BSPSS Position on the Proposed Reclassification of Sleep Aids

The British Society of Pharmacy Sleep Services (BSPSS) is deeply concerned by the Department of Health and Social Care’s (DHSC) reported intention to reclassify certain ‘short-term’ sleep aids – potentially including melatonin, sedating antihistamines, and prescription-only hypnotics – to less restrictive categories such as Pharmacy (P) or General Sales List (GSL).

Without transparency about the scope of these proposals, and in the absence of accompanying safeguards, we believe such a move could undermine evidence-based care, trivialise sleep health, and increase the risk of inappropriate use, dependency, and harm.

1. A Step Backwards for Evidence-Based Practice

National and international guidelines – including those from NICE, the American Academy of Sleep Medicine (AASM), and the European Sleep Research Society (ESRS) – explicitly advise against routine use of pharmacological interventions for insomnia, particularly sedating antihistamines and other OTC sleep aids.

These recommendations are grounded in robust evidence showing limited efficacy, next-day sedation, and risk of dependence.

Expanding public access to sleep aids that are not recommended in clinical guidance, directly contradicts the direction of safe, person-centred care.

2. Reclassification Risks Masking Serious Sleep Disorders

Sleep difficulties are often symptoms of underlying clinical conditions – including insomnia disorder, generalised anxiety, sleep apnoea, and circadian rhythm disorders.

Increasing public access to symptomatic treatments without adequate clinical assessment risks normalising poor sleep, thus delaying the identification and management of underlying health issues.
Pharmacists are ideally placed to assess sleep concerns and signpost to appropriate care.

Removing professional oversight would be a missed opportunity to intervene early and safely.

3. Incompatible with Deprescribing and Public Health Policy

NHS England’s polypharmacy and deprescribing programmes aim to reduce unnecessary use of medicines with limited long-term benefit – particularly hypnotics and sedating agents.

Making such products more accessible through down-scheduling runs counter to these ambitions and risks reinforcing a medication-first mindset at odds with the wider public health agenda.

4. Rising Patterns of Misuse and Dependency

Sedating antihistamines such as diphenhydramine and promethazine, though widely available, are associated with rising patterns of inappropriate use, especially among younger adults and older people.

Off-label use, dose escalation, and chronic reliance are well-documented and poorly addressed in current community practice. Further deregulation may exacerbate these trends.

Prescription hypnotics – including the so-called ‘Z-drugs’ (zopiclone, zolpidem, zaleplon) – are subject to strict prescribing criteria and Schedule 4 controls due to their potential for dependency and misuse.

Any move to reduce restrictions on these agents would currently be of serious concern and entirely unjustifiable on clinical or safety grounds.

5. Driving-Safety Alert (next-day sedation)

Sedating antihistamines and hypnotics can leave psychomotor impairment the morning after comparable to (or worse than) driving above 0.05 % BAC – raising crash risk by 40-100 % in the first 24 h post-dose. Regulators insist on at least 8–9 h between dosing and driving, yet residual drowsiness may still occur; widening access without pharmacist counselling therefore risks avoidable, fatigue-related collisions.

6. Caution Around Melatonin is Still Warranted

Although melatonin is better aligned with circadian-based sleep disorders and has a more favourable safety profile, its reclassification should not be seen as a panacea.

Without structured guidance and pharmacist training, inappropriate long-term use, off-label prescribing, and misplaced expectations remain significant risks – especially in vulnerable groups.

BSPSS Recommendations

To ensure patient safety and uphold standards in sleep health, we urge the DHSC to:

1. Clarify the scope of proposed reclassifications, including which substances are under consideration.
2. Maintain current restrictions on sedating antihistamines, Z-drugs, and other products not supported by NICE or international guidelines.
3. Ensure any reclassification of melatonin is accompanied by mandatory pharmacist education, guidance on appropriate use, and structured pathways for deprescribing.
4. Embed sleep health education into pharmacy practice, empowering pharmacists to lead non-pharmacological, guideline-aligned interventions for sleep concerns.

BSPSS Final Position

At this juncture, The British Society of Pharmacy Sleep Services (BSPSS) strongly opposes the reclassification of sleep aids to Pharmacy or General Sales List categories, due to risks of harm, guideline contradiction, and undermining of deprescribing efforts.

We cautiously support the potential reclassification where clinically appropriate, provided it is accompanied by robust, independent and non-product led pharmacist training and safeguards to prevent misuse.

The BSPSS remains committed to promoting safe, evidence-based sleep care in community pharmacy and ensuring pharmacists are empowered to deliver interventions that improve lives.

Contact

For further information, please contact:
• Gareth Evans, President – g.evans11@nhs.net
• Adrian Zacher, CEO – hello@bspss.org