Zolpidem Tartrate (Controlled Release Ambien)

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On March 14, 2007, the U.S. Food and Drug Administration (FDA) announced a class labeling change for all prescription sedative-hypnotic medications indicated for the treatment of insomnia. Additionally, the FDA has requested each manufacturer to develop a Dear Healthcare Professional Letter (DHCPL) and a Medication Guide.

US Prescribing Information

Dear Healthcare Professional Letter

A Good Night's Sleep from Start to Finish

Prescribe Dual-Layer AMBIEN CR First Line for Both Sleep Induction and Sleep Maintenance.

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Wake-up ready for the day.
Immediate release for fast onset.
Extended release for prolonged plasma concentrations.
Proven 2.8-hour half-life helps limit drug activity to sleeping hours.
One dose of 12.5 mg for nonelderly adults.

For over a decade, zolpidem tartrate has been helping millions of people get the sleep they need. Now, AMBIEN CR delivers the molecule you know in a dual-layer design.²

The dual-layer design of AMBIEN CR provides immediate release for the fast onset of sleep and controlled release for sleep maintenance.
Its controlled-release design provides prolonged plasma concentrations during the night. And the favorable 2.8-hour half-life of AMBIEN CR helps limit drug activity to sleeping hours.¹
The result is improved sleep maintenance with fewer disruptions in your adult* patients, so they can wake up ready for a new day.

*Sleep maintenance results vary for patients 65 years of age and older..

And AMBIEN CR:

is not limited to the short-term treatment of insomnia.¹
is a non-narcotic, non-benzodiazepine.¹
produced no reported unpleasant aftertaste in clinical trials.¹

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.

AMBIEN is indicated for the short-term treatment of insomnia.

Important Safety Information

When you first start taking AMBIEN, use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication. In most instances, memory problems can be avoided if you take AMBIEN only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. As with any sleep medication, do not use alcohol while you are taking AMBIEN.

Sleepwalking, and eating or driving while not fully awake, with amnesia for the event, have been reported. If you experience any of these behaviors contact your provider immediately. In rare cases, sleep medicines may cause allergic reactions such as swelling of your tongue or throat, shortness of breath or more severe results. If you have an allergic reaction while using AMBIEN, contact your doctor immediately.

Prescription sleep aids are often taken for 7 to 10 days – or longer as advised by your provider. Like most sleep medicines, it has some risk of dependency.

There is a low occurrence of side effects associated with the short-term use of AMBIEN. The most commonly observed side effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%).

Please see additional important information. Please refer to the full prescribing information.

Reference:

1 AMBIEN CR Prescribing Information.
2 Zolpidem tartrate worldwide. (Based on IMS data 1988-2004)