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Sertindole appears effective as an antipsychotic in schizophrenia.¹ In a 2013 study in a comparison of 15 antipsychotic drugs in effectivity in treating schizophrenic symptoms, sertindole was found to be slightly less effective than haloperidol, quetiapine, and aripiprazole, as effective as ziprasidone, approximately as effective as chlorpromazine and asenapine, and slightly more effective than lurasidone and iloperidone.²

Adverse effects

Very common (>10% incidence) adverse effects include:³

• Headache
• Ejaculation failure
• Insomnia
• Dizziness

Common (1–10% incidence) adverse effects include:⁴

• Urine that tests positive for red and/or white blood cells
• Sedation (causes less sedation than most antipsychotic drugs according to a recent meta-analysis of the efficacy and tolerability of 15 antipsychotic drugs. Causes only slightly [and non-significantly] more sedation than amisulpride and paliperidone)⁵⁶
• Ejaculation disorder
• Erectile dysfunction
• Orthostatic hypotension⁷
• Weight gain (which it seems to possess a similar propensity for causing as quetiapine)⁸

Uncommon (0.1–1% incidence) adverse effects include:⁹

• Substernal chest pain
• Face oedema
• Influenza-like illness
• Neck rigidity
• Pallor
• Peripheral vascular disorder
• syncope
• Torsades de pointes
• Vasodilation
• Suicide attempt
• Amnesia
• Anxiety
• Ataxia
• Confusion
• Incoordination
• Libido decreased
• Libido increased
• Miosis
• Nystagmus
• Personality disorder
• Psychosis
• Reflexes decreased
• Reflexes increased
• Stupor
• Suicidal tendency
• Urinary retention
• Vertigo
• Diabetes mellitus
• Abnormal stools
• Gastritis
• Gingivitis
• Glossitis
• Increased appetite
• Mouth ulceration
• Rectal disorder
• Rectal haemorrhage
• Stomatitis
• Tongue disorder
• Ulcerative stomatitis
• Anaemia
• Ecchymosis
• Hypochromic anaemia
• Leukopenia
• Hyperglycaemia
• Hyperlipemia
• Oedema
• Bone pain
• Myasthenia
• Twitching
• Bronchitis
• Hyperventilation
• Pneumonia
• Sinusitis
• Furunculosis
• Herpes simplex
• Nail disorder
• Psoriasis
• Pustular Rash
• Skin discolouration
• Skin hypertrophy
• Skin ulcer
• Abnormal vision
• Keratoconjunctivitis
• Lacrimation disorder
• Otitis externa
• Pupillary disorder
• Taste perversion
• Anorgasmia
• Penis disorder (gs)
• Urinary urgency
• Hyperprolactinaemia (which it seems to cause with a higher propensity than most other atypical antipsychotics do)¹⁰
• Seizures
• Galactorrhoea

Rare (<0.1% incidence) adverse effects include:¹¹

• Neuroleptic malignant syndrome
• Tardive dyskinesia

Unknown frequency adverse events include:¹²

• Extrapyramidal side effects (EPSE; e.g. dystonia, akathisia, muscle rigidity, parkinsonism, etc. These adverse effects are probably uncommon/rare according to a recent meta-analysis of the efficacy and tolerability of 15 antipsychotic drugs which found it had the 2nd lowest effect size for causing EPSE)¹³
• Venous thromboembolism
• QT interval prolongation (probably common; in a recent meta-analysis of the efficacy and tolerability of 15 antipsychotic drugs it was found to be the most prone to causing QT interval prolongation)¹⁴

Pharmacology

Sertindole is metabolized in the body to dehydrosertindole.²¹

Safety and status

United States

Abbott Labs first applied for U.S. Food and Drug Administration (FDA) approval for sertindole in 1996,²² but withdrew this application in 1998 following concerns over the increased risk of sudden death from QTc prolongation.²³ In a trial of 2000 patients on taking sertindole, 27 patients died unexpectedly, including 13 sudden deaths.²⁴ Lundbeck cites the results of the Sertindole Cohort Prospective (SCoP) study of 10,000 patients to support its claim that although sertindole does increase the QTc interval, this is not associated with increased rates of cardiac arrhythmias, and that patients on sertindole had the same overall mortality rate as those on risperidone.²⁵ Nevertheless, in April 2009 an FDA advisory panel voted 13-0 that sertindole was effective in the treatment of schizophrenia but 12-1 that it had not been shown to be acceptably safe.²⁶ As of October 2010[update], the drug has not been approved by the FDA for use in the USA.²⁷

European Union

In the European Union, sertindole was approved and marketed in 19 countries from 1996,²⁸ but its marketing authorization was suspended by the European Medicines Agency in 1998²⁹ and the drug was withdrawn from the market. In 2002, based on new data, the EMA's CHMP suggested that Sertindole could be reintroduced for restricted use in clinical trials, with strong safeguards including extensive contraindications and warnings for patients at risk of cardiac dysrhythmias, a recommended reduction in maximum dose from 24 mg to 20 mg in all but exceptional cases, and extensive ECG monitoring requirement before and during treatment.³⁰³¹ As of September 2020[update], sertindole is authorized in several countries of the European Union.³²

References

1. Lewis R, Bagnall AM, Leitner M (July 2005). "Sertindole for schizophrenia". The Cochrane Database of Systematic Reviews. 2005 (3): CD001715. doi:10.1002/14651858.CD001715.pub2. PMC 7025766. PMID 16034864. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7025766 ↩

2. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, et al. (September 2013). "Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis". Lancet. 382 (9896): 951–62. doi:10.1016/S0140-6736(13)60733-3. PMID 23810019. S2CID 32085212. /wiki/Doi_(identifier) ↩

3. "PRODUCT INFORMATION SERDOLECT TABLETS" (PDF). TGA eBusiness Services. Lundbeck Australia Pty Ltd. 16 January 2013. Retrieved 27 October 2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07697-3 ↩

4. "PRODUCT INFORMATION SERDOLECT TABLETS" (PDF). TGA eBusiness Services. Lundbeck Australia Pty Ltd. 16 January 2013. Retrieved 27 October 2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07697-3 ↩

5. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, et al. (September 2013). "Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis". Lancet. 382 (9896): 951–62. doi:10.1016/S0140-6736(13)60733-3. PMID 23810019. S2CID 32085212. /wiki/Doi_(identifier) ↩

6. Taylor D, Paton C, Shitij K (2012). The Maudsley prescribing guidelines in psychiatry. West Sussex: Wiley-Blackwell. ISBN 978-0-470-97948-8. 978-0-470-97948-8 ↩

7. Taylor D, Paton C, Shitij K (2012). The Maudsley prescribing guidelines in psychiatry. West Sussex: Wiley-Blackwell. ISBN 978-0-470-97948-8. 978-0-470-97948-8 ↩

8. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, et al. (September 2013). "Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis". Lancet. 382 (9896): 951–62. doi:10.1016/S0140-6736(13)60733-3. PMID 23810019. S2CID 32085212. /wiki/Doi_(identifier) ↩

9. "PRODUCT INFORMATION SERDOLECT TABLETS" (PDF). TGA eBusiness Services. Lundbeck Australia Pty Ltd. 16 January 2013. Retrieved 27 October 2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07697-3 ↩

10. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, et al. (September 2013). "Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis". Lancet. 382 (9896): 951–62. doi:10.1016/S0140-6736(13)60733-3. PMID 23810019. S2CID 32085212. /wiki/Doi_(identifier) ↩

11. "PRODUCT INFORMATION SERDOLECT TABLETS" (PDF). TGA eBusiness Services. Lundbeck Australia Pty Ltd. 16 January 2013. Retrieved 27 October 2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07697-3 ↩

12. "PRODUCT INFORMATION SERDOLECT TABLETS" (PDF). TGA eBusiness Services. Lundbeck Australia Pty Ltd. 16 January 2013. Retrieved 27 October 2013. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07697-3 ↩

13. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, et al. (September 2013). "Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis". Lancet. 382 (9896): 951–62. doi:10.1016/S0140-6736(13)60733-3. PMID 23810019. S2CID 32085212. /wiki/Doi_(identifier) ↩

14. Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, et al. (September 2013). "Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis". Lancet. 382 (9896): 951–62. doi:10.1016/S0140-6736(13)60733-3. PMID 23810019. S2CID 32085212. /wiki/Doi_(identifier) ↩

15. Roth BL, Driscol J (12 January 2011). "PDSP Ki Database". Psychoactive Drug Screening Program (PDSP). University of North Carolina at Chapel Hill and the United States National Institute of Mental Health. Archived from the original on 8 November 2013. Retrieved 27 October 2013. /wiki/Bryan_Roth ↩

16. Brunton L, Chabner B, Knollman B (2010). Goodman and Gilman's The Pharmacological Basis of Therapeutics (12th ed.). New York: McGraw-Hill Professional. ISBN 978-0-07-162442-8. 978-0-07-162442-8 ↩

17. Brunton L, Chabner B, Knollman B (2010). Goodman and Gilman's The Pharmacological Basis of Therapeutics (12th ed.). New York: McGraw-Hill Professional. ISBN 978-0-07-162442-8. 978-0-07-162442-8 ↩

18. Brunton L, Chabner B, Knollman B (2010). Goodman and Gilman's The Pharmacological Basis of Therapeutics (12th ed.). New York: McGraw-Hill Professional. ISBN 978-0-07-162442-8. 978-0-07-162442-8 ↩

19. Brunton L, Chabner B, Knollman B (2010). Goodman and Gilman's The Pharmacological Basis of Therapeutics (12th ed.). New York: McGraw-Hill Professional. ISBN 978-0-07-162442-8. 978-0-07-162442-8 ↩

20. Brunton L, Chabner B, Knollman B (2010). Goodman and Gilman's The Pharmacological Basis of Therapeutics (12th ed.). New York: McGraw-Hill Professional. ISBN 978-0-07-162442-8. 978-0-07-162442-8 ↩

21. "TRC | Details of CAS = 173294-84-3, ChemicalName = Dehydrosertindole, synonym = 1-[2-[4-[5-Chloro-1-(4-fluorophenyl)-1H-indol-3-yl]-1-piperidinyl]ethyl]-1,3-dihydro-2H-Imidazol-2-one; Lu 28-092, MolFormula = C24H24ClFn4O". Archived from the original on 27 April 2015. Retrieved 20 April 2015. https://web.archive.org/web/20150427111632/http://www.trc-canada.com/detail.php?CatNum=D230095&CAS=173294-84-3&Chemical_Name=Dehydrosertindole&Mol_Formula=C24H24ClFN4O&Synonym=1-%5B2-%5B4-%5B5-Chloro-1-(4-fluorophenyl)-1H-indol-3-yl%5D-1-piperidinyl%5Dethyl%5D-1,3-dihydro-2H-Imidazol-2-one;%20Lu%2028-092 ↩

22. Zeneca's Seroquel Nears Market Approval - The Pharma Letter, 16 July 1997 http://www.thepharmaletter.com/file/57165/zenecas-seroquel-nears-market-approval.html ↩

23. Abbott Labs Withdraws Sertindole NDA Sertindole - The Pharma Letter, 12 January 1998 http://www.thepharmaletter.com/file/65187/abbott-labs-withdraws-sertindole-nda.html ↩

24. "WHO Pharmaceuticals Newsletter 1998, No. 03&04: Regulatory actions: Sertindole - approval application withdrawn". Archived from the original on 22 June 2011. https://web.archive.org/web/20110622124240/http://apps.who.int/medicinedocs/en/d/Js2256e/1.12.html#Js2256e.1.12 ↩

25. FDA Advisory Committee provides opinion on Serdolect for the treatment of schizophrenia Archived 14 July 2011 at the Wayback Machine - Lundbeck press release, 8 April 2009 http://sweden.lundbeck.com/investor/releases/ReleaseDetails/Release_1304142_EN.asp ↩

26. Food and Drug Administration; Minutes of the Psychphamacological Drugs Advisory Committee, 7 Apr 2009 https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM198218.pdf ↩

27. "Welcome to Lundbeck's global site". http://www.serdolect.com ↩

28. "WHO Pharmaceuticals Newsletter 1998, No. 03&04: Regulatory actions: Sertindole - approval application withdrawn". Archived from the original on 22 June 2011. https://web.archive.org/web/20110622124240/http://apps.who.int/medicinedocs/en/d/Js2256e/1.12.html#Js2256e.1.12 ↩

29. EU CHMP recommends lifting ban on atypical antipsychotic Serdolect (sertindole) Archived 2 October 2011 at the Wayback Machine - National electronic Library for Medicines, NHS http://www.nelm.nhs.uk/en/NeLM-Area/News/483119/483386/483398/ ↩

30. COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS OPINION FOLLOWING AN ARTICLE 36 REFERRAL: SERTINDOLE Archived 4 March 2016 at the Wayback Machine - European Medicines Agency, 13 September 2002 http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Sertindole_36/WC500011855.pdf ↩

31. Restricted re-introduction of the atypical antipsychotic sertindole (Serdolect) Archived 17 November 2010 at the Wayback Machine - MHRA, 2002 http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/CON019523 ↩

32. Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/202001 (PDF) (Report). European Medicines Agency (EMA). 3 September 2020. EMA/270645/2015. https://www.ema.europa.eu/documents/psusa/sertindole-list-nationally-authorised-medicinal-products-psusa/00002695/202001_en.pdf ↩