Insomnia Market

The Insomnia Market – An Opportunity for Growth

There is growing appreciation for the importance of sleep and its relationship to good health. We know that sleep is essential for human performance, general health, and overall well-being. Regardless of age, adults should get at least 7 to 8 hours of sleep per night. Yet, millions of people get less than this amount on either a sporadic or chronic basis. Insomnia is the most common sleep complaint across all stages of adulthood and can happen either alone or in association with other disease or disorders. It can also result from external factors such as stress or medication use. Insomnia is characterized by difficulty falling asleep, waking frequently during the night, waking up too early and being unable to return to sleep, or waking up feeling unrefreshed.

The negative health consequences of insomnia are becoming better understood. Scientific studies have shown that insomnia lasting more than four weeks is associated with a wide range of adverse conditions, including mood disturbances, depression, difficulties with concentration and memory, and certain cardiovascular, pulmonary and gastrointestinal disorders.

Even in otherwise healthy young people, sleep deprivation has been associated with early signs of aging, carbohydrate intolerance and insulin resistance. One study showed that when normal sleep was restricted by as little as two hours per night across two weeks, the affected person experienced a significant decrease in cognitive function that resulted in reaction time and other performance measures resembling those of a person who stayed up for 48 hours straight.

Historically, products for the treatment of insomnia have only addressed difficulty falling asleep and have not been particularly useful to people who either wake up frequently during the night or wake up too early and cannot return to sleep. Only recently have products become available that can help people who wake up frequently, although the ability of most currently available insomnia products to maintain sleep throughout the night without unwanted next-day residual effects remains limited.

We believe that the insomnia market is still underserved due to the limitations of currently available products. Though more than 70 million people are estimated to be affected by insomnia, one study suggests that only 10 to 12 million of those people are treated with prescription medications.

The reasons so few people seek to treat their insomnia with prescription medications are varied, but appear to frequently involve patient concerns about both the safety and efficacy of currently available drugs. The primary safety concern reported is the fear that sleep aids cause addiction and/or dependency. Patients also mentioned other undesirable side effects such as amnesia. With respect to efficacy, patients mentioned that they don’t feel that their insomnia is well controlled, which suggests a limited ability of these products to address all three major components of insomnia: sleep onset, sleep maintenance and early morning awakenings.


Patient safety concerns are largely based on the way many of the current therapies work. Many of the leading drugs approved for the treatment of insomnia act through mediation of neurotransmitters that act upon the GABA receptor complex in the central nervous system. These insomnia medications are non-selective central nervous system depressants. This may result in the risk of short-term side effects such as amnesia and longer-term safety concerns such as dependence and addiction. These products are designated by the U.S. Drug Enforcement Agency (DEA) as Schedule IV controlled substances, and their prescribing and use are carefully monitored. We believe many physicians are reluctant to prescribe, and patients are reluctant to take, scheduled drugs for chronic use in treating insomnia.

Products currently prescribed for insomnia, including antidepressants and benzodiazepines or other drugs that work via GABA modulation, can be associated with numerous other undesirable side effects, such as dry mouth, unpleasant taste, blurred vision, residual next-day effects, hormonal changes and gastrointestinal effects. We believe that drugs with improved tolerability would be well received by both physicians and patients and will have the potential to accelerate prescription growth in an already fast-growing insomnia market.

Consumers and doctors alike are looking for different options.

We believe the product profile that emerged from our clinical trials of SILENOR™ (doxepin HCl tablets) has the potential to address many of the unmet medical needs that exist in the treatment of insomnia.

Based on the results from the entire clinical development program for SILENOR™, we believe there is the potential to obtain FDA approval of SILENOR™ for the treatment of insomnia that will offer a number of features that are attractive to physicians and patients: