Insomnia Overview

Sleep is essential for human performance, general health and well-being. Insomnia, the most common sleep complaint across all stages of adulthood, is a condition characterized by difficulty falling asleep, waking frequently during the night or too early, or waking up feeling unrefreshed. Approximately 70 million Americans have insomnia according to the National Sleep Foundation (NSF).  About 40 million people in the United States suffer from chronic sleep disorders and an additional 20-30 million are affected by intermittent sleep related disorders.  According to the 2007 Sleep in America Poll, 65% of respondents reported experiencing insomnia symptoms a few nights a week.

Patients with insomnia report a variety of sleep difficulties. In the 2007 Sleep in America Poll, 71% of respondents with insomnia often experienced awakenings during the night and waking up too early without being able to go back to sleep (sleep maintenance), and 26% had difficulty falling asleep (sleep onset). Historically, insomnia therapies have addressed sleep onset rather than sleep maintenance and duration. Only recently have therapies been approved for treating patients who suffer predominantly from sleep maintenance insomnia. The only products to demonstrate utility in treating sleep maintenance work by binding to and activating a set of brain receptors known as GABA receptors. These products carry the risk of numerous unwanted side effects, such as hallucinations, amnesia, complex sleep behaviors (i.e., sleep driving, sleep eating), dependency and next day residual sedation.  

On average, people need 7 to 8 hours of sleep per night, yet the average nightly sleep duration of a working American on a typical workday is 6 ½ hours, with many millions sleeping between 5 and 6 hours. It is established that chronic insufficient sleep leads to deterioration of mood, lack of motivation, fatigue, malaise and decrease in energy, attention and concentration.  In addition to the decrease in feelings of well-being, chronic insomnia can have serious health consequences, as it has been associated with, and may even lead to, the development of anxiety, depression, obesity, diabetes and even some types of cardiovascular disease. In fact, a 22-year follow up study of more than 20,000 twins revealed that getting less than 7 hours of sleep per night increases the risk of mortality by a staggering 21 to 26%.

Current prescription treatments for insomnia, namely the GABA receptor modulators, are limited in their ability to promote a full night's sleep without next day sedation. Our market research indicates that less than one third of patients being treated for insomnia with prescription medications claimed they were very satisfied with their current treatment, and only 12% of patients claimed that their insomnia was well controlled. The primary reason cited by insomniacs was that they did not achieve the desired 7-8 hours of sleep.

In addition, GABA receptor modulators carry the potential to induce euphoria, physical and psychological dependence, withdrawal symptoms and other unwanted side effects. In our market research, insomnia patients reported concerns with the safety and side effect profile of sleep medications. For example, almost one-third of patients claimed they woke feeling groggy, and 33% claimed to have suffered from memory impairment at some time after taking medication, with almost 80% reporting that they found memory lapse somewhat or very scary. Additionally, 24% of patients on prescription insomnia medication claimed that they were dependent on their medication and could not sleep without it. 

Only about 20 percent of those who suffer from insomnia are on prescription therapy. The strongest concern voiced by patients not on a prescription therapy is the potential for addiction and/or habituation with current prescription treatments. In our market research, 28% of people suffering from insomnia cited fear of addiction as the reason they did not seek prescription treatment, which was the most cited reason. Almost 10% of respondents suggested they do not use prescription treatments because they are worried about safety issues. Many of those people take over-the-counter (OTC) medication in an attempt to help them sleep. However, in our market research almost one-third of patients claimed their OTC medication did not work for them and 25% claimed that they woke feeling groggy.  

When we asked consumers their most favored prescription insomnia treatment attributes, the leading responses included:

· the ability to have a full night's sleep, defined as 7 to 8 hours,

· to wake feeling refreshed without next day residual sedation,

· the ability to take the product over long periods of time without the risk of dependency, and

· the removal or limitation of concerns about side effects.

These consumers also indicated a lack of brand loyalty and an inclination to try newer medications that deliver these attributes.

We believe that the clinical profile of Silenor® (doxepin) can address each of these concerns.  When presented with the Silenor clinical profile in one of our market research studies, all participants indicated a willingness to try Silenor.  In addition, when these participants were asked to rate whether the product met all of their desired characteristics for the treatment of insomnia, 90% of them rated Silenor either a 9 or 10 on a ten point scale.

Insomnia remains an under-diagnosed and under-treated disorder. The current situation provides an opportunity for a product with the clinical profile of Silenor to fill an unmet need.  There is an opportunity to heighten awareness among physicians and patients about the connection between sleep and health and the costs associated with not getting adequate sleep. Silenor's ability to deliver 7-8 hours of sleep, and in particular its ability to prevent awakenings in the final hours of the night, meets that need. There is also a significant opportunity to provide insomnia patients with an efficacious therapy that is devoid of the troublesome side effects such as hallucinations, amnesia, complex sleep behaviors and the risk that these medications are habit forming.