{"id":406001,"date":"2026-01-11T10:14:19","date_gmt":"2026-01-11T10:14:19","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/406001\/"},"modified":"2026-01-11T10:14:19","modified_gmt":"2026-01-11T10:14:19","slug":"tougher-mhra-addiction-warnings-for-z-drugs","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/406001\/","title":{"rendered":"Tougher MHRA Addiction Warnings for Z-Drugs"},"content":{"rendered":"

The Medicines and Healthcare products Regulatory Agency (MHRA) has\u00a0strengthened warnings\u00a0<\/a>about the risks of dependence, addiction<\/a>, withdrawal, and tolerance linked to several classes of central nervous system (CNS) depressant medicines.<\/p>\n

The move follows a safety review by the Commission on Human Medicines (CHM), an independent expert advisory body. Rehabilitation experts said they are treating rising numbers of people with addiction to so-called Z-drugs, including zopiclone, zolpidem<\/a>, and eszopiclone<\/a>.<\/p>\n

In a new public assessment report, the MHRA said Z-drugs, gabapentinoids \u2014 including pregabalin<\/a> and gabapentin<\/a> \u2014 and benzodiazepines, such as diazepam<\/a>, lorazepam<\/a>, clobazam<\/a>, temazepam<\/a>, and nitrazepam, are three distinct classes of medicines that act on the CNS.<\/p>\n

These drugs are commonly prescribed for conditions such as neuropathic pain, generalised anxiety disorder<\/a>, and insomnia<\/a>.<\/p>\n

The review identified key themes from Yellow Card reports and data submitted by marketing authorisation holders. These included poor patient awareness of dependence risks and difficulties stopping treatment once started.<\/p>\n

The CHM recommended stronger warnings on packaging and patient information leaflets for gabapentinoids, benzodiazepines, and Z-drugs to better inform patients and healthcare professionals about the risks.<\/p>\n

The review followed the MHRA\u2019s decision in September 2020 to strengthen warnings on opioid pain medicines <\/a>and formed part of a wider programme examining dependency-forming drugs. That programme was launched in response to a Public Health England evidence review <\/a>published in September 2019.\u00a0<\/p>\n

More Patients Taking Medicines for Longer<\/p>\n

The CHM review found that, over the past decade, increasing numbers of patients have been prescribed dependency-forming medicines for longer periods, increasing the risk of addiction and difficulties stopping treatment.<\/p>\n

The committee recommended the development of new patient resources to highlight key safety messages. These include warnings not to use these medicines alongside opioids or alcohol, and advice not to share prescribed medicines with others.\u00a0<\/p>\n

In September 2020, the MHRA also issued specific advice to healthcare professionals, warning that long-term opioid use \u2014 defined as more than 3 months \u2014 for non-cancer pain is associated with an increased risk of dependence and addiction.<\/p>\n

The CHM also recommended additional support and resources for professional training. It emphasised the need to improve deprescribing skills among healthcare professionals and to develop better approaches to engaging patients who are reluctant to discontinue treatment.<\/p>\n

Safer Alternatives Proved Disappointing<\/p>\n

Benzodiazepines were introduced in the 1960s as a safer alternative to barbiturates, which carried a high risk of overdose. However, traditional benzodiazepines such as diazepam proved to have a significant potential for dependence and misuse.<\/p>\n

Z-drugs were developed as a further alternative and act on the same brain receptors, initially thought to offer safety advantages.<\/p>\n

However, an independent review published in 2023\u00a0<\/a>reported that both benzodiazepines and Z-drugs are associated with similar adverse effects, including drowsiness, dizziness, and cognitive impairment. The review also reported an increased risk of dementia in older adults.\u00a0<\/p>\n

While prescribing trends show a decline in benzodiazepine prescriptions and an increase in Z-drug prescribing, evidence suggests Z-drugs carry comparable risks of adverse effects and addiction.<\/p>\n

Rehab Provider Reports Growing Misuse<\/p>\n

According to private rehabilitation provider Liberty House<\/a>, Z-drugs are increasingly being treated as substances of misuse, both following prescribed use and through recreational abuse.<\/p>\n

The provider said this reflects overprescribing and misplaced confidence in their safety, and that its clinics are seeing more patients seeking treatment for dependence linked to their sedative<\/a> and euphoric effects.<\/p>\n

The clinic reports treating growing numbers of patients for dependence on medications including zolpidem (Ambien) and eszopiclone (Lunesta).<\/p>\n

Who Is At Risk?<\/p>\n

According to rehabilitation providers, factors that increase the risk of developing dependence on Z-drugs include:<\/p>\n

A family history of addictionTaking Z-drugs other than as prescribedRecreational use of Z-drugsSelf-medicating for untreated mental health conditionsA history of trauma which leads to Z-drug abuse<\/a> to deal with difficult memories and emotionsEasy access to Z-drugs through friends or family members with prescriptions<\/p>\n

The MHRA said all three classes of medicine will now carry the warning: \u201cMay cause addiction, dependence, and withdrawal reactions.\u201d<\/p>\n

Patient information leaflets will include clearer definitions of dependence and addiction, improved guidance on tapering and stopping treatment safely, and information to encourage discussions between patients and healthcare professionals.<\/p>\n

The agency said it will continue to monitor the safety of these medicines and take further regulatory action if necessary.<\/p>\n

Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"The Medicines and Healthcare products Regulatory Agency (MHRA) has\u00a0strengthened warnings\u00a0about the risks of dependence, addiction, withdrawal, and tolerance…\n","protected":false},"author":2,"featured_media":406002,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[215244,6116,5011,88052,64,63,131391,215241,215243,29323,50967,215237,137,215240,215236,490,212534,15436,11742,215242,29561,5012,5429,12744,3586,215238,215239],"class_list":["post-406001","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-acute-pain","tag-addiction","tag-adverse-effects","tag-anxiety-disorder","tag-au","tag-australia","tag-benzodiazepines","tag-cancer-pain","tag-cancer-related-pain","tag-cognitive-impairment","tag-drug-abuse","tag-eszopiclone","tag-health","tag-hypnotic","tag-hypnotic-drug","tag-medication","tag-neuropathic-pain","tag-opioids","tag-pain","tag-pain-from-cancer","tag-pain-management","tag-side-effects","tag-uk","tag-uk-site-content-united-kingdom-site-content","tag-united-kingdom","tag-zaleplon","tag-zolpidem"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/406001","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=406001"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/406001\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/406002"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=406001"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=406001"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=406001"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}