DCSIMG
Sleep Onset and Sleep Maintenance

Sleep Onset & Maintenance

For falling asleep and staying asleep

AMBIEN CR is the only formulation of zolpidem tartrate that is FDA approved for sleep onset and sleep maintenance.4,6

Subjects stayed asleep — significantly fewer awakenings 10*

In a traffic noise model of insomnia, AMBIEN CR significantly reduced number of awakenings vs. zolpidem tartrate and placebo in healthy subjects.10*

NUMBER OF AWAKENINGS

N=36

*Clinical significance of findings in healthy subjects has not been established.

P=0.0005 vs placebo; P=0.0021 vs. zolpidem immediate release (IR).

§ Effects of AMBIEN CR 12.5 mg and zolpidem IR10 mg on the total number of nocturnal awakenings in a phase I, crossover trial using a traffic noise model of insomnia.

Fall asleep faster

With AMBIEN CR, subjects fell back to sleep faster after middle-of-the-night awakenings vs. zolpidem tartrate.11

In a sleep disturbance noise model with scheduled awakenings in healthy subjects, AMBIEN CR significantly reduced latency to persistent sleep vs. zolpidem tartrate at Hours 4 (P=0.0373) and 5 (P=0.0096) postdose.11

AMBIEN CR effectiveness beyond 3 hours postdose

These studies support the enhanced pharmacologic activity of AMBIEN CR beyond 3 hours postdose, the time during which plasma concentrations remain at higher levels than immediate-release zolpidem.7


Next: Chronic Insomnia & Sleep-Related Next-Day Function

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* Maximum benefit is $240 off, up to $20 off each prescription (up to 12 prescriptions), depending on your out-of-pocket costs. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, or any private payor in the state of Massachusetts and where prohibited by law.

AMBIEN CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

AMBIEN® (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

IMPORTANT SAFETY INFORMATION

In elderly or debilitated patients, or in patients with hepatic insufficiency or dysfunction, the recommended dose of AMBIEN CR is 6.25 mg and the recommended dose of AMBIEN is 5 mg. These patients should be closely monitored.

AMBIEN CR and AMBIEN both have rapid onset of action; therefore, patients should ingest right before going to bed and when ready for sleep. To avoid residual effects, patients should not take AMBIEN CR or AMBIEN unless they are prepared to get a full night’s sleep (7 to 8 hours). 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, AMBIEN, or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, as well as abnormal behaviors such as being more outgoing or aggressive than normal, confusion, agitation, and hallucinations may occur. AMBIEN CR or AMBIEN should not be taken with alcohol as they may increase these abnormal behaviors. Discontinuation of AMBIEN CR or AMBIEN should be strongly considered for patients reporting such complex behaviors. Angioedema may occur in patients taking AMBIEN CR or AMBIEN and in rare cases may be fatal. Patients who develop angioedema should not be rechallenged. In primarily depressed patients, worsening of depression, including risk of suicidal thoughts or actions, including completed suicides, have been reported. The most commonly observed adverse effects in controlled clinical trials of AMBIEN CR were headache, somnolence, and dizziness. During short-term treatment with AMBIEN, the most commonly observed adverse effects in controlled clinical trials were drowsiness, dizziness, and diarrhea. 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, AMBIEN, or any other hypnotic. Both AMBIEN CR and AMBIEN are Schedule IV controlled substances. Sedative hypnotics have produced withdrawal symptoms following abrupt discontinuation.

Please refer to the full prescribing information for AMBIEN CR.

Please refer to the full prescribing information for AMBIEN.