Established Safety with AMBIEN CR
Over 3.5 million patients treated since launch 1*
No significant decrease in performance was observed using neurocognitive tests 8 hours post dose.
- In clinical studies, there was no significant decrease in motor function or memory.2
- No evidence of next-day residual effects was detected using self-ratings of sedation.2
- Next-day somnolence was reported by 15% of the adult patients who received 12.5 mg of zolpidem vs. 2% of the placebo group. Next-day somnolence was reported by 6% of the elderly patients who received 6.25 mg of zolpidem vs. 5% of the placebo group.
AMBIEN CR has an established drug interaction profile.
- Multiple P450 pathways for metabolism means only partial clearance via the CYP3A isozyme.3
- Reduced possible interaction with other drugs that are cleared via the CYP3A isozyme.3
- No demonstrated interactions with cimetidine, ranitidine, digoxin, warfarin, and haloperidol.2†
AMBIEN CR has a favorable safety and tolerability profile.
- Adverse event profile similar to zolpidem tartrate.2,4
- The US clinical trial experience of zolpidem tartrate does not reveal any clear evidence for withdrawal syndrome.2
- In clinical trials, the most common adverse events for AMBIEN CR were headache, somnolence, and dizziness.2
AMBIEN CR is a non-narcotic, non-benzodiazepine.2
There is established clinical experience with zolpidem tartrate.1
Unpleasant aftertaste was not reported in clinical trials for AMBIEN CR.2
During short-term treatment with zolpidem tartrate, the most commonly observed adverse effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%).
* Source: WK Patient Trends Market Focus, September 2005 - January 2007
† All in multiple-dose studies except haloperidol, which was in a single-dose study and not predictive of long-term administration.
Co-administration of zolpidem 10 mg and itraconazole 200 mg resulted in a 34% increase in AUC of zolpidem. There were no significant pharmacodynamic effects of zolpidem on subjective drowsiness, postural sway, or psychomotor performance.2
Important safety information:
AMBIEN CR is indicated for the treatment of insomnia.
In elderly or debilitated patients, or patients with hepatic insufficiency, the recommended dose is 6.25 mg and patients should be closely monitored. Due to its rapid onset of action, patients should take AMBIEN CR right before going to bed and when ready for sleep.
Patients should not take AMBIEN CR unless they are prepared to get a full night's sleep (7 to 8 hours) to avoid residual effects.
Until they know how it will affect their physical or mental performance upon awakening, patients should not drive or operate hazardous machinery after taking AMBIEN CR or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, have been reported in patients who have taken a sedative hypnotic. Discontinuation of AMBIEN CR should be strongly considered for patients reporting such complex behaviors. Rare cases of angioedema have been reported in patients after taking sedative hypnotics. Patients who develop angioedema should not be rechallenged. The most commonly observed adverse effects in controlled clinical trials were headache, somnolence, and dizziness. Because individuals with a history of addiction or substance abuse are at increased risk of habituation and dependence, they should be under careful surveillance when receiving AMBIEN CR or any o ther hypnotic. AMBIEN CR is a Schedule IV controlled substance. US clinical trial experience from zolpidem does not reveal any clear evidence for withdrawal syndrome.
Please refer to the full prescribing information.
References:
1 Data on file, sanofi-aventis.
2 AMBIEN CR Prescribing Information.
3 von Moltke LL, Greenblatt DJ, Granda BW, et al. Zolpidem metabolism in vitro: responsible cytochromes chemical inhibitors, and in vivo correlations. Br J Clin Pharmacol. 1999; 48:89-97.
4 Ambien Prescribing Information.