The UK's medicines watchdog is taking decisive action to highlight the risks of addiction and dependency linked to a range of widely prescribed drugs for pain, anxiety, and insomnia. The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that patient information leaflets for gabapentinoids, benzodiazepines, and Z-drugs will now carry significantly strengthened warnings.
Which Drugs Are Affected by the New Warnings?
The safety review focused on three major classes of medication. Gabapentinoids, including gabapentin and pregabalin, are primarily used for nerve pain and epilepsy but are also prescribed 'off-label'. NHS data from 2022/2023 shows an estimated 4.5 million people in England alone were prescribed gabapentinoids during that period. It is believed around 800,000 people in the UK take pregabalin daily.
Benzodiazepines, such as diazepam, lorazepam, and temazepam, are typically issued by GPs for short-term crisis management of severe anxiety or insomnia, usually for two to four weeks. These are distinct from Z-drugs like zopiclone and zolpidem, which are prescribed for short-term severe insomnia.
What Will the New Warnings Say?
Following the recent review, the Commission on Human Medicines (CHM) recommended critical updates to product information. The patient leaflets will now prominently state that these medicines 'may cause addiction, dependence, and withdrawal reactions'.
The updated guidance will also provide:
- Clearer definitions of dependence and addiction.
- Improved advice on how to safely taper and stop using the medication.
- Information to encourage ongoing conversations between patients and healthcare professionals.
- Additional warnings against using these medicines with opioids or alcohol, and against sharing medication.
The Real-World Impact of Dependency
The move comes amid growing recognition of the physical dependency these drugs can cause. Some users of gabapentinoids report needing ever-higher doses to feel the effects, with some resorting to buying extra tablets online or from street dealers. A significant percentage of those on daily pregabalin fear they may never be able to stop due to physical dependence.
Dr Alison Cave, MHRA Chief Safety Officer, emphasised: 'Addiction and dependency can happen to anyone taking these medicines, even when used as directed. That's why we are strengthening warnings so patients and healthcare professionals can better understand the risks.'
She added: 'These medicines remain valuable treatments for many patients and it's important they have the information they need to use them safely. Do not stop taking your medicine without advice, as this could cause withdrawal symptoms.'
