Reason for request
The actual benefit of this proprietary drug is low. This actual benefit is granted for 18 months, and is conditional. It is conditional on an assessment of the impact of CIRCADIN use on the consumption of hypnotics such as benzodiazepines or related substances in France; it will be re-assessed 18 months after inclusion on the list of medicines reimbursed by National Insurance, in view of the results of the follow-up study requested by the Committee (see paragraph 4.5). It will be re-assessed if a product with a higher efficacy/safety ratio in the treatment of insomnia is included on the list of medicines reimbursed by National Insurance.
Improvement in actual benefit
Given the weakness of the clinical efficacy data that have been presented, the Transparency Committee considers that CIRCADIN does not provide any improvement in actual benefit in the management of primary insomnia.