Overview
Zaleplon is a non-benzodiazepine hypnotic belonging to the “Z-drug” class, historically used for short-term management of insomnia, primarily for difficulties with sleep onset. Although widely prescribed in the early 2000s, Zaleplon’s regulatory status has shifted over time due to safety assessments and changes in the UK medicines licensing framework.
Under UK medicines law, hypnotics are highly regulated. As with other sedative medications such as Zolpidem and Trazodone, the legal classification of Zaleplon directly determines its availability, prescribing rules, and importation restrictions.
Is Zaleplon Legal in the UK?
Prescription-Only Medicine (POM)
Under the Human Medicines Regulations 2012, Zaleplon is legally classified as a Prescription-Only Medicine (POM). This means it can only be supplied with a valid prescription issued by a UK-registered healthcare professional.
The Medicines and Healthcare products Regulatory Agency (MHRA) maintains the authoritative classification system for all UK medicines.
Controlled Drug Classification (Class C)
Zaleplon is also governed by the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001, which categorize controlled substances according to misuse potential. Following the Advisory Council on the Misuse of Drugs (ACMD) recommendation in 2013, all Z-drugs — Zaleplon, Zolpidem, and Zopiclone — were placed under:
- Class C (Misuse of Drugs Act 1971)
- Schedule 4, Part I (Misuse of Drugs Regulations 2001)
This classification imposes additional dispensing, record-keeping, and storage requirements for pharmacists and prescribers.
Marketing Authorisation Status
A key regulatory factor is that Zaleplon no longer holds an active marketing authorisation in the UK. This is confirmed by the National Institute for Health and Care Excellence (NICE):
As a result, Zaleplon is legal, but no longer commercially marketed, limiting its availability in UK pharmacies.
Clinically, prescribers typically default to currently authorised alternatives such as Zolpidem or Zopiclone.
Practical Implications for Patients
- A prescription is required for any legal possession or dispensing.
- Since no licensed UK products are marketed, obtaining Zaleplon within the UK may be impossible through normal pharmacy channels.
- Pharmacists must comply with controlled-drug protocols under the Misuse of Drugs Regulations.
- Prescribing is limited due to the absence of active marketing authorisation.
- Importing Zaleplon for personal use can trigger customs scrutiny.
Importation & Travel Rules
The UK applies strict controls on importing prescription medicines. Under HMRC and UK Border Force policy:
- Individuals may bring personal medication into the UK for personal use only, and
- Controlled drugs (including Z-drugs) typically require supporting documentation.
Travellers carrying Zaleplon into the UK must have:
- A valid prescription
- Original packaging
- A personal-use quantity
- A doctor’s letter if carrying Schedule 4 substances
Because Zaleplon lacks a current UK marketing authorisation, travellers may face questions at customs, even with documentation.
Legal Risks of Unauthorised Supply
Under the Misuse of Drugs Act 1971, unlawful possession or supply of Class C controlled substances may result in:
- Fines
- Seizure of medication
- Criminal prosecution for unlawful supply or import
Cases involving other hypnotics such as Zolpidem (UK) demonstrate that improper distribution can result in removal from the GPhC register and criminal consequences.
Alternatives to Zaleplon in the UK
Because Zaleplon is no longer marketed, clinicians rely on alternative hypnotics with full authorisation. The most commonly prescribed substitutes include:
A short-acting Z-drug licensed for short-term treatment of insomnia. See:
Zopiclone
A widely used Z-drug with predictable onset and established clinical utility. See:
Zopiclone
Melatonin (prolonged-release)
Authorised for patients aged 55+, often used before sedative-hypnotics.
Temazepam (benzodiazepine)
Schedule 3 controlled hypnotic, used when Z-drugs are inappropriate.
An antidepressant with sedative properties sometimes prescribed for insomnia related to mood disorders.
NICE guidelines emphasise that all hypnotics should be used short-term only, supported by behavioural sleep interventions.
Summary Table
| Legal Factor | Status in the UK |
|---|---|
| Prescription-only | ✔ Yes (POM) |
| Controlled drug | ✔ Class C, Schedule 4 Part I |
| Marketing authorisation | ❌ No active UK authorisation |
| Legal to possess with prescription | ✔ Yes |
| Legal to import | ✔ With documentation; scrutiny likely |
| OTC availability | ❌ Not permitted |
Summary
Zaleplon remains legal in the UK, but its marketing authorisation has lapsed, and it is regulated as a Class C controlled, prescription-only medicine. This means patients will find it difficult to obtain within the UK, and doctors typically prescribe licensed alternatives such as Zolpidem, Zopiclone, or Trazodone.
Anyone travelling with or using hypnotics must follow the UK’s strict regulations under the Human Medicines Regulations 2012 and the Misuse of Drugs legislation.