Getting Back to Sleep

by pharmacy on January 11, 2012

Recently, the FDA approved a new drug with a unique function. It’s designed to treat a very specific type of insomnia, where the sufferer wakes in the middle of the night and can’t get back to sleep. Intermezzo (zolpidem tartrate sublingual tablets), a drug manufactured by made by Transcept Pharmaceuticals Inc. of Port Richmond, California, is basically a fast-acting lower dose of Ambien. It is only recommended if there are four or more hours of possible sleep time. Taking the sleep aid with less time remaining for sleep could result in extreme grogginess during the day.

Insomnia is a very common condition, and prolonged sleep deprivation can be a serious threat to health. Insomnia can be temporary or long term and can include trouble falling asleep and trouble staying asleep. Sleeplessness has a wide range of effects, from trouble concentrating to anxiety, depression, irritability, and lack of energy. Prolonged insomnia can have severe consequences.

The efficacy of the drug was tested in clinical trials with more than 370 participants. The trials proved that patients taking Intermezzo fell back to sleep after waking in less time than patients taking a placebo. Some side effects were noted, similar to other sleep aids, including headache, nausea, and fatigue. One of the more serious concerns with sleep aids is akin to sleep-walking. Getting out of bed asleep or not fully awake and performing normal activities like driving a car or cooking food that could be dangerous. These types of activities are more common when sleep medicines are combined with other medications or with alcohol.

Like Ambien, Intermezzo is considered a controlled substance because it can be addictive and can be abused. The FDA has refused to approve the drug twice in the past due to safety concerns. A number of studies have shown that the drug impairs driving ability, and that some people recover more quickly than others. The manufacturer responded to FDA concerns by adding a warning to the label that the drug should not be taken unless four or more hours of sleep time remain, that people who take Intermezzo should not attempt to drive for at least one hour after waking, and at least five hours after taking the drug, and that the drug should not be taken with alcohol or other sleep aids.

While I have no doubt that there are many people with chronic sleep problems who will benefit from this drug, I can’t help but wonder…how much is too much? Do we need to depend on drugs to address every possible problem, or should we look for less dangerous solutions? Not so long ago, mom would have prescribed a nice glass of warm milk and perhaps a half hour of relaxation techniques to clear the mind of the detritus of the day and encourage a good night’s sleep. Have we, as a society, forgotten the age-old remedies that once soothed us to sleep? Is it preferable to use a controlled substance than to take a hot bath and have a glass of wine? You tell me.

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