Alison Comyn (Fianna Fail)
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Everyone may be experiencing what I will describe for very different reasons. Imagine lying awake at night, tossing and turning and unable to switch off. The room is too warm and suddenly too cold and night sweats come and go. Thoughts are racing, replaying the day just gone and worrying about the day ahead. All the while, one knows one really needs some sleep. For many women going through menopause, this is not the occasional bad night. Rather, it is night after night of broken and disrupted sleep. Life is difficult enough as a woman going through menopause without exhaustion making it worse. There are physical symptoms, emotional strain and an impact on work and family life. Sleep is not a luxury; it is an absolute essential.

I am a firm believer that anything which can safely and effectively support women through menopause should be as accessible as possible. As we know, Ireland has made huge progress in this space. The introduction of free HRT has been transformative for many women and shows what can be achieved when we take women's health really seriously. We can do more.

One simple and practical step is to allow low-dose melatonin to be made available over the counter in pharmacies. Melatonin is widely used to support sleep and in many countries it is also available without prescription at low doses, including France, Germany, Italy, Spain, the Netherlands, Poland, the United States and Canada. In Ireland, however, it remains prescription-only.

It is also a great help to neurodivergent children who have difficulty sleeping or need to be made calm before bedtime. It is no longer available on the medical card. The reality is that many women are already accessing melatonin, just not through our system. They are buying it abroad or asking friends or family to bring it back in their luggage. That tells the real story. It tells us that there is a demand and women and parents are actively seeking solutions to this problem. It raises the question as to why we are not facilitating safe and regulated access to melatonin here at home.

This is not about replacing medical care. Rather, it is about recognising that, at low doses, melatonin is considered safe in many jurisdictions and can provide real relief for those struggling with sleep disruption or deprivation. Pharmacists are highly trained professionals and are well placed to advise on appropriate use. Allowing over-the-counter access would ensure women and some children receive proper guidance, rather than relying on informal routes. This is just another small change that could have a really meaningful impact on quality of life. Better sleep supports better physical health, mental well-being and day-to-day functioning. It would also bring Ireland into line with many of our European neighbours who already recognise the huge benefits of making low-dose melatonin more accessible. I am hoping that the Minister of State will examine this issue closely, to engage with the Health Products Regulatory Authority, HPRA, to consider a pathway to allow low-dose melatonin to be made available over the counter in Irish pharmacies. As I have said before, if there is a safe, evidence-based way to help women - and, as I mentioned, neurodivergent children and young people - to sleep better during one of the most challenging phases of their lives then we should be doing everything we can to make that support available.

Jennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail)
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I am taking this on behalf of the Minister, Deputy Carroll MacNeill, who cannot be here today. I thank the Senator for highlighting a really important issue. It is good that we are talking about this and it very important that we look at the changes that can be made.

I will briefly outline some of the details on melatonin. This is most often used to treat insomnia, which is characterised by poor quality of sleep. Melatonin is currently listed in what is called column A of the First Schedule of the prescription and control of supply regulations, SI 540 of 2003. This means that it is a prescription-only medicine that cannot be renewed. In Ireland, all currently authorised melatonin-containing medical products are subject to prescription control. The Health Products Regulatory Authority is the agency in Ireland with responsibility for the regulation of medicines for the benefit of patients. The Department of Health engages closely with the HPRA on its remit. It should be noted that the HPRA is open to review any application from a marketing authorisation holder, MAH, to change the prescription status of melatonin to non-prescription status. This is in line with the HPRA policy to make medicines and health products available at the most convenient point of access for people, where it is safe and appropriate to do so, following the evaluation of all relevant data.

The Department of Health and the HPRA are not aware of any specific MAH applications that are currently under review. Once a marketing authorisation has been issued, it is a matter for the marketing authorisation holder to decide whether to make the medicine available in Ireland. It is important to note that other policy measures have been introduced by the Department in recent years to support women through their menopause journey. I know the Senator spoke about them. It is a priority for us in government.

The Department of Health will keep the matter under review and will be happy to provide the Senator with a further update, should additional relevant information become available. I will go back to the Minister because we need to get more clarification on this. I thank the Senator again for highlighting this really important issue.

Alison Comyn (Fianna Fail)
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I thank the Minster of State for taking it so seriously. I note from the Minister of State's response that the issue has not really moved forward since it was raised in the Dáil last year. I must note that our President, Catherine Connolly, raised this issue. We need to see why it has not been approached by any of the marketing authorities. If there is such a demand for it then clearly it is falling between two stools here. We need to make sure we are bridging that gap to make it available. As I mentioned before, it is a huge bonus to not only menopausal women but also neurodivergent children and people with ADHD. It is not available on the medical card any more. It used to be a great boost to families and now it is costing money. This would really take the burden away. We are not suggesting that it is going to be free but at the same time, making it more freely available would certainly help. I thank the Minister of State for taking this very seriously and I look forward to our next step on it. I will not be letting it go.

Jennifer Murnane O'Connor (Carlow-Kilkenny, Fianna Fail)
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As the Senator noted earlier, the HPRA is open to review any applications from a marketing authorisation holder to change the prescription status of melatonin to non-prescription status. That is the first point of call that we need to look. Additionally, the Government recognises that menopause is a key health issue for women in Ireland today. The Senator also referred to neurodivergent children and people with ADHD, which is important to highlight. Much work has been done to drive progress in this area by the women's health task force and the women's health action plans that we are working on. To support women through their menopause journey we have significantly enhanced the supports available to them. As the Senator said, six specialist menopause clinics have been invested in since 2025. These have had their opening hours extended.

Since 1 June 2025, free HRT has been provided to women experiencing menopause. This is available where it has been prescribed to a woman by a healthcare provider for the purpose of alleviating the symptoms associated with all stages of menopause. We definitely need to go back to the Department and follow this up. As the Senator said, this was brought up last year in the Dáil. The Senator is right that we need to work on this to see how we can bring it further. I thank her again for highlighting this really important issue.

Malcolm Noonan (Green Party)
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I thank all the relevant line Ministers who are with us today. It is appreciated. We do not always get the relevant Minister to the subject matter. I think this is appreciated by the Senators so we hope that continues.