Posted by deuce224 on June 17, 2007, at 1:12:16
In reply to Re: Rozerem hangover » deuce224, posted by Quintal on June 16, 2007, at 18:36:56
> I've heard of other people saying similar things like "Felt like a slug the next day" etc. Natural melatnonin doesn't seem to have these effects at recommended doses but it's not safe to take with MAOIs unfortunately. Could you ask your doctor for Ambien, Lunesta or some other hypnotic benzo?
>
> Q
I'm pretty sure there is no known interaction between rozerem and MAOI's:
Drug Interactions
ROZEREM has a highly variable intersubject pharmacokinetic profile (approximately
100% coefficient of variation in Cmax and AUC). As noted above,
CYP1A2 is the major isozyme involved in the metabolism of ROZEREM; the
CYP2C subfamily and CYP3A4 isozymes are also involved to a minor degree.
Effects of Other Drugs on ROZEREM Metabolism
Fluvoxamine (strong CYP1A2 inhibitor): When fluvoxamine 100 mg twice
daily was administered for 3 days prior to single-dose co-administration of
ROZEREM 16mg and fluvoxamine, the AUC0-inf for ramelteon increased
approximately 190-fold, and the Cmax increased approximately 70-fold, compared
to ROZEREM administered alone. ROZEREM should not be used in combination
with fluvoxamine (see WARNINGS). Other less strong CYP1A2 inhibitors have
not been adequately studied. ROZEREM should be administered with caution
to patients taking less strong CYP1A2 inhibitors.
Rifampin (strong CYP enzyme inducer): Administration of rifampin 600 mg
once daily for 11 days resulted in a mean decrease of approximately 80%
(40% to 90%) in total exposure to ramelteon and metabolite M-II, (both
AUC0-inf and Cmax) after a single 32 mg dose of ROZEREM. Efficacy may be
reduced when ROZEREM is used in combination with strong CYP enzyme
inducers such as rifampin.
Ketoconazole (strong CYP3A4 inhibitor): The AUC0-inf and Cmax of ramelteon
increased by approximately 84% and 36%, respectively, when a single 16 mg
dose of ROZEREM was administered on the fourth day of ketoconazole 200 mg
twice daily administration, compared to administration of ROZEREM alone.
Similar increases were seen in M-II pharmacokinetic variables. ROZEREM should
be administered with caution in subjects taking strong CYP3A4 inhibitors such
as ketoconazole.
Fluconazole (strong CYP2C9 inhibitor): The total and peak systemic exposure
(AUC0-inf and Cmax) of ramelteon after a single 16 mg dose of ROZEREM was
increased by approximately 150% when administered with fluconazole. Similar
increases were also seen in M-II exposure. ROZEREM should be administered
with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole.
Interaction studies of concomitant administration of ROZEREM with fluoxetine
(CYP2D6 inhibitor), omeprazole (CYP1A2 inducer/CYP2C19 inhibitor), theophylline
(CYP1A2 substrate), and dextromethorphan (CYP2D6 substrate) did
not produce clinically meaningful changes in either peak or total exposures to
ramelteon or the M-II metabolite.
Effects of ROZEREM on Metabolism of Other Drugs
Concomitant administration of ROZEREM with omeprazole (CYP2C19 substrate),
dextromethorphan (CYP2D6 substrate), midazolam (CYP3A4 substrate), theophylline
(CYP1A2 substrate), digoxin (p-glycoprotein substrate), and warfarin
(CYP2C9 [S]/CYP1A2 [R] substrate) did not produce clinically meaningful
changes in peak and total exposures to these drugs.
Effect of Alcohol on ROZEREM
Alcohol: With single-dose, daytime co-administration of ROZEREM 32 mg and
alcohol (0.6 g/kg), there were no clinically meaningful or statistically significant
effects on peak or total exposure to ROZEREM. However, an additive effect was
seen on some measures of psychomotor performance (i.e., the Digit Symbol
Substitution Test, the Psychomotor Vigilance Task Test, and a Visual Analog
Scale of sedation) at some post-dose time points. No additive effect was seen on
the Delayed Word Recognition Test. Because alcohol by itself impairs performance,
and the intended effect of ROZEREM is to promote sleep, patients
should be cautioned not to consume alcohol when using ROZEREM.
poster:deuce224
thread:763562
URL: http://www.dr-bob.org/babble/20070613/msgs/763667.html