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Warnings on the risk of dependency and addiction for gabapentinoids, benzodiazepines and z-drugs are to be strengthened, following a safety review by the medicines regulator.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced on 8 January 2026 that packaging and patient information leaflets for the drugs would be updated to include the warning “may cause addiction, dependence and withdrawal reactions”.
“Patient information leaflets will include clearer definitions of dependence and addiction, improved guidance on how to safely taper and stop use, and information to encourage conversations between patients and healthcare professionals during their treatment,” the regulator said.
Gabapentinoids, benzodiazepines and z-drugs are commonly used in the treatment of neuropathic pain, anxiety and insomnia and have known risks of addiction, dependency, withdrawal and tolerance.
Owing to these risks, the MHRA reviewed awareness and understanding of the drugs to identify whether improvements to information supplied with them were needed.
The regulator conducted the review using data from the Yellow Card reporting scheme, manufacturers, international regulators, GP practices and patient accounts. It then presented the evidence to the Commission on Human Medicines (CHM), which was asked to provide advice and recommendations.
“Overall, it was considered that the current wording contained within the product information and labelling of gabapentinoids, benzodiazepines and z-drugs did not sufficiently communicate the extent of the known risks of addiction, dependence, withdrawal and tolerance associated with these medications,” the regulator said.
The CHM concluded that improved wording was needed to “reflect the post-marketing experience”, so that patients could be informed about the risks before starting a medicine and supported to stop medicines appropriately.
“Additionally, further support from other healthcare stakeholders will be sought in order to influence clinical guidelines and clinical practice which extends beyond the scope of the Agency,” the MHRA said.
Amira Guirguis, chief scientist at the Royal Pharmaceutical Society, said the updated warnings “are an important step in ensuring that patients and healthcare professionals are fully informed about the potential risks associated with gabapentinoids, benzodiazepines, and Z-drugs.
“These updates help ensure that patients are informed about known risks before starting treatment and are supported to stop their medication safely where appropriate. Clearer guidance on dependence, addiction, withdrawal, and tolerance supports safer prescribing, and gives patients the information they need to discuss their treatment with confidence.”
“Pharmacists and other healthcare professionals must continue to review and monitor the use of these medicines regularly, and work closely with patients to manage risks, particularly when tapering or stopping treatment,” she added.
In April 2025, an analysis of prevention of future death reports found that repeat prescription opioids were most commonly linked to patient harm and medicine-related deaths.
A review published in August 2024 found that almost one in ten people with chronic non-cancer-related pain experience opioid dependence or opioid use disorder.
