The Medicines and Healthcare products Regulatory Agency (MHRA) has ordered strengthened warnings on packaging and patient information for gabapentinoids, benzodiazepines and z-drugs following a safety review. From 8 January 2026, outer packs will carry the statement ‘May cause addiction, dependence and withdrawal reactions’ to standardise risk messaging to patients and prescribers. ([gov.uk](https://www.gov.uk/government/news/mhra-strengthening-dependency-and-addiction-warnings-on-medicines-used-to-treat-pain-anxiety-and-insomnia))
According to the MHRA’s Drug Safety Update, the revised patient information leaflets will add clearer definitions of dependence and addiction, practical guidance on how to taper and stop treatment safely, and prompts for structured conversations between patients and clinicians at initiation and review. ([gov.uk](https://www.gov.uk/drug-safety-update/improving-information-supplied-with-gabapentinoids-pregabalin-slash-gabapentin-benzodiazepines-and-z-drugs))
The Commission on Human Medicines advised that the warnings be strengthened and endorsed new patient resources. These materials highlight key safety messages, including avoiding use with opioids or alcohol and not sharing prescribed medicines with others, to reduce the risk of harm. ([assets.publishing.service.gov.uk](https://assets.publishing.service.gov.uk/media/695f894044a6f04b0a5a5a82/Improving_information_supplied_with_Gabapentinoids_Benzodiazepines_Z_Drugs.pdf))
Implementation will be phased. The Drug Safety Update notes that Summary of Product Characteristics, patient leaflets and outer packaging are being updated and will be rolled out over the coming months, while the MHRA’s announcement confirms manufacturers will introduce changes over a transition period. ([gov.uk](https://www.gov.uk/drug-safety-update/improving-information-supplied-with-gabapentinoids-pregabalin-slash-gabapentin-benzodiazepines-and-z-drugs))
For prescribers, the guidance is explicit: agree an end‑of‑treatment plan before starting these medicines; use non‑judgemental language when discussing addiction and dependence; monitor for tolerance and withdrawal; and draw on NICE guideline NG215 resources and patient decision aids when planning dose reductions. ([gov.uk](https://www.gov.uk/drug-safety-update/improving-information-supplied-with-gabapentinoids-pregabalin-slash-gabapentin-benzodiazepines-and-z-drugs))
For pharmacies, the regulator has produced patient handouts for benzodiazepines, gabapentinoids and z‑drugs to be supplied at dispensing. The Drug Safety Update also signposts the Royal Pharmaceutical Society’s repeat‑prescribing toolkit to support reviews of ongoing supplies. ([gov.uk](https://www.gov.uk/drug-safety-update/improving-information-supplied-with-gabapentinoids-pregabalin-slash-gabapentin-benzodiazepines-and-z-drugs))
Scope and clinical caveats are set out in the MHRA material. Specialist uses such as epilepsy or procedural sedation were outside the review’s scope; where prescribed for epilepsy, treatment should continue as advised by the clinician. Dose reductions should be gradual and may take weeks or months depending on individual response. ([gov.uk](https://www.gov.uk/drug-safety-update/improving-information-supplied-with-gabapentinoids-pregabalin-slash-gabapentin-benzodiazepines-and-z-drugs))
The action forms part of a wider programme on dependence‑forming medicines launched after Public Health England’s 2019 evidence review. Comparable measures for opioids-pack warnings and enhanced product information-were introduced in 2020 and remain in effect. ([gov.uk](https://www.gov.uk/government/publications/prescribed-medicines-review-report))
Announcing the update, MHRA Chief Safety Officer Dr Alison Cave said “Addiction and dependency can happen to anyone taking these medicines,” urging patients not to stop suddenly and to seek professional advice if concerned. ([gov.uk](https://www.gov.uk/government/news/mhra-strengthening-dependency-and-addiction-warnings-on-medicines-used-to-treat-pain-anxiety-and-insomnia))
Suspected side effects, including dependence or withdrawal, should be reported via the MHRA Yellow Card scheme. The Public Assessment Report indicates ongoing engagement with NHS England and the Advisory Council on the Misuse of Drugs to embed consistent practice across the UK. ([gov.uk](https://www.gov.uk/drug-safety-update/improving-information-supplied-with-gabapentinoids-pregabalin-slash-gabapentin-benzodiazepines-and-z-drugs))