AMBIEN CR Prolongs Plasma Concentrations During the Night.1
AMBIEN CR provides greater plasma concentrations beyond 3 hours after administration compared to zolpidem tartrate 10 mg2*
And AMBIEN CR has a favorable half-life of 2.8 hours, similar to zolpidem tartrate.1,3
Mean Plasma Concentration1,2
Constants
(Yellow) Ambien CR (zolpidum tartrate extended release) 12.5mg
(Blue) Zolpidem tartrate 10 mg immediate release
(x axis, 0-8 by .5) Time (hours)
(y axis, 0-120, by 10) Zolpidem plasma concentration (ng/ml)
Flash
Stage 1: Fast Onset: The first layer provides immediate release for fast onset.
Stage 2: Continued Delivery: The second layer provides controlled release for prolonged plasma concentrations.
Stage 3: Metabolized by Morning: The proven half-life helps limit drug activity to sleeping hours.
* Results of a randomized open, crossover study in 24 healthy adults.2
Pharmacokinetics1
AMBIEN CR exhibits biphasic absorption characteristics, which result in rapid initial absorption from the gastrointestinal tract, similar to zolpidem tartrate immediate-release, then provides extended plasma concentrations beyond 3 hours after administration.
A study in 24 healthy male subjects was conducted to compare mean zolpidem plasma concentration-time profiles obtained after single oral administration of AMBIEN CR (12.5 mg) and of an immediate-release formulation of zolpidem tartrate (10 mg). The terminal elimination half-life observed with AMBIEN CR (12.5 mg) was similar to that obtained with immediate-release zolpidem tartrate (10 mg).
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 AMBIEN CR Prescribing Information.
2 Data on file, sanofi-aventis.
3 AMBIEN Prescribing Information.