Loprazolam is a UK prescription medicine for short-term severe insomnia. UK label.
- Confirm the exact dispensed product, reason for treatment, review contact and stopping plan.
- Suspected benzodiazepine overdose needs immediate emergency help. MHRA.
- Do not increase intake or abruptly stop an established prescription; arrange an individual review.
- Pregnancy needs assessment; breastfeeding use is prohibited. Leaflet.
- This review does not establish independently cleared long-term superiority over another hypnotic.
Table of contents
- Evidence summary
- Loprazolam, Dormonoct and Havlane
- How loprazolam works
- Insomnia care
- Supplement and lifestyle evidence
- What the studies establish and what remains unresolved
- Overdose, allergy and behaviour
- Medicine interactions
- Contraindications and reproduction
- Use and withdrawal
- Human-study limits
- Funding and source roles
- Frequently asked questions
- Sources and funding notes
Evidence summary
Clinical descriptions, care guidance and independently established treatment outcomes have different evidentiary roles. The table identifies what the reviewed sources can support and which financial or clinical questions remain unresolved.
| Question / approach | Evidence reviewed | Funding / conflicts | Interpretation / limits |
|---|---|---|---|
| Severe insomnia | UK label | Maker-produced | Short-course context. |
| Historical trial | Seven-night hospital study | Roussel medical-department coauthor | Commercially produced outcomes excluded. |
| Dependence/withdrawal | January 2026 MHRA/NICE guidance | Agency fees and committee gaps | Individual stopping care; no self-taper. |
| Breastfeeding | UK leaflet; broader SPS assessment | Maker instruction; underlying evidence gaps | No loprazolam-specific safety clearance. |
| Complementary products | NCCIH uncertainty and safety | Dated public routes; reviewer/trial gaps | No independent substitute or safe stack established. |
| Use frequency | 9,349 English community items | NHSBSA funding route | Not people, global rank or effectiveness. |
Loprazolam, Dormonoct and Havlane
UK 1 mg tablets contain loprazolam mesylate. UK pack.
France’s March 2026 Havlane record names loprazolam and holder Teofarma. Country-specific records do not establish stock. French product record.
Dormonoct 2 mg is a loprazolam brand in a South African professional document revised 10 July 2023. That dated document does not prove its current holder or availability. Dated South African document.
England’s 2025/26 chemical-substance table records 9,349 loprazolam mesilate prescription items. Original public table.
An item count reflects community prescribing/dispensing records, not individual patients, hospital supply, insomnia-only use, search interest or treatment success. It is a bounded coverage-priority measure. Methods.
How loprazolam works
The French professional label describes action at the benzodiazepine/GABA receptor complex and effects including sedation, muscle relaxation and amnesia. Pharmacology does not establish long-term comparative benefit or safe driving. Professional pharmacology.
The useful clinical question is the agreed treatment goal and unwanted effects together. A discussion of falling asleep should also include functioning while awake. At review, distinguish what you hoped would improve from what actually changed; a medicine’s mechanism is not a substitute for that account.
Our financial screen evaluates who produced or paid for outcome evidence separately from the medicine’s recognized prescribing role. It does not turn a source’s commercial connection into proof that every observation is wrong. It limits which observations can support an independent verdict.
Insomnia care
Courses: days–two weeks; four-week maximum includes tapering; established withdrawal may take longer. UK prescribing scope.
NHS assessment considers pain, anxiety, medicines, shift work and other sleep disorders. Care may include CBT in person or online, and sleep-clinic referral for another suspected disorder. A hypnotic does not replace assessment of the cause. Insomnia care.
Ask which team coordinates prescriptions and reviews when care transfers.
The January 2026 MHRA warning stresses that dependence, tolerance and withdrawal can occur during short prescribed use. Agree how treatment will end before starting, and contact the prescriber if its effect changes. Do not increase it or add another sedative yourself. Current warning.
Supplement and lifestyle evidence
NCCIH describes inconsistent valerian evidence and potentially serious kava-related liver injury. The reviewed material does not establish an independent supplement replacement for loprazolam or a combination that improves its safety. Uncertainty and hazards.
Show the pharmacist actual ingredient lists, including non-prescription and online sleep products. Supplements can interact with medicines and their contents or claims may not match expectations; advertising cannot establish compatibility. Supplement safety.
A regular sleep routine and addressing habits that disrupt sleep can support care. Persistent impairment still needs assessment; do not drive when sleepy. Sleep habits.
Bring an account of what you have already tried. Ask which parts of the existing care plan remain appropriate and which changes the team wants documented before review. Do not interpret this article’s uncertainty verdict as a recommendation to experiment with combinations or to abandon a prescribed plan.
What the studies establish and what remains unresolved
The 1984 publisher abstract describes a seven-night hospital comparison using subjective sleep ratings. A coauthor worked in Roussel’s medical department. Its positive outcomes are excluded from this guide’s independent efficacy verdict; short observation cannot establish years-long safety. The full funding/supply declarations were not obtained. Historical original record.
A 2023 review’s available reference list includes that trial. The review declares no specific grant and no competing interests, but this does not remove commercial provenance from the underlying evidence. The full analysis was not accessed; no pooled loprazolam ranking is adopted here. Review source-chain limits.
MHRA’s 2026 assessment considered licence-holder data, spontaneous reports, prescribing records and stakeholder input. It reviewed risk communication, not each drug’s efficacy, dose or indication; specialist epilepsy and procedural uses were excluded. Actual review scope.
No financially cleared long-term superiority estimate is established by these reviewed sources. This is an evidence limit, rather than a prediction that nobody benefits. Prescribing context, safety communication and independently funded comparative results answer different questions.
Overdose, allergy and behaviour
Suspected benzodiazepine overdose: call 999 immediately in the UK, local emergency services elsewhere. Do not wait for symptoms or use home antidotes. Immediate overdose action.
Extra intake: doctor/casualty immediately; bring pack. Serious allergic swelling: stop, seek doctor/hospital immediately. Leaflet.
Swelling of the mouth, lips, throat or tongue, trouble swallowing/breathing or collapse can signal anaphylaxis: get emergency help immediately. Serious allergy action.
The dated Dormonoct document lists sedation, confusion, impaired coordination, memory loss and paradoxical excitement or aggression. These reports are safety context, not a frequency estimate for your UK product. Reported effects.
Havlane’s notice also describes unusual or automatic behaviour with memory disturbance and urges prompt prescriber contact. Behaviour warning.
Falls require injury assessment and medicine/home-hazard review. Inability to get up or suspected head, back, neck or hip injury needs immediate emergency help: call 999 in the UK, local emergency services elsewhere. Falls care.
Reported suicide associations do not establish causation. Leaflet.
Tell a professional about suicidal thoughts promptly. NHS advice directs immediate emergency help after serious self-harm or when you may be about to harm yourself. Crisis assessment.
Urgent warnings override continuity advice; bringing the pack must not delay care.
Medicine interactions
Benzodiazepines with opioids can cause additive sedation, respiratory depression, coma and death. MHRA restricts co-prescribing to situations without an alternative and requires close monitoring. Breathing difficulty or severe sedation needs immediate medical attention. Opioid warning.
Avoid alcohol. Review sedating medicines, anaesthetics, cisapride and muscle relaxants with a pharmacist; an unlisted combination is not cleared. Product interactions.
Keep questions about the review contact and conflicting instructions with your appointment notes.
Contraindications and reproduction
Contraindications include benzodiazepine allergy, acute pulmonary insufficiency and severe respiratory insufficiency, myasthenia, sleep apnoea and phobic/obsessional states; also sole therapy for depression/associated anxiety or chronic psychosis. Organ disease/frailty need assessment. Professional precautions.
Do not give loprazolam to children. Leaflet.
Clarify the leaflet’s heart/psychiatric restrictions. Pregnancy use is discouraged; breastfeeding use prohibited. Late pregnancy can affect neonatal breathing/feeding and withdrawal. Patient restrictions.
SPS covers healthy full-term infants with poor/limited evidence; loprazolam is not listed. Seek individual assessment, especially for a premature/unwell infant. No bedsharing after sedatives. Specialist scope.
Use and withdrawal
Forgotten bedtime tablets: not later in the day; never double. Missed-dose instruction.
Do not drive until effects are known; never drive/use machinery while impaired. Driving precaution.
NICE recommends agreed review and adaptable gradual withdrawal. Assess symptoms for withdrawal, recurrent or new illness; abrupt stopping requires exceptional medical justification. Withdrawal care.
Withdrawal can include seizures and loss of the sense of reality. A medical emergency requires immediate emergency help. Established withdrawal may take weeks or months; physical dependence does not necessarily mean addiction. Patient withdrawal resource.
Contact the prescriber about supply disruption.
For the review, describe actual use and changes in symptoms honestly. Bring the pack, prescription and medicine list, and ask which unanswered concerns need follow-up. These are consultation prompts, not a self-screening process that makes continued use safe.
Human-study limits
This guide adopts no animal or test-tube outcome as proof of human insomnia benefit, safe pregnancy, breastfeeding safety or a personal dose. A pharmacological explanation and a short clinical observation cannot settle all of those outcomes. No animal-to-human dose conversion is offered.
Pharmacokinetics: six healthy young men; preclinical text adds nothing relevant. Study-population limit.
The evidence screen also does not treat a missing result in a product document as proof that no such research exists. It records what the originals actually inspected can support, which financial chains remain open, and which outcomes this article cannot independently establish.
Funding and source roles
Research funding at a glance
40 disclosure entries. The counts below summarize independence tiers explicitly assigned in this article. They count disclosures, not studies, funding amounts or evidence quality.
Consult this article’s source and funding notes for named funders, countries, relationships and exceptions where available. Institutional backing, researcher interests and trial sponsorship are separate questions. Public funding alone does not establish independence; commercial ties alone do not prove a claim false. This overview is not a new financial audit.
The source-specific map separates documented institutional funding from disease-page payments and trial sponsorship. Unknown allocations remain unknown. A public agency, charity or academic address does not by itself establish independent treatment efficacy.
| Source | Funding / backers | Country / jurisdiction | Independence | Credibility / incentives / gaps |
|---|---|---|---|---|
| NHS national website content policy | Dated DHSC website funding; no ads/corporate sponsorship stated. Individual provider finances and current contracts unclosed. | England, United Kingdom; national website jurisdiction | Tier 3 — institutional financial/process self-report | B provisional process self-report. Reviewed 14 October 2022; October 2025 review due has passed. |
| NCCIH FY 2025 congressional justification | NIH/HHS federal budget route; historical request, not current enactment. Gifts/page allocation unclosed. | United States; NCCIH, Bethesda, Maryland | Tier 3 — institutional financial/process self-report | B provisional historical self-report. Page says it no longer reflects current HHS policy; budget-advocacy incentives. |
| NCCIH: sleep and complementary approaches | Dated fiscal route below. Credited NCCIH reviewers’ outside interests and original-study finances unclosed. | United States; Bethesda, Maryland | Tier 2 — public safety/uncertainty context | C provisional. May 2024. Public education; no independent product efficacy adopted. |
| NCCIH: supplement safety | See dated fiscal row; page/expert and original-study finance unclosed. | United States; Bethesda, Maryland | Tier 2 — public safety context; provisional | C provisional. Footer January 2019 despite later references; date limit retained. |
| MHRA 2025/26 audited accounts | Industry statutory/nonstatutory fees, DHSC grants and service/research income; warning/adviser allocation unknown. | London, UK | Tier 3 — institutional financial self-report | B provisional. 15 July 2026; selected audited notes read; backer chain unclosed. |
| eMC: publishing and payment process | Datapharm owns/manages eMC; pharma subscriptions pay for publishing. Companies draft/publish regulator-approved labels; complete ultimate-owner chain unclosed. | UK; Cassini Court, Randalls Way, Leatherhead | Tier 4 — paid maker publishing channel | B provisional process facts; D for independent efficacy. Paid-publication incentives persist after regulatory review. |
| NHSBSA: loprazolam community items | Authority finance below; exact PCA allocation, contributor and capture-chain interests unclosed. | England data; UK authority, Newcastle upon Tyne | Tier 2 — public statistics; provisional | B provisional. June 2026 release; reimbursement records do not measure treatment benefit. |
| NHSBSA: prescribing methodology | Authority finance below; exact PCA allocation, contributor and capture-chain interests unclosed. | England data; UK authority, Newcastle upon Tyne | Tier 3 — institutional method self-report | B provisional. June 2026 release; reimbursement records do not measure treatment benefit. |
| NHSBSA: 2025/26 prescribing publication | Authority finance below; exact PCA allocation, contributor and capture-chain interests unclosed. | England data; UK authority, Newcastle upon Tyne | Tier 2 — public statistics; provisional | B provisional. June 2026 release; reimbursement records do not measure treatment benefit. |
| NHSBSA: 2025/26 audited institutional accounts | DHSC sponsor/appointed board; Parliamentary funding, full-cost contracts and public repayment/student-support routes. PCA allocation, staff/contractor interests unknown. | Newcastle upon Tyne, UK | Tier 3 — institutional financial/identity self-report | B provisional. Report printed 13 July 2026; selected notes read. Service incentives; complete backer chain unclosed. |
| NICE: 2025/26 accounts | DHSC/NHS England support, appraisal/advice fees, research/licences and other income. Exact NG215 allocation unknown. | UK; Manchester/London | Tier 3 — institutional financial self-report | B provisional selected financial facts. Current accounts cannot clear a 2022 committee. |
| NICE NG215: committee membership | NICE-appointed group; Margaret Lally chaired from January 2021, Cathy Stannard topic adviser. Named affiliations do not disclose payments. | UK; guideline committee | Tier 3 — institutional process self-report | B provisional membership facts. Full interests/contracts and original-trial funds remain unclosed. |
| SPS: own commissioning disclosure | NHS England commissioning of provider-trust contracts/subcontracts. Stated contracts end 31 March 2026; subsequent renewal and page allocation unverified. | England, UK; multiprovider network | Tier 3 — institutional funding/process self-report | B provisional dated disclosure. Current October 2026 arrangements and contributors’ interests unknown. |
| NHS: falls and medicine review | Dated national policy below; exact page, contributor and trial finances unclosed. | England, UK; national website | Tier 2 — public clinical context; provisional | C provisional. Reviewed 6 March 2025. Public-service incentives; no cleared drug outcome. |
| Companies House: 2025/26 accounts | Statutory service fees, DBT/Treasury funding and Economic Crime Levy. Host funding is not pharmaceutical company capital. | UK; Cardiff office, UK register | Tier 3 — institutional financial/process self-report | B provisional. Updated 16 July 2026. Selected finance/office passages read; filings remain company-supplied. |
| Loprazolam SmPC | Zentiva; backers below. Receipts unknown. | London, UK | Tier 4 — maker-produced; self-interest | D efficacy. Text 12 January 2026, posted 19 January. Safety context; trial funds unknown. |
| Loprazolam leaflet | Zentiva holder; Opella Poland manufacturer. Backers below. | UK licence; Rzeszów, Poland manufacturer | Tier 4 — maker-produced; self-interest | D efficacy. November 2025 text, posted 14 January 2026. Safety context. |
| MHRA: January 2026 dependence warning | Public/industry-fee route below; warning and adviser allocation unclosed. | UK regulator; London | Tier 3 — industry-fee regulator; safety context | C provisional. 8 January 2026. Safety communication; not an efficacy reassessment. |
| MHRA: benzodiazepine patient resource | Agency finance below; leaflet/adviser allocation unknown. | UK; MHRA London | Tier 3 — industry-fee regulator; safety context | C provisional. Linked 8 January 2026. Class safety advice; epilepsy excluded. |
| MHRA: 2026 assessment report | Licence-holder data plus public/stakeholder evidence; agency route below. Exact adviser interests unclosed. | UK; MHRA London | Tier 3 — industry-fee regulator; safety context | C provisional. January 2026, 42 pages. Communication review; no drug-specific benefit ranking. |
| MHRA: opioid combination warning | Agency financial row; specific conclusion/payments unclosed. | UK; MHRA London | Tier 3 — industry-fee regulator; safety context | C provisional. 18 March 2020. Statutory safety communication, not a comparative study. |
| NHS: insomnia assessment | National policy below; page, reviewer and trial allocation unclosed. | England, UK | Tier 2 — public clinical context; provisional | C provisional. 19 March 2024; due March 2027. Care context, not cleared efficacy. |
| NHS: anaphylaxis | National policy below; specific page/contributor payments unclosed. | England, UK | Tier 2 — public clinical context; provisional | C provisional. 21 June 2023; June 2026 review overdue. Emergency advice. |
| NHS: suicidal thoughts | National policy below; exact contributor allocation unknown. | England, UK | Tier 2 — public clinical context; provisional | C provisional. 26 April 2024; due 2027. Crisis-care context. |
| SPS: benzodiazepines and breastfeeding | Own commissioning row below; page reviewer and original-study finance unclosed. | England, UK; provider network | Tier 2 — public clinical context; provisional | C provisional. 15 February 2024. Poor/limited evidence; healthy full-term infants. Loprazolam not listed. |
| NICE NG215: withdrawal care | Own accounts/membership below; 2022 committee interests and trials unclosed. | England; NICE Manchester/London | Tier 2 — public clinical context; provisional | C provisional. 20 April 2022. Added MHRA link does not redate guideline. |
| McAlpine et al.: 1984 hospital trial | Coauthor S. I. Ankier: Roussel medical department. Exact grants, drug supply and other payments unclosed. | UK; Paisley/Wembley | Tier 4 — maker-affiliated production; self-interest | D efficacy. Publisher-indexed abstract/affiliations read; direct full text 403, mirror timeout. Seven-night subjective study. |
| Pan et al.: 2023 insomnia review | No specific grant and no competing interests self-declared. Correspondents Long Ge/Kehu Yang; institutional, publisher and underlying-trial funds unclosed. | China; Lanzhou/Sichuan; Belgium; Canadian coauthor | Tier 2 — financial chain unresolved; provisional | C provisional. 22 March 2023. Actual abstract/references/declarations; full analysis paywalled. Pooling is not trial clearance. |
| France: Havlane product documents | Teofarma holder, Valle Salimbene Italy. Maker receipts/ultimate owners and host allocation unclosed. | France licence; Italian holder | Tier 4 — maker-produced; self-interest | D efficacy. ANSM update 4 March 2026; internal revision placeholders blank. Public hosting does not clear maker evidence. |
| South Africa: Dormonoct PI | Dated Sanofi-aventis South Africa holder, Midrand. Current holder/transfer, receipts and host funds unclosed. | South African record | Tier 4 — maker-produced; self-interest | D efficacy. Text 10 July 2023; upload July 2024. Dated brand context, not 2026 supply proof. |
| Zentiva UK: legal identity | Company-filed active private medicine wholesaler. Register does not verify supplied filings. | UK; 12 New Fetter Lane, London | Tier 4 — maker-produced; self-interest | D independent claims. Current record; latest accounts December 2025. Product-level receipts unclosed. |
| Zentiva UK: control statement | No active registrable PSC; April 2026 statement. Former Ai Sirona controller ceased 8 April 2026; not ownerless. | UK record; former Luxembourg entity | Tier 4 — maker-produced; self-interest | D independent claims. Filing is not ultimate-owner or lender clearance. |
| Zentiva UK: FY 2025 accounts | Medicine sales, group purchasing/finance and parent debt. Note 24: historical 100% Ai Sirona/Advent; April 2026 GTCR completion. | UK company; Prague group/Luxembourg parent | Tier 4 — maker-produced; self-interest | D independence. Filed 19 June 2026; selected scanned pages read. No loprazolam revenue or personal-payment clearance. |
| Zentiva/GTCR: completed acquisition | GTCR bought Zentiva from Advent 9 April 2026. Named banks are advisers; exact fund investors, lenders and stake unclosed. | Prague, Czech Republic; Chicago, US | Tier 4 — maker-produced; self-interest | D independent claims. Actual completed-deal self-report; growth/exit incentive, not clinical evidence. |
| Zentiva: own company contacts | Commercial group directory; holding-company and factory addresses differ. Product-batch routing unclosed. | Zentiva Group, Prague, Czech Republic | Tier 4 — maker-produced; self-interest | D independent claims. Current contacts self-report; no product quality or factory inference. |
| GTCR: dated capital route | 2024 newsletter describes limited-partner fund capital. Specific Zentiva fund, beneficial investors and receipts unclosed. | US; Chicago investor | Tier 4 — investor-produced; self-interest | D independent claims. Spring 2024, selected p4. Historical investor promotion, not current fund allocation. |
| Opella Poland: own legal notice | Own notice identifies Polish company as Opella-group member. Exact subsidiary shareholding/current manufacturing receipts unclosed. | Warsaw, Poland | Tier 4 — maker-produced; self-interest | D independent claims. Undated own identity notice. Website statement is not an audited capital chain. |
| Opella: 30 April 2025 closing | Company declares CD&R 50.0%, Sanofi 48.2%, Bpifrance 1.8%. Ultimate fund investors and product receipts unclosed. | France-headquartered group | Tier 4 — maker-produced; self-interest | D independent claims. Completed-deal promotion; ownership separation is not unbiased research. |
| Opella: transaction lawyer’s financing disclosure | CD&R’s adviser describes secured notes, term loans, revolver and PIK notes. Lender/noteholder identities and product allocation unclosed. | France transaction; international adviser | Tier 4 — paid-adviser source; self-interest | D independent claims. 30 April 2025. Paid-adviser deal promotion; financial-only context. |
| Sanofi: June 2026 prospectus | Issuer’s commercial-medicine/debt route; p105 retains 48.2% Opal JV interest and Bpifrance~1.8%. Specific factory/product revenue unclosed. | France issuer; multinational interests | Tier 4 — maker-produced; self-interest | D independent claims. 4 June 2026; selected p102/105 read, not complete beneficial-owner audit. |
Frequently asked questions
Can I substitute a foreign brand? Do not substitute or convert yourself. Confirm the exact product and jurisdictional instructions with the pharmacist. Source.
Can dependence happen at a prescribed dose? Yes. Short prescribed use can cause dependence or withdrawal; discuss changes with the prescriber. Source.
What should I do after suspected overdose? Get emergency help immediately, before symptoms. MHRA says 999 in the UK; use the local emergency service elsewhere. Source.
What if withdrawal lasts longer than the planned course? Discuss an adaptable individual plan; do not abruptly stop to meet a deadline. Source.
Does general benzodiazepine breastfeeding advice clear loprazolam? No. Loprazolam is not individually assessed there; maternal/infant circumstances need specialist review. Source.
Does this guide provide a dose or taper? No. Ask the clinician and dispensing pharmacist to confirm your exact product and individual written plan. This guide explains evidence and safety boundaries.
Sources and funding notes
Reviewed 5 October 2026. Access and financial gaps are recorded per source; no personal regimen is provided.
- NHS national website content policy — National website policy, not provider or trial finance.
- NCCIH FY 2025 congressional justification — Institutional route only; no present appropriation or product efficacy.
- NCCIH: sleep and complementary approaches — Valerian uncertainty, kava hazard and no substitute claim.
- NCCIH: supplement safety — Full ingredient disclosure and interaction uncertainty.
- MHRA 2025/26 audited accounts — Agency finance; not warning-specific allocation.
- eMC: publishing and payment process — Label provenance only, not neutral trial evidence.
- NHSBSA: loprazolam community items — England community items; not patients, global popularity or benefit.
- NHSBSA: prescribing methodology — Community versus hospital scope and item definition.
- NHSBSA: 2025/26 prescribing publication — Date and scope, not worldwide popularity.
- NHSBSA: 2025/26 audited institutional accounts — Institutional finance; no item-accuracy or efficacy clearance.
- NICE: 2025/26 accounts — Institutional income only; guideline/trial interests separate.
- NICE NG215: committee membership — Identities only, not financial independence clearance.
- SPS: own commissioning disclosure — SPS-specific route; national NHS website policy not substituted.
- NHS: falls and medicine review — Falls assessment, home hazards and urgent injury care.
- Companies House: 2025/26 accounts — Register institutional route, not filing verification.
- Loprazolam SmPC — Prescribing limits.
- Loprazolam leaflet — Pack safety instructions.
- MHRA: January 2026 dependence warning — Dependence during prescribed use and stopping discussions.
- MHRA: benzodiazepine patient resource — Immediate suspected-overdose action; no home taper.
- MHRA: 2026 assessment report — Review inputs and scope; not independent efficacy.
- MHRA: opioid combination warning — Respiratory depression, monitoring and immediate help.
- NHS: insomnia assessment — Underlying causes, CBT and sleep habits.
- NHS: anaphylaxis — Immediate serious-allergy action.
- NHS: suicidal thoughts — Immediate danger versus prompt professional support.
- SPS: benzodiazepines and breastfeeding — Assessment boundary and no bedsharing; not a loprazolam safety clearance.
- NICE NG215: withdrawal care — Agreed review, adaptable withdrawal and symptom assessment.
- McAlpine et al.: 1984 hospital trial — Historical design/money only; outcomes excluded.
- Pan et al.: 2023 insomnia review — Evidence-source mapping; no independent pooled ranking adopted.
- France: Havlane product documents — Brand identity, pharmacology and behaviour warnings.
- South Africa: Dormonoct PI — Brand and adverse-effect context; no foreign regimen copied.
- Zentiva UK: legal identity — UK licence-holder identity only.
- Zentiva UK: control statement — Statutory trace boundary, separate from completed GTCR deal.
- Zentiva UK: FY 2025 accounts — Dated financial route and post-year ownership event.
- Zentiva/GTCR: completed acquisition — Current declared backing, distinct from 2025 accounts.
- Zentiva: own company contacts — Headquarters/legal-country context.
- GTCR: dated capital route — Backer-capital route only.
- Opella Poland: own legal notice — Manufacturer/group link; no Dulcobis efficacy used.
- Opella: 30 April 2025 closing — Manufacturer-group backers, distinct from Zentiva.
- Opella: transaction lawyer’s financing disclosure — Documented acquisition debt route; not inferred label payment.
- Sanofi: June 2026 prospectus — Later dated stake disclosure; no Dormonoct transfer inferred.
Educational research reviewed 5 October 2026. Diagnosis and treatment require a qualified clinician; this article does not provide an individual prescription or replace urgent assessment.
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