Zaleplon

Sonata's EU marketing authorisation is withdrawn, and the FAMHP medicinal-products database lists no current Belgian zaleplon product. Belgian medicines law nevertheless permits a foreign-authorised medicine to be imported by a pharmacist for a named patient when the prescriber declares that treatment with medicines on the Belgian market is inadequate; Article 105 requires the prescription and written physician declaration. Zaleplon capsules currently have FDA approval as prescription products, so Belgian access falls under this exceptional pharmacist-mediated import route rather than ordinary domestic marketing.

Fimea Decision 230/2025 has been in force since 19 May 2025 and expressly lists zaleplon in Annex 1. Section 2 provides that the Annex 1 substance, including its salts and esters, is supervised as a medicine under section 3(1) or 3(2) of the Medicines Act. The decision also expressly limits that rule at product level: not every product containing a listed substance necessarily meets the definition of a medicine, and Fimea assesses individual products case by case under section 6 of the Medicines Act. Annex 1 listing does not itself establish prescription-only status.

Zaleplon is expressly included under tariff heading 2933.59.99 in Annex I(c) and I(j) of Mexico's health-sector import and export control agreement. Those sections require prior COFEPRIS health authorization for imports and exports of the listed medicines, pharmochemicals, and raw materials. A March 2024 amendment changes only Annex I(f), leaving the zaleplon provisions intact; these cross-border controls do not by themselves establish a domestic prescription schedule.

Norway's medicines regulator states that no medicine containing zaleplon has a Norwegian marketing authorisation. Under § 2-5 of the Human Medicines Regulations, a physician or dentist may requisition a medicine without Norwegian marketing authorisation only on personal responsibility and through a medically justified application; products outside the notification route require an exemption decision by the Directorate for Medical Products. Zaleplon medicinal products are therefore restricted to the approval-exemption route rather than ordinary Norwegian marketing.

Portuguese law permits medicinal products to be marketed only with authorization from INFARMED. The current INFOMED database lists the zaleplom products Sonata and Zerene, in 5 mg and 10 mg capsules, as revoked and without commercial presentations, consistent with the European Commission's withdrawal of their EU authorizations in 2015 and 2012. Zaleplon is therefore not currently authorized for ordinary medicinal sale in Portugal; this restriction concerns marketing status, not a separate criminal prohibition on possession.

Läkemedelsverket's current records identify four Swedish medicines containing zaleplon, and all four are deregistered: Zerene 5 mg and 10 mg since 23 August 2012, and Sonata 5 mg and 10 mg since 3 July 2015. The agency states that medicine packages remaining in stock cannot be sold in Sweden after the deregistration date. The deregistration is a product-market restriction, not a general prohibition on zaleplon. The separate current substance record classifies zaleplon as 'Not narcotic'; the historical 'Prescription only' fields on the deregistered products do not establish current prescription access or controlled-drug status.

Swissmedic's official journal records the revocation of marketing authorization no. 54835 for Sonata 5 mg and 10 mg capsules as of 6 December 2013, and Swissmedic's current authorized-medicines register contains no zaleplon product. Articles 48–49 AMBV permit an unapproved ready-to-use medicine to enter Switzerland only in a small amount for personal use or, under specified conditions, through a licensed medical professional for a named patient or an emergency. Zaleplon medicinal products therefore fall under the limited-import regime rather than ordinary domestic marketing.

Zaleplon is classified as a Schedule IV controlled substance under U.S. federal regulation.¹

The Poisons Standard—June 2026 lists zaleplon in Schedule 4. Schedule 4 substances are prescription-only medicines whose use or supply is by an authorized prescriber’s order and which are available from a pharmacist on prescription.

Austria's Rezeptpflichtverordnung lists ZALEPLON in the human-medicines Part 2 of Annex 1 with the code NR. The annex defines NR as prescription-only with repeat dispensing prohibited, while § 1 subjects the listed medicines and their preparations to the dispensing restriction. Unless expressly stated otherwise, the annex also applies prescription status to salts, esters, and salts of esters.

Zaleplona is listed in Anvisa's List B1 of psychotropic substances under Portaria SVS/MS nº 344/1998 and is subject to the blue Notificação de Receita B. RDC Anvisa nº 871/2024 expressly requires prescriptions and dispensing of zaleplona medicines to use that notification from 1 August 2024, removing the former List B1 addendum exception. The List B1 addendum also places possible salts, ethers, esters, isomers, and their salts under control.

Health Canada added zaleplon to the Prescription Drug List for human and veterinary use effective 1 November 2018 after determining that it requires prescription status. Zaleplon medicines are therefore supplied under Canada’s prescription-drug regime.

A July 2026 Shenzhen Public Security publication reproduces the 2025 national medicinal psychotropic list and places zaleplon in Category II. The list states that the asterisk marks substances produced and used in China and that listed substances include their possible salts and single-ingredient preparations.

The Danish Medicines Agency's current workbook of all authorised medicines, headed as last updated 24 August 2026, contains no row for zaleplon, Sonata, or Zerene; the EMA also records that Sonata's EU marketing authorisation is no longer valid. Under the current prescription order, a medicine without marketing authorisation is always prescription-only and, unless an exception applies, is dispensed under group A rules. The current 2026 euphoriant-substances order does not name zaleplon, while Annex 3 to the prescription order exhaustively names only flunitrazepam, modafinil, and codeine, so the group A § 4 exception is not triggered for zaleplon. The Medicines Act and the Agency's current guidance additionally require a section 29 dispensing permit and a prescription before an unmarketed zaleplon medicine may be supplied by a pharmacy. This classification concerns zaleplon when supplied as a medicine; the cited instruments do not establish a blanket possession ban for non-medicinal material.

The consolidated psychotropics order lists zaleplon in the third part of the French psychotropic-substances schedule. That part covers the named substances, their salts, and preparations containing them, placing zaleplon within the prescription psychotropic-control regime.

Annex 1 of the German Prescription Medicines Ordinance lists zaleplon among prescription-only substances. Medicines containing it, including relevant salts or hydrates, require a prescription unless an express exception applies.

CDSCO identifies zaleplon as a sedative-hypnotic. Under rule 96(1)(xi) of the Drugs Rules, labels for hypnotics and sedatives must carry the applicable scheduled-drug caution; if the drug is not covered by Schedule G, H, H1, or X, the rule applies the Schedule H caution. Rule 97(1)(b) states that this caution prohibits retail sale without a Registered Medical Practitioner's prescription.

The Misuse of Drugs Regulations 2017 list zaleplon in Part 1 of Schedule 4. Possession for medical administration is authorized in accordance with practitioner directions, and supply is subject to controlled-drug prescription requirements.

Zaleplon is listed among controlled psychotropic active substances in Tabella medicinali, Sezione B, of Italy's D.P.R. 309/1990; Article 14 extends the schedules to applicable isomers, esters, ethers, salts, and stereoisomers unless expressly excepted. Non-parenteral medicinal compositions containing zaleplon are listed in Sezione E, whose supply classification is a repeatable medical prescription. The D.M. 8 February 2001 establishes the original national scheduling by adding zaleplon to the former Table IV and Sonata and Zaleplon-Wyeth Medica Ireland capsules to the former medicinal Table V.

Zaleplon is classified as a prescription medicine under New Zealand's medicines framework. The classification notice places zaleplon in Schedule 1 and declares the medicines in that schedule to be prescription medicines; a November 2025 Gazette notice again includes zaleplon among specified prescription medicines for designated pharmacist prescribers. Unless specifically excluded, the classification also covers preparations and admixtures containing the listed substance and its salts and esters.

As of 23 August 2026, the current official ELI history identifies exactly two amendments after the 2024 consolidated text: Dz.U. 2025 poz. 598, effective 22 May 2025, and Dz.U. 2026 poz. 934, effective 28 July 2026. The consolidated text expressly lists ZALEPLON, with its matching chemical identity, as item 70 in psychotropic group IV-P. The 2025 and 2026 amendments modify the IV-P table only by adding items 80 (bromazolam) and 81 (carisoprodol), respectively, and do not alter item 70. Article 41(2) of the Act on Counteracting Drug Addiction makes pharmacy dispensing of preparations containing narcotic drugs or psychotropic substances prescription-based, subject to paragraph 4; paragraph 4 permits group IV-P preparations to be dispensed on prescriptions other than the specially marked prescription described in paragraph 2. Zaleplon preparations are therefore prescription-only, with an ordinary rather than specially marked prescription permitted.

SAHPRA's current Consolidated Schedules page identifies the latest version as updated on 6 July 2026 and marks the 1 August 2025 PDF as an archived version that must not be used. The linked 6 July 2026 consolidation expressly lists Zaleplon in Schedule 5 without an exception or the double-asterisk marker used for specified Schedule 5 substances. SAHPRA's current scheduling guideline states that medicines containing Schedule 3 through Schedule 6 substances can only be obtained on the prescription of an authorised prescriber. Government Notice R.7446 in Gazette 54627, effective 8 May 2026, amended Schedule 4 only and is reflected in the later July consolidation.

The current Enforcement Decree, effective 1 February 2026, assigns the psychotropic drugs in Article 2(3)(a) through (e) of the Act to Schedules 3 through 7. The current Schedule 6 expressly lists 잘레플론 (Zaleplon), with its chemical identity, as item 74 in the Article 2(3)(d) category. The schedule is marked amended 12 August 2025; its deferred 13 February 2026 commencement notation applies to the amendment of item 83, not to zaleplon. Under the current Act, non-handlers generally may not possess, use, sell, administer, or otherwise handle psychotropic drugs, subject to exceptions including receipt from an authorized medical practitioner or purchase from a licensed narcotics retailer. Retail sale is tied to a prescription issued by an authorized medical practitioner, and only an authorized narcotics-handling medical practitioner may administer a psychotropic drug for medical care or issue a prescription for one. Zaleplon therefore has legal medical use within the prescription and licensing regime.

The Thai FDA controlled-psychotropic table lists zaleplon in Category II under the Narcotics Code B.E. 2564 (2021). Medical possession and import are subject to Thailand’s controlled psychotropic regime and its prescription or authorization requirements.

Ukraine classifies zaleplon as a prescription medicine through the current State Register record for Selofen. The record identifies the INN as Zaleplon, lists registration UA/5258/01/01 as unlimited from 6 August 2021, and states that dispensing is by prescription. It records the current registration under Ministry of Health Order No. 386 of 23 March 2026.

The Emirates Drug Establishment lists zaleplon as a controlled drug (CD). Travelers may carry only the quantity needed for their stay, capped at three months, and must hold a medical prescription or attested medical report from a health provider. The establishment's personal-import service treats narcotic and psychotropic medicines as controlled medications and requires the medicine name and treatment details in the supporting prescription or medical report.