual and the situation....

.... And then there's CoQ10 (CoEnzyme Q10) ....

.... I typically took one 3 mg capsule of melatonin at bedtime, then read for awhile before turning in. Melatonin never "made" me sleep, but it allowed me to drift off, and usually stay alseep. .... Earlier this year, I has a diagnosis of endometrial cancer and my stress levels went through the roof. I ended up taking 6-7 3 mg capsules to get to sleep and stay asleep. After my successful surgery, I dropped back to three 3 mg capsules.

After about two weeks on CPAP, I was finding myself waking up, and then dr-a-a-g-g-ing my way through the day, and wondering what the <bleep> was wrong with my therapy, 'cause I'd mostly gotten the leaks under control and the AHI is decent, if not what I'd like to ultimately achieve. Then it dawned on me. I was sleeping better because of the CPAP and didn't need as much melatonin to achieve the same amount of deep sleep. I've dropped back to my original one 3 mg capsule, and that's much better. ....

My suggestion would be to start with one 1 mg capsule and see how you do for a few nights. Then adjust up if needed. Most people I have known use one 3 mg capsule, but it's hard to split one of those if you need to adjust down.

Snoredog & Kiralynx (and any other knowledgable someone who wishes to chime in), I'm still chasing that "boy, did I sleep well" feeling, even though I've been on the hose since mid-August, have great leak rates and generally have an AHI of 0.0 to 0.3 w/ 1.5 being the highest since I adjusted my 9 cm Rx up to 12 a couple of months ago.

Actually getting 7 or 8 hours of sleep is a big problem, though, and I'm sure there are other things involved:
-- my age, which is 57.
-- PLMD, which is under control with 0.25 mg. Mirapex daily (0 and 0.1 arousals in titration studies 1 & 2, respectively).
-- Adderall usage for ADD; I'm in the process of weaning off it and have worked my way down from 60 mg. daily to 20 mg. daily w/ last dose ideally no later than 2 p.m. (ideally meaning the toughest thing for someone w/ ADD is to remember to take the stupid medicine). I'll be down to 10 mg. daily starting Sunday and zippo two weeks later. (Aside: If anyone knows of a good Adderall substitute that doesn't disrupt sleep, I'd be ecstatic. But Strattera didn't help with my focus issues at all.)
-- DJD (degenerative joint disease) pain, primarily in both knees, which is somewhat under control (meaning I can keep the sharp pains away) w/ a pillow under my knees when laying down plus 200 mg. Naproxen (Alleve) twice daily and 65 mg. propoxyphene/APAP (Wygesic) at bedtime.
-- Possibly insufficient deep & REM sleep. I hit all the stages during my initial PSG, but mostly stages 1 & 2; stages 1 and 2 and a little stage 3 during the two titration studies I've had since then; and no stage 4 or REM in the two titration studies. Unfortunately, although I have the program, I haven't gotten Encore up and running yet (requires setting up a new computer; working on it; perhaps this coming weekend), so I don't know how much I'm getting in any of the stages. Am I right in thinking that's a key question?

I've been taking 6 mg. melatonin for about a month and have been sleeping a little better, but that time frame also jives with weaning off Adderall, so I don't know if it's due to one or the other or both. But I'm still dragging during the day and still have very little energy.

I know a little about vitamins & supplements in general, and there are some brands that I trust more than others for certain things. What about melatonin? Is one brand about the same as another? In other words, Snoredog, do you go with the Schiff brand because it's the best price (because they're all about the same) or because you believe Schiff has a better product quality than others?

What's a good dosage for CoQ10? And again, is one brand better than another?

Until I actually have facts about my sleep stages, should I be taking a different dosage of the melatonin instead of the 6 mg. I've been taking?

Any/all thoughts would be very welcome.

Thanks!
Marsha

Snoredog wrote:Think I'm going to stick with the bottle of 300 tablets of Schiff brand Melatonin I get at Costco for $6 bucks, that bottle lasts me a nearly a year and it works great for me.

This sounds appealing to me. I currently take low dose Sonata but am considering alternatives. Any idea if Melatonin will do that? What strength do you buy?

Songbird wrote:Snoredog & Kiralynx (and any other knowledgable someone who wishes to chime in), I'm still chasing that "boy, did I sleep well" feeling, even though I've been on the hose since mid-August, have great leak rates and generally have an AHI of 0.0 to 0.3 w/ 1.5 being the highest since I adjusted my 9 cm Rx up to 12 a couple of months ago.

<chuckle> I've only been on the hose a month. Most AHIs are around 2.0, and I think, with the purchase of two new side sleeper pillows, I may have found a solution for a decent leak rate, though I still haven't sorted out why I have more hypopneas sleeping on my right side than on my left.

Actually getting 7 or 8 hours of sleep is a big problem, though, and I'm sure there are other things involved:
-- my age, which is 57.

I'm not far behind you, at 56.5 years.

-- PLMD, which is under control with 0.25 mg. Mirapex daily (0 and 0.1 arousals in titration studies 1 & 2, respectively).

Can't speak to this as I know nothing about it, except what I've learned here on CPAPTalk.Com!

-- Adderall usage for ADD; I'm in the process of weaning off it and have worked my way down from 60 mg. daily to 20 mg. daily w/ last dose ideally no later than 2 p.m. (ideally meaning the toughest thing for someone w/ ADD is to remember to take the stupid medicine). I'll be down to 10 mg. daily starting Sunday and zippo two weeks later. (Aside: If anyone knows of a good Adderall substitute that doesn't disrupt sleep, I'd be ecstatic. Don't suggest Strattera, because I've tried that and it didn't help with my focus issues at all.)

Look into dietary treatments. Boot sugar, starch, high fructose corn syrup and other crapola in the keister and get it out of your diet. ADD runs in my family. I've gotten my symptoms under control with the Specific Carbohydrate Diet. THere was a short off-topic thread about it here:

viewtopic.php?f=1&t=36152&p=312315&hilit=SCD#p312315

<evil grin> My co-author often says she wishes I'd have LESS focus, 'cause I'm driving her crazy.

-- DJD (degenerative joint disease) pain, primarily in both knees, which is somewhat under control (meaning I can keep the sharp pains away) w/ a pillow under my knees when laying down plus 200 mg. Naproxen (Alleve) twice daily and 65 mg. propoxyphene/APAP (Wygesic) at bedtime.

That, too, is no fun. I thought I had it... but interestingly, getting my therapy going has significantly reduced my pain issues. Ask about getting water therapy -- and then make it a point to do your therapy at least three times a week. It helps. Really.

-- Possibly/probably insufficient deep and REM sleep. I did hit all of the stages during my initial PSG, but mostly stages 1 & 2; stages 1 and 2 and a little stage 3 during the two titration studies I've had since then; and no stage 4 or REM in the two titration studies. Unfortunately, although I have the program, I haven't gotten Encore up and running yet (requires setting up a new computer; working on it; perhaps this coming weekend), so I don't know how much I'm getting in any of the stages. Am I right in thinking that's a key question?

Not my area of expertise. I hope to have Encore Pro up when I get the new computer. Then I'll know more about me.

I've been taking 6 mg. melatonin for about a month. I have been sleeping a little better, but that time frame also jives with weaning off the Adderall, so I don't know if it's due to one or the other or both. But I'm still dragging during the day, and my energy level's in the cellar.

I don't know enough about Adderall to really say... but you may find that you need less melatonin as your Adderall dose decreases. Too much melatonin at night can result in day-time dragginess. Also, if you have that dragginess, look into taking some B12 first thing in the morning, as that can help your body get rid of excess melatonin, and help you stay awake.

I know a little about vitamins & supplements in general, and there are some brands that I trust more than others for certain things. What about melatonin? Is one brand about the same as another?

I'd look for straight melatonin, without the added B6 that some brands have. B6 can make some folks hyper, although please don't ask me where I got that from.

What's a good dosage for CoQ10? And again, is one brand better than another?

That depends on what you;re using it for. Prior to my cancer diagnosis, I was using about 100mg in divided doses. I used significantly more when I was healing from the surgery. Now I'm back down again. The older you get, generally, the more is needed.

Until I actually have facts about my sleep stages, should I be taking a different dosage of the melatonin instead of the 6 mg. I've been taking?

If you're dragging during the day, it may be too much for you, especially as you reduce the Adderall. You might consider dropping down to 3 mg.