The UK Medicines and Healthcare products Regulatory Agency has issued strengthened warnings about the risks of addiction, dependence, tolerance and withdrawal associated with several classes of central nervous system depressant medicines, following a safety review by the Commission on Human Medicines.
The review focused on three distinct medicine classes that act on the central nervous system, Z-drugs, gabapentinoids and benzodiazepines. Z-drugs include commonly prescribed hypnotics such as zopiclone, zolpidem and eszopiclone, while gabapentinoids include pregabalin and gabapentin. Benzodiazepines covered by the review include diazepam, lorazepam, clobazam, temazepam and nitrazepam. These medicines are widely used in conditions such as insomnia, generalised anxiety disorder and neuropathic pain.
The CHM analysis drew on Yellow Card reports and safety data submitted by marketing authorisation holders. Key themes identified included limited patient awareness of the potential for dependence and significant difficulties stopping treatment once it had been started. Over the past decade, increasing numbers of patients have been prescribed dependency-forming medicines for longer durations, raising the risk of addiction and withdrawal symptoms.
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As a result, the CHM recommended clearer and more prominent warnings on packaging and in patient information leaflets. All three medicine classes will now carry the warning, “May cause addiction, dependence, and withdrawal reactions.” Patient leaflets will also include clearer explanations of dependence and addiction, improved advice on tapering and stopping treatment safely, and encouragement for patients to discuss concerns with healthcare professionals.
The review forms part of a broader MHRA programme examining dependency-forming medicines, which began after a Public Health England evidence review published in 2019 and followed strengthened opioid warnings introduced in 2020. The CHM also called for improved professional training, particularly in deprescribing, and better strategies for supporting patients who are reluctant to discontinue long-term treatment.
Although Z-drugs were originally developed as safer alternatives to benzodiazepines, more recent evidence suggests they carry similar risks, including cognitive impairment and misuse. Rehabilitation providers have reported rising numbers of patients seeking treatment for dependence on Z-drugs, reflecting both prescribed and non-prescribed use. The MHRA said it will continue to monitor safety data and consider further regulatory action if required.
This news item has been summarised using AI and checked by humans before publication.
Sources
Medscape UK
ACNR articles
The misprescribing of Z-drugs for insomnia
Falls as a result of being on Z-drugs for insomnia
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