Abstract
Insomnia is trouble sleeping or maintaining sleep and feeling unrested after sleeping. Commonly used conventional treatments for insomnia include melatonin, anti-histamines, L-tryptophan and magnesium. The sale of complementary medicines (CMs) for treating a range of ailments (including insomnia) is prevalent. CMs are required to adhere to specific regulatory requirements to continue to be sold, including labelling, advertising and correct categorization of the product and risk classification of the product’s intended use in line with prescribed legislation and guidance from the South African Health Products Regulatory Authority (SAHPRA). The extent to which CMs indicated for insomnia and available for sale in South Africa are compliant with the standard regulatory requirements has not yet been investigated.
The aim of this study was to review the formulation, classification of clinical indications and labelling compliance of complementary medicines for insomnia on the South African market by comparing the products available for sale to applicable legislation, SAHPRA guidelines as well as recognized monographs and scientific sources.
This non-experimental study consisted of a descriptive design and quantitative endpoint with the review and evaluation of the extent of regulatory compliance of specified CMs indicated for insomnia in the South African market. A total of 35 complementary medicines indicated for insomnia were included in the study. Labels of all included products were reviewed for compliance. Products were identified and documented and then products that met the inclusion criteria were on a separate document which was coded for identification of the product. The General Regulations made in terms of the Medicines and Related Substances Act, 1965 (Act 101 of1965), as well as SAHPRA guidelines were used as a reference for comparing product compliance, EMA monographs were used to assess herbal ingredient use, and Annexures to SAHPRA Guideline 7.04 used to assess the intended health supplement ingredients.
None of the products complied entirely with all labelling requirements relevant to immediate outer labels, professional information and patient information leaflets. Compliance with regulatory standards is essential to ensure the safe use of products by the end-user. While regulatory compliance is evident, all stakeholders must ensure continued efforts at implementing the minimum regulatory requirements to assure the safety, quality and efficacy of the CMs in South Africa.