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FDA Approves New Form of Ambien for Sleep Disorders

Posted by floriza in Sleep Disorders

In November, 2011, the Federal Drug Administration approved a new form of Ambien (zolpidem tartrate) for insomnia sleep disorders. The drug is being manufactured by Transcept Pharmaceuticals in Port Richmond, California under a new brand name called Intermezzo and is primarily for people who awaken during the night and have trouble getting back to sleep.

The FDA approved the new formulation in low doses at 1.75 mg for women and 3.5 mg for men. (It appears to remain in a woman’s body longer than in a man’s.) The medication is supposed to be taken no more than once each night. Ambien is usually recommended in a dose of 10 mg.

Zolpidem Safer For Some Patients

The FDA believes this new formulation of zolpidem will be safer than Ambien for people who awaken during the night. With higher doses, people are at risk of awakening with the medication remaining in their system, causing drowsiness that could make working or driving hazardous.

To make its determination, the FDA evaluated the results of two clinical trials that included a total of 370 participants. Those patients who took the low dose of zolpidem reported that they were able to get back to sleep sooner after they awakened during the night.

Some side effects were also reported, however, such as fatigue, nausea, and headaches.

What is Insomnia?

People tend to think of insomnia as simply difficulty getting to sleep, but it also includes difficulty in staying asleep. One-third of adults are estimated to suffer from insomnia at some point, and some of them experience chronic insomnia over the course of their lives.

Unfortunately, many people don’t realize that there are a host of treatments available for insomnia and other sleep disorders. While medications like Ambien and Intermezzo can be very helpful for many people, non-drug treatments for sleep disorders also work for a number of patients.

In order to diagnose someone with a sleep disorder, a physician or healthcare practitioner makes note of the patient’s sleep patterns, physical condition, job hours, travel history, medical history, mental condition (including stressors) exercise habits, and foods and other substances (such as medications and/or alcohol) that are ingested regularly. Sometimes, adjustments can be made that will alleviate the problem without the need for sleep medications.

Relaxation techniques or advice about diet and exercise are also often recommended to alleviate sleep disorders. Treatments for sleep disorders in New Jersey, New York, and beyond are available in sleep disorders centers and other medical facilities.

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