Development of New Therapeutical Agents for Treatment of Insomnia and Other Sleeps Disorders

Abstract

The development of a new therapeutic agent for human use is a complex, highly regulated, risky, and expensive process which, in the case of insomnia and other sleep disorders, presents some special challenges typical of this group of diseases. The development of a new therapeutic agent consists of a series of Nonclinical and clinical phases in which the new drug candidate has to demonstrate, among other things, a favorable benefit/risk ratio in the treatment of a given disease before receiving market authorization and be used to treat patients. In the Nonclinical development phase chemical development, formulation development, analytical methods development, pharmacology development, pharmacokinetic development, and Nonclinical safety evaluation of the new drug candidate are carried out. The main goal of these studies, conducted both in vitro and in vivo in laboratory animals, is to collect sufficient information to authorize the evaluation of the new therapeutic agent in humans. The clinical development phase of a new therapeutic agent consists of several steps in which the new drug candidate is administered to humans in a stepwise progression starting with administration to a reduced number of healthy volunteers and then progressing to patients in order to assess its safety and efficacy. In addition, in the case of hypnotics, specific points of concerns such as development of tolerance, potential for drug abuse, interaction with other drugs, and next-day performance should also be addressed and evaluated promptly and properly. Several guidelines issued by regulatory agencies are available to guide investigators throughout the entire development process and should be consulted to correctly design and execute the individual studies of the development plan. Nevertheless, during the development of new therapeutic agents for insomnia and other sleep disorders, specific issues can arise which are not covered by the available guidelines. Therefore, it is always highly advisable to consult with regulatory agencies on how to address these specific points. A better understanding on the drug regulatory framework and rules can maximize the chances of a successful development of a new therapeutic agent for treatment of insomnia and other sleep disorders.