MHRA Alert – Updated Safety Information for Gabapentinoids, Benzodiazepines and Z-Drugs
MHRA alert 8 January 2026 · Updated 3 May 2026
Source: MHRA Drug Safety Update, Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs. Read the alert itself before acting on it.
Updated Warnings on Addiction, Dependence and Withdrawal
The MHRA has completed a comprehensive review of safety information supplied with gabapentinoids (pregabalin and gabapentin), benzodiazepines, and z-drugs. The review examined warnings relating to addiction, dependence, withdrawal, and tolerance to ensure prescribers and patients have clear, consistent guidance.
Key Findings
The MHRA's Public Assessment Report details the outcomes of this review and confirms updated recommendations for how these risks should be communicated on product information and in clinical practice. This update reflects current evidence and aims to support safer prescribing and patient management.
Affected Medications
- Gabapentinoids: Gabapentin, Pregabalin
- Benzodiazepines: All benzodiazepine medications
- Z-Drugs: Zopiclone, Zolpidem, Zaleplon
What You Need to Do
Review the updated safety information for any of these medications in your clinical area. Ensure that prescribing decisions and patient counselling reflect the latest guidance on dependence risk, particularly for long-term use. Familiarise yourself with withdrawal protocols and patient support strategies.
The full Public Assessment Report and detailed guidance are available on the MHRA website.
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