FDA Approves Silenor for Insomnia

The makers of sleeping pills such as Ambien, Lunesta and Rozerem will soon have new competition. On March 17 the FDA granted approval to Somaxon Pharmaceuticals for its drug Silenor. Somaxon reports that the insomnia medication should be available in the second half of 2010.

But Silenor isn’t for people who have trouble falling asleep. It takes about 3.5 hours for the drug to reach its peak concentration in the blood.

So the FDA approved Silenor to help people who struggle with “sleep maintenance.” It may benefit people who tend to wake up during the night or early in the morning and struggle to return to sleep.

The drug that Silenor contains is called “doxepin.” For years this histamine-blocking drug has been used at high doses as an antidepressant.

It has been known that doxepin also improves sleep. But at high doses it may cause severe side effects. This prevented the drug from being used as a common sleep aid.

Now studies have shown that doxepin can reduce the symptoms of insomnia at doses as low as 3mg or 6 mg. Side effects are minimal at these low doses. The FDA recommends that older adults start with the 3 mg dose.

One of these studies was published in the journal Sleep in 2007. It involved 66 adults with chronic primary insomnia. They had a mean age of 42 years, and 70 percent were women. Both 3 mg and 6 mg doses of doxepin were compared with a placebo.

Results show that doxepin reduced the time spent awake after falling asleep by about 22 to 23 minutes. It increased total sleep time by about 26 to 29 minutes. But it did not reduce the number of awakenings during the night.

Last year the Sleep Education Blog reported an increase in prescriptions for sleeping pills. The use of sleeping pills by young adults also rose dramatically.

The AASM offers these Guidelines for Taking Sleep Medications. Contact your doctor or pharmacist if you have any other questions about taking sleeping pills.

You also should ask your doctor about cognitive behavioral therapy for insomnia. It is a safe and effective treatment option.

Get help for insomnia at an AASM-accredited sleep center near you.