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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 70. This is the beginning of the thread.
Posted by jrbecker on July 23, 2005, at 13:24:47
FDA OKs new sleep medication Rozerem
http://www.chicagotribune.com/business/chi-0507230014jul23,1,4523976.story?coll=chi-business-hedFDA OKs new sleep medication Rozerem
Dow Jones Newswires
Published July 23, 2005
The Food and Drug Administration on Friday approved a new prescription sleep medication that has shown no evidence of abuse and dependence.The drug, Rozerem, targets receptors in an area of the brain that regulates 24-hour, or circadian, rhythms including the sleep-wake cycle, said Takeda Pharmaceuticals North America Inc., a unit of Takeda Pharmaceutical Co., Japan's largest pharmaceutical company.
It will be available for patients by late August. The FDA approval allows physicians to prescribe Rozerem for long-term use in adults.
Posted by ed_uk on July 23, 2005, at 13:43:24
In reply to FDA okays sleep drug Rozerem(TM) (ramelteon), posted by jrbecker on July 23, 2005, at 13:24:47
Hi J,
Thanks for posting, that's good news. You're a great source of information!
~Ed
Posted by ed_uk on July 23, 2005, at 13:45:01
In reply to FDA okays sleep drug Rozerem(TM) (ramelteon), posted by jrbecker on July 23, 2005, at 13:24:47
PS. Do you have any idea when ramelteon will be available in Europe?
~Ed
Posted by ed_uk on July 23, 2005, at 14:07:20
In reply to FDA okays sleep drug Rozerem(TM) (ramelteon), posted by jrbecker on July 23, 2005, at 13:24:47
PS. What advantages does ramelteon have over melatonin?
~Ed
Posted by SLS on July 23, 2005, at 14:18:23
In reply to FDA okays sleep drug Rozerem(TM) (ramelteon), posted by jrbecker on July 23, 2005, at 13:24:47
Holy crap!
We must be talking suprachiasmatic nucleus here or some sort of fancy word.
This is truly novel! It must be the antithesis of Provigil.
No time to look it up, though. Not enough sleep last night. Must nap. :-)
- Scott
Posted by ed_uk on July 23, 2005, at 16:54:07
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon), posted by SLS on July 23, 2005, at 14:18:23
Hi Scott,
Since it's a melatonin agonist, do you think it will have any advantages over plain melatonin?
~Ed
Posted by Jakeman on July 23, 2005, at 19:31:47
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon) » SLS, posted by ed_uk on July 23, 2005, at 16:54:07
Perhaps it acts as a more potent version of melatonin. From what I've read, ramelteon dosen't help much in terms of increasing total sleep time. I wonder if doctors will combine it with other sleep meds.
best regards ~Jake
Posted by Phillipa on July 23, 2005, at 20:38:36
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon), posted by Jakeman on July 23, 2005, at 19:31:47
So this is totally different than lunesta? Fondly,Phillipa
Posted by djmmm on July 23, 2005, at 21:20:04
In reply to FDA okays sleep drug Rozerem(TM) (ramelteon), posted by jrbecker on July 23, 2005, at 13:24:47
I would bet that a melatonin supplement will work just as well...I believe that this new "medication" is probably just a way around the manufacturing and marketing of melatonin (which is an unrestricted supplement) I think someting similar is going on with Omega fatty acids.
Posted by Jakeman on July 23, 2005, at 23:32:48
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon), posted by Phillipa on July 23, 2005, at 20:38:36
> So this is totally different than lunesta?
Yes it has a completely different mechanism of action than other sleep medications.
http://www.rozerem.com
http://mediwire.healingwell.com/main/Default.aspx?P=Content&ArticleID=164885warm regards ~Jake
Posted by linkadge on July 24, 2005, at 3:09:18
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon), posted by djmmm on July 23, 2005, at 21:20:04
I agree. Whenever a nutritional supplement proves to be an effective alternative to a prescription it poses a significant risk to sales. The drug companys bottle it, then take it off the market.
I'd like to see a head to head comparison of Ramelton, and melatonin.
Linkadge
Posted by Cecilia on July 24, 2005, at 4:47:42
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon) » jrbecker, posted by ed_uk on July 23, 2005, at 14:07:20
> PS. What advantages does ramelteon have over melatonin?
>
> ~EdAdvantages to the financial health of the manufacturer. Cecilia
Posted by ed_uk on July 24, 2005, at 4:54:47
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon), posted by djmmm on July 23, 2005, at 21:20:04
Hi,
>I would bet that a melatonin supplement will work just as well...I believe that this new "medication" is probably just a way around the manufacturing and marketing of melatonin (which is an unrestricted supplement)
I've been thinking the same thing. Ramelteon will be useful if it gets approved in the UK though because melatonin is not approved here.
>I think someting similar is going on with Omega fatty acids.
We've already got Omacor in the UK!~Ed
Posted by ed_uk on July 24, 2005, at 4:56:21
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon) » Phillipa, posted by Jakeman on July 23, 2005, at 23:32:48
Hi Jake!
Thanks for the links :-)
Kind regards
~Ed
Posted by ed_uk on July 24, 2005, at 4:57:13
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon), posted by Cecilia on July 24, 2005, at 4:47:42
>Advantages to the financial health of the manufacturer.
LOL!
~Ed
Posted by ed_uk on July 24, 2005, at 4:58:30
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon) » djmmm, posted by linkadge on July 24, 2005, at 3:09:18
>Whenever a nutritional supplement proves to be an effective alternative to a prescription it poses a significant risk to sales.
Melatonin isn't even available here! Also, I've read that its illegal to import it into the UK.
~Ed
Posted by ed_uk on July 24, 2005, at 6:38:48
In reply to Re: FDA okays sleep drug Rozerem(TM) (ramelteon) » linkadge, posted by ed_uk on July 24, 2005, at 4:58:30
So, Rozerem will be available in the US in about a month?? I hope it won't be delayed as much as Lunesta was!
From the Rozerem website..........
>The body's own melatonin binds to MT1 and MT2 receptors in the SCN, suppressing the circadian alerting signal. This is believed to facilitate sleep.
>ROZEREM (ramelteon) is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors and selectivity over the MT3 receptor.
The activity of ramelteon at the MT1 and MT2 receptors is believed to contribute to its sleep-promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle.
My question........
How does the hypnotic efficacy of ramelteon differ from that of melatonin?
What does the MT3 receptor do?
>M-II (the major active metabolite of ramelteon) has weak affinity for the serotonin 5-HT2B receptor..........
What is the significance of this??
>DOSAGE AND ADMINISTRATION
>The recommended dose of ROZEREM is 8 mg taken within 30 minutes of going to bed. It is recommended that ROZEREM not be taken with or immediately after a high fat meal.
>HOW SUPPLIED?
>ROZEREM is available as round, pale orange-yellow, film-coated, 8 mg tablets.
>Controlled Trials Supporting Efficacy
Although ramelteon can help people fall asleep, it doesn't appear to increase total sleep time. Mild residual effects were observed the following day.
>Rebound Insomnia/Withdrawal
No w/d symptoms were detected. Let's see whether ramelteon lives up to its promise.
>Abnormalities were, however, noted within the reproductive axis. Overall, the mean serum prolactin level change from baseline was 4.9 µg/L (34 % increase) for women in the ROZEREM group compared with -0.6 µg/L (4% decrease) for women in the placebo group (p=0.003). No differences between active- and placebo-treated groups occurred among men. Thirty-two percent of all patients who were treated with ramelteon in this study (women and men) had prolactin levels that increased from normal baseline levels compared to nineteen percent of patients who were treated with placebo.
Oh dear.
>In a 12-month, open-label study in adult and elderly patients, there were two patients who were noted to have abnormal morning cortisol levels, and subsequent abnormal ACTH stimulation tests.
A 29-year-old female patient was also diagnosed with a prolactinoma.
Hmmm.......
>ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Makes sense.
>The failure of insomnia to remit after a reasonable period of treatment may indicate the
presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, may be the result of an unrecognized underlying psychiatric or physical disorder and requires further evaluation of the patient.Is this a euphemistic way of saying that ramelteon can cause psychiatric adverse effects LOL?! A bit like 'Halcion may uncover depressive tendencies'.
>As with other hypnotics, exacerbation of insomnia and emergence of cognitive and behavioral abnormalities were seen with ROZEREM during the clinical development program.
:-(
>Patients should be advised to take ROZEREM within 30 minutes prior to going to bed.....
Useful to know :-)
>Patients should be advised that they should not take ROZEREM with or immediately after a high fat meal.
Delays the onset of action.
>Patients should consult their health care provider if they experience one of the following: cessation of menses or galactorrhea in females, decreased libido, or problems with fertility.
Signs of hyperprolactinemia.
>For patients presenting with unexplained amenorrhea, galactorrhea, decreased libido, or problems with fertility, assessment of prolactin levels and testosterone levels should be considered as appropriate.
Ramelteon can apparantly lower testosterone levels, as well as increasing prolactin.
>ROZEREM has a highly variable inter-subject pharmacokinetic profile (approximately 100% coefficient of variation in Cmax and AUC).
That's not what we like to hear! Presumably, more 'individualisation' of dosing will be required to optimise the effect. Doctors don't like this! Anyway, Rozerem only comes as an 8mg tablet.
>CYP1A2 is the major isozyme involved in the hepatic metabolism of ramelteon....
>Fluvoxamine (strong CYP1A2 inhibitor): When fluvoxamine 100 mg twice daily was administered for 3 days prior to single-dose co-administration of ROZEREM 16 mg and fluvoxamine, the AUC0-inf for ramelteon increased approximately 190-fold, and the Cmax increased approximately 70-fold, compared to ROZEREM administered alone.
Whoa! Take care if you're on Luvox.
>Adverse Reactions Resulting in Discontinuation of Treatment Five percent of the 3594 individual subjects exposed to ROZEREM in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 1370 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving ROZEREM were somnolence (0.8%), dizziness (0.5%), nausea (0.3%), fatigue (0.3%), headache (0.3%), and insomnia (0.3%).
Worsening of insomnia in 3% on ramelteon versus 2% on placebo. Depression in 2% on ramelteon versus 1% on placebo.
>DRUG ABUSE AND DEPENDENCE
>ROZEREM is not a controlled substance.
This will surely increase its popularity - especially since it can be used on a long-term basis.
~Ed
Posted by ed_uk on July 24, 2005, at 7:02:24
In reply to Rozerem Information, posted by ed_uk on July 24, 2005, at 6:38:48
.....it will be the official p-babble Rozerem thread - a bit like the massive Effexor thread that's been going for YEARS! People can use this thread to post their experiences and opinions RE ramelteon. It will be a fantastic source of info. When Rozerem hits the pharmacy shelves, please post your experiences here. Many people will be interested.
~ed
Posted by ed_uk on July 24, 2005, at 8:46:38
In reply to Let's keep this thread going........., posted by ed_uk on July 24, 2005, at 7:02:24
Who's gonna be queueing (sp) up outside the pharmacy?
Who's gonna be collecting Rozerem samples?
~Ed
Posted by linkadge on July 24, 2005, at 15:09:49
In reply to OK, so who wants to try Rozerem when it comes out?, posted by ed_uk on July 24, 2005, at 8:46:38
I think I'll stick to melatonin and spare the cancer risk or whatever it was.
Linkadge
Posted by ed_uk on July 24, 2005, at 16:21:46
In reply to Re: OK, so who wants to try Rozerem when it comes out?, posted by linkadge on July 24, 2005, at 15:09:49
Oh well, it probably won't be released in Canada for a few years yet!
~Ed
Posted by ed_uk on July 24, 2005, at 16:44:36
In reply to Re: OK, so who wants to try Rozerem when it comes out? » linkadge, posted by ed_uk on July 24, 2005, at 16:21:46
Surely someone is interested in Rozerem!!!
~Ed
Posted by linkadge on July 24, 2005, at 17:02:47
In reply to Where are all the INSOMNIA sufferers???, posted by ed_uk on July 24, 2005, at 16:44:36
They're just running out of the necessary letters to create euphonic medication names.
Linkadge
Posted by linkadge on July 24, 2005, at 17:04:18
In reply to Re: Where are all the INSOMNIA sufferers???, posted by linkadge on July 24, 2005, at 17:02:47
And when Rozerem came down from the mountain, God spakeith to him saying...
Linkadge
Posted by ed_uk on July 24, 2005, at 17:06:12
In reply to Re: Where are all the INSOMNIA sufferers???, posted by linkadge on July 24, 2005, at 17:02:47
Rozerem sounds kind of euphoric, not as much as Quaalude though!
~Ed
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