EMEA Publishes Draft Guidance on the Development of Medical Products for Insomnia

Full Guidance Here

The present document should be considered as general guidance on the development for medicinal products for the treatment of acute and chronic forms of insomnia. Its main focus is on primary insomnia, however, some issues on secondary or comorbid insomnia will be mentioned as well. This document should be read in conjunction with other relevant EMEA and ICH guidelines. Based on efficacy and safety data several drugs have been approved for short-term treatment of insomnia (e.g. benzodiazepines, benzodiazepine-like products, melatonin). Recent progress in basic science and current medical practice has fostered new interest in more efficacious treatment options for the short-term treatment and particularly for long-term treatment of insomnia. For regulatory purposes this requires a different approach, particularly with regard to long-term studies (patient population, study duration, choice of endpoints, risk of tolerance and dependence, etc.). Depending on the sleep disturbance (e.g. sleep onset latency or number of awakenings) studied, distinct assessment tools for clinical and neurophysiological assessments should be used, refined or newly developed. The typical design to demonstrate efficacy is a randomized, double-blind, placebo controlled, parallel group study comparing change in the primary endpoint. The results must be robust and clinically meaningful. If an indication for long-term treatment of chronic insomnia is sought, the absence of tolerance, abuse and dependency potential should be  established in addition to long-term efficacy and safety. Taking into consideration that insomnia has considerable impact on cognitive, affective and physical domains, an efficacious treatment should not be limited to improvement of all or some aspects of sleep parameters, but also produce clinically relevant improvement in daytime functioning and quality of life.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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