Fluvoxamine: Independent Evidence on OCD, Depression, Interactions & Withdrawal

Table of contents

• Evidence summary
• What fluvoxamine is
• How it works
• What it is prescribed for
• What works and what does not
• Benefits by claim
• Risks and all side effects
• All interactions
• Who should avoid fluvoxamine
• Dosage and how to take it
• Follow the money: who makes it and who funded the evidence
• Related research
• Frequently asked questions
• Sources and funding notes

Evidence summary

The table below grades the main claims about fluvoxamine. Independent sources are listed first where they exist.

Independent evidence and credibility scorecard

Tier 1 means the most independent source: regulators, or government-funded or unfunded academic work with no drug-company money in the analysis. Tier 4 means manufacturer-run analyses. Credibility A–D combines independence with methodological quality.

What fluvoxamine is

Fluvoxamine maleate is a selective serotonin reuptake inhibitor (SSRI) (Faverin SmPC). It comes as tablets, and in the US also as extended-release capsules (FDA label). It is a prescription-only medicine in both the UK and the US.

Brand names. The UK brand is Faverin (50 mg and 100 mg film-coated tablets). The current UK marketing authorisation holder is Viatris Products Limited, and the text was last revised in February 2026 (Faverin 50 mg SmPC; Faverin 100 mg SmPC). In the US the brand is Luvox. A later extended-release capsule, Luvox CR, was approved in 2008. The application is held by Jazz Pharmaceuticals and the product is now listed as discontinued (Drugs@FDA, NDA 022033).

History and originator. Fluvoxamine came from the Dutch pharmaceutical arm of the Belgian Solvay group, Solvay Duphar. A 1995 pharmacokinetic overview was written by the Department of Clinical Pharmacology at Solvay Duphar BV in Weesp, the Netherlands (van Harten, Clin Pharmacokinet 1995). Solvay's Luvox tablets (NDA 020243) were approved by the FDA as a new molecular entity on 5 December 1994 (Drugs@FDA, NDA 020243). The date of discovery and of its first European launch were not confirmed in a primary source we could fetch.

Generic status. Fluvoxamine is off-patent. In the US it is sold mainly as generic tablets and extended-release capsules from several manufacturers, and the FDA's DailyMed database lists multiple generic labels (example generic label). A branded Luvox tablet application (NDA 021519) is now held by ANI Pharmaceuticals (Drugs@FDA, NDA 021519). There is no NHS patient medicine page for fluvoxamine, which reflects how rarely it is used compared with sertraline or citalopram.

How it works

The FDA label describes the mechanism in OCD as "presumed to be linked to its specific serotonin reuptake inhibition in brain neurons" (FDA label). The UK SmPC adds that there is "minimum interference with noradrenergic processes". It also says fluvoxamine has negligible binding to adrenergic, histamine, muscarinic, dopamine or serotonin receptors, which is why it causes fewer anticholinergic effects such as dry mouth and constipation than older tricyclics (Faverin SmPC). Some researchers have also studied fluvoxamine's action at the sigma-1 receptor, which was the rationale for testing it in COVID-19 (Lenze et al., JAMA 2020). Whether that action matters clinically has not been established.

Why it interacts with so much. Fluvoxamine is "a potent inhibitor of CYP1A2 and CYP2C19", with moderate inhibition of CYP2C9, CYP2D6 and CYP3A4 (Faverin SmPC). CYP1A2 is the main enzyme that clears caffeine, theophylline, clozapine, tizanidine, ramelteon and melatonin. When fluvoxamine blocks it, those drugs build up. The Canadian CANMAT guideline singles out fluvoxamine as an exception among SSRIs because it is "a potent inhibitor of CYP1A2, CYP2C19, and CYP3A4" (CANMAT 2023).

Pharmacokinetics. Absolute bioavailability is about 53% because of first-pass metabolism in the liver. The half-life is about 13–15 hours after a single dose and 17–22 hours with repeated dosing. Steady state is reached within 10–14 days (Faverin SmPC). Levels rise disproportionately at higher doses: in a US dose-proportionality study, average peak concentrations were 88, 283 and 546 ng/mL at 100, 200 and 300 mg/day (FDA label). Smokers metabolise it about 25% faster, and older people clear it about 50% more slowly (FDA label).

What it is prescribed for

NICE also advises that SNRIs such as venlafaxine, tricyclics other than clomipramine, and MAOIs "should not normally be used" to treat OCD without comorbidity. If one SSRI fails, NICE suggests a different SSRI or clomipramine (NICE CG31).

What works and what does not

Benefits by claim

Obsessive-compulsive disorder: the strongest case for fluvoxamine

OCD is where fluvoxamine is most often used and where the regulatory evidence sits: the US label rests entirely on OCD trials. In the two 10-week US adult trials, patients started with a mean Y-BOCS score of 23 (moderate to severe). Their scores fell by about 4 to 5 points on fluvoxamine vs about 2 points on placebo. Among completers, 43% were rated "much" or "very much" improved on fluvoxamine vs 12% on placebo (FDA label). These are manufacturer trials reviewed by the FDA, and completer analyses tend to flatter results because people who drop out are left out.

The independent picture agrees on direction. The Cochrane review by Soomro and colleagues (17 trials, 3,097 people; authors declared no conflicts) found SSRIs as a group reduced Y-BOCS scores by 3.21 points more than placebo, with an 84% relative increase in the chance of responding (RR 1.84). The difference between individual SSRIs was "not statistically different" (Soomro et al., Cochrane 2008). In the NIHR-funded network meta-analysis by Skapinakis and colleagues, SSRIs as a class improved Y-BOCS scores by 3.49 points, and clomipramine was "not better" than SSRIs. Behavioural and cognitive therapy showed larger effects, but most therapy trials allowed patients to stay on antidepressants, which the authors called "a serious limitation". They concluded that combining therapy with medication is likely to beat therapy alone, "at least in severe obsessive-compulsive disorder" (Skapinakis et al., Lancet Psychiatry 2016).

What this means in practice. On a 40-point scale, a 3 to 5 point average gain over placebo is real but moderate. Many people improve partially rather than fully. NICE notes a delay in the onset of effect of up to 12 weeks in OCD. It advises reviewing if there is no adequate response within 12 weeks and continuing an effective SSRI for at least 12 months (NICE CG31). There is no good evidence that fluvoxamine is better or worse than sertraline, fluoxetine or paroxetine for OCD. Choosing between them usually comes down to side effects, interactions and the other medicines a person takes.

Depression: effective, but not a front-runner

The most comprehensive independent estimate comes from Cipriani 2018, funded by the UK NIHR and the Japan Society for the Promotion of Science. The funder had "no role". It pooled 522 trials, 409 (78%) of which were funded by drug companies. Fluvoxamine's odds ratio for response vs placebo was 1.69 (95% CrI 1.41–2.02), in the middle of the 21 drugs. Its dropout odds ratio was 1.10 (0.91–1.33), not significantly different from placebo (Cipriani 2018, figure 3). In direct head-to-head comparisons, however, fluvoxamine was one of the four "least efficacious drugs" (with fluoxetine, reboxetine and trazodone). It was also one of the seven with "the highest dropout rates". The authors concluded that reboxetine, trazodone and fluvoxamine "were associated with generally inferior efficacy and acceptability profiles compared with the other antidepressants, making them less favourable options" (Cipriani et al., Lancet 2018).

A Cochrane review focused only on fluvoxamine (54 trials, 5,122 people) was less harsh. It found "no strong evidence" that fluvoxamine was better or worse than other antidepressants in efficacy and tolerability, though it caused more nausea and vomiting than imipramine and clomipramine (Omori et al., Cochrane 2010). These two findings are compatible: the differences between antidepressants are small, and wide uncertainty intervals make rankings fragile.

Placebo response and clinical significance. Across antidepressants, an FDA staff analysis of 232 trials found an average advantage over placebo of 1.75 points on the 17-item Hamilton scale, larger in more severe depression (Stone et al., BMJ 2022). An odds ratio of 1.69 is the extra benefit on top of a placebo group that also improves substantially. NICE advises that benefits "should be felt within 4 weeks" and that treatment usually continues for at least 6 months after remission (NICE NG222). The UK SmPC also asks that people with depression be treated for "at least 6 months" (Faverin SmPC).

COVID-19: a lesson in how early results can mislead

Fluvoxamine drew worldwide attention in 2020–2022 as a possible cheap COVID-19 treatment. The sequence of trials is instructive:

• STOP COVID (2020): 152 US outpatients. Clinical deterioration occurred in 0 of 80 on fluvoxamine 100 mg three times daily vs 6 of 72 on placebo. The authors called it "preliminary" and "limited by a small sample size and short follow-up duration". One author declared consulting fees from Jazz Pharmaceuticals, a former Luvox CR marketer, among other interests (Lenze et al., JAMA 2020).
• TOGETHER (Brazil, 2022): 741 on fluvoxamine 100 mg twice daily vs 756 on placebo, all high-risk. The primary composite (more than 6 hours in a COVID emergency setting, or hospital transfer) occurred in 11% vs 16% (RR 0.68, 95% BCI 0.52–0.88). Deaths were 17 vs 25 (OR 0.68, 95% CI 0.36–1.27, not significant). Funded by Fast Grants and the Rainwater Charitable Foundation (Reis et al., Lancet Glob Health 2022).
• COVID-OUT (US, 2022): 1,323 analysed. Adjusted OR for the primary outcome with fluvoxamine was 0.94 (95% CI 0.66–1.36). The authors concluded that none of the three drugs tested prevented serious outcomes (Bramante et al., NEJM 2022).
• ACTIV-6, 50 mg twice daily (US, 2023): 1,288 completed. Median time to sustained recovery was 12 vs 13 days (HR 0.96, 95% CrI 0.86–1.06). The findings "do not support the use of fluvoxamine at this dose and duration" (McCarthy et al., JAMA 2023).
• ACTIV-6, 100 mg twice daily (US, 2023): 1,175 analysed. Adjusted HR for recovery was 0.99 (95% CrI 0.89–1.09), with a median of 10 days in both groups. Fluvoxamine "does not reduce duration of COVID-19 symptoms" (Stewart et al., JAMA 2023).

In May 2022 the FDA declined an emergency use authorisation requested by an academic investigator. It noted that the TOGETHER result "was primarily driven by a reduction in the emergency department visits lasting greater than 6 hours" and that the benefit "was not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and deaths". It also noted that two other trials had been stopped early for futility (FDA decision memo). Pure City Research's reading: there is no reliable evidence that fluvoxamine treats COVID-19. It should not be taken for this purpose, especially given its interaction burden.

Risks and all side effects

Common side effects

Pooled US placebo-controlled trials in adults with OCD and depression (892 on fluvoxamine, 778 on placebo) give the clearest comparison. Selected reactions more common on fluvoxamine (FDA label, Table 2):

Of 1,087 patients treated in North American controlled trials, 22% stopped because of an adverse reaction. The commonest reasons were nausea (9%), insomnia (4%) and somnolence (4%) (FDA label). The UK SmPC notes that nausea, sometimes with vomiting, "usually diminishes within the first two weeks of treatment" (Faverin SmPC). The label warns that sexual side-effect rates in product labelling "are likely to underestimate their actual incidence", because patients and doctors often do not discuss them (FDA label).

Serious and important risks

Withdrawal (discontinuation) symptoms

The UK SmPC reports that in clinical trials, adverse events on stopping occurred in approximately 12% of fluvoxamine patients, "similar to the incidence seen in patients taking placebo". It lists dizziness, sensory disturbances including "electric shock sensations", sleep disturbances and intense dreams, agitation, irritability, confusion, nausea, sweating, palpitations, headache and tremor. These usually resolve within 2 weeks, "though in some individuals they may be prolonged (2-3 months or more)". The SmPC advises tapering "over a period of several weeks or months, according to the patient's needs" (Faverin SmPC).

For context across all antidepressants, the unfunded Henssler 2024 meta-analysis (79 studies, 21,002 patients) found at least one discontinuation symptom in 31% after stopping an antidepressant vs 17% after stopping placebo. That gives a placebo-adjusted incidence of "approximately 15%". Severe symptoms occurred in 2.8% vs 0.6%. Fluvoxamine was not among the drugs it singled out for higher frequency or severity (Henssler et al., Lancet Psychiatry 2024). A review with a withdrawal-focused author team estimated a much higher weighted average of 56% across antidepressants (Davies & Read, 2019). CANMAT classes fluvoxamine as a "moderate risk" antidepressant for discontinuation symptoms, with paroxetine and venlafaxine as "high risk" (CANMAT 2023).

One discontinuation problem is specific to fluvoxamine: when it is stopped, the drugs it was holding at high levels can drop. The FDA label reports opioid withdrawal symptoms after fluvoxamine was stopped in a patient on methadone (FDA label). The same logic applies to clozapine and other drugs whose doses were lowered to allow for fluvoxamine.

Dependence

Fluvoxamine is not a controlled substance. The UK SmPC reports that a non-human primate study found "no evidence of dependency phenomena" (Faverin SmPC). The body can still adapt to it, which is why stopping suddenly can cause withdrawal symptoms. This is physical adaptation, not addiction.

Overdose

The UK SmPC states that fluvoxamine "has a wide margin of safety in overdose" and that deaths from fluvoxamine alone have been "extremely rare". The highest documented ingestion was 12 grams, and that patient recovered (Faverin SmPC). The US label lists seizures (which may be delayed), coma, QRS and QTc prolongation, blood pressure changes and serotonin syndrome in overdose (FDA label). Mixed overdoses with other drugs are more dangerous.

All interactions

This is the most important section for anyone taking fluvoxamine. The table combines the US label and UK SmPC. It is not a substitute for a pharmacist's full interaction check.

Who should avoid fluvoxamine

• Contraindicated: anyone taking tizanidine, pimozide, an MAOI (or within the washout period), or, in the US, thioridazine or alosetron. Also anyone allergic to fluvoxamine or an ingredient (SmPC; FDA label).
• People on many other medicines: anyone taking clozapine, theophylline, warfarin, methadone, oxidised benzodiazepines, carbamazepine, phenytoin or clopidogrel needs specialist review first. Another SSRI with fewer interactions may be simpler.
• Caution needed: epilepsy (avoid if unstable), a history of mania, bleeding disorders, narrow-angle glaucoma, diabetes, and recent heart attack, where the SmPC notes a "lack of clinical experience" (SmPC).
• Children and adolescents: licensed for OCD from age 8, but not for depression. Growth and weight should be monitored (FDA label).
• Pregnancy: the UK SmPC says Faverin "should not be used during pregnancy unless the clinical condition of the woman requires treatment". It notes an SSRI-associated risk of persistent pulmonary hypertension of the newborn of about 5 per 1,000 pregnancies, vs 1–2 per 1,000 in the general population (SmPC). The US label says decades of observational data "have not identified a clear drug-associated risk of major birth defects or miscarriage". It also warns of newborn complications after late-pregnancy exposure and cites evidence that stopping antidepressants in pregnancy raises relapse risk (FDA label). Do not stop suddenly on finding you are pregnant. Speak to your prescriber.
• Breastfeeding: the two regulators differ. The UK SmPC says fluvoxamine is excreted in small quantities and "should not be used by women who breast feed" (SmPC). The US label says most reports showed no adverse effects in infants, but advises monitoring for diarrhoea, vomiting, reduced sleep and agitation (FDA label).
• Fertility: animal studies showed impaired fertility. The UK SmPC advises against use in people trying to conceive unless their condition requires it (SmPC).
• Older adults: clearance is about 50% lower and half-life longer, so a lower starting dose and slower titration are advised. There is also a higher risk of hyponatraemia (FDA label). Note: we could not access the full 2023 AGS Beers Criteria tables during this review, so no Beers-specific wording is given here.
• Liver impairment: clearance is reduced (about 30% in one comparison), so start low and titrate slowly (FDA label; SmPC).
• Kidney impairment: the UK SmPC advises starting on a low dose with careful monitoring (SmPC).

Dosage and how to take it

Sources: Faverin SmPC; FDA label. The UK SmPC notes that "no formal clinical trials were conducted investigating the dose response of fluvoxamine". Because levels rise disproportionately at higher doses, and interactions get stronger, dose increases should be made cautiously.

How to take it

• Swallow tablets with water, without chewing (SmPC). Food does not affect absorption (FDA label).
• Single doses are usually taken in the evening or at bedtime.
• Show your full medicines list, including supplements and melatonin, to a pharmacist before starting.

How long before it works

For depression, NICE says benefits usually appear within 4 weeks if the antidepressant is going to work (NICE NG222). For OCD, NICE describes "a delay in the onset of effect of up to 12 weeks". If an SSRI works for OCD, it should be continued for at least 12 months (NICE CG31).

How to stop safely

Do not stop suddenly. The UK SmPC advises reducing the dose over at least one or two weeks. It adds that tapering should be "over a period of several weeks or months, according to the patient's needs". If intolerable symptoms occur, the prescriber may return to the previous dose and reduce more slowly (SmPC). NICE's depression guideline recommends step-wise reductions, each a proportion of the previous dose (for example 50%), with smaller steps (for example 25%) at lower doses. It advises allowing 1 to 2 weeks to judge each step (NICE NG222). For OCD, NICE advises tapering "gradually over several weeks according to the person's need" (NICE CG31). If you take clozapine, methadone, theophylline, warfarin or another interacting drug, your prescriber will also need to review that drug's dose as fluvoxamine is reduced.

Follow the money: who makes it and who funded the evidence

Originator and current owners

• Originator: Solvay Duphar (Weesp, the Netherlands), part of the Belgian Solvay group. Early pharmacology came from Solvay Duphar's clinical pharmacology department (van Harten 1995). Solvay Pharmaceuticals held the original US Luvox approval of 5 December 1994 (Drugs@FDA).
• Abbott (US). In February 2010 Abbott completed its €4.5 billion ($6.2 billion) acquisition of "Belgium-based Solvay Pharmaceuticals" (Abbott press release, 2010).
• Mylan, then Viatris. In February 2015 Mylan completed its acquisition of Abbott's "non-U.S. developed markets specialty and branded generics business", reorganised under Mylan N.V. in the Netherlands (Mylan SEC 8-K exhibit, 2015). Mylan combined with Pfizer's Upjohn business in 2020 to form Viatris (SEC 8-K, 2020). Viatris Products Limited now holds the UK Faverin licence (SmPC). These filings do not name Faverin specifically, so the exact route by which the UK licence moved is inferred from the current holder rather than documented line by line.
• US brands. Luvox CR (approved 2008) is held by Jazz Pharmaceuticals and is now discontinued (Drugs@FDA, NDA 022033). A Luvox tablet application (NDA 021519, approved 2007) is listed under ANI Pharmaceuticals (Drugs@FDA, NDA 021519).
• Generics and revenue. Most fluvoxamine sold today is generic. We found no current brand-level revenue figure for fluvoxamine in any filing we checked. The commercial stakes today are small compared with patent-protected antidepressants.

Documented integrity event: the 2002–2003 US Luvox withdrawal

In 2003 the FDA formally withdrew approval of Solvay's original Luvox tablet application. According to the Federal Register notice, Solvay "voluntarily withdrawn these NDAs in response to audit findings indicating possible inaccuracies noted in the chemistry, manufacturing, and controls (CMC) section". Solvay requested withdrawal in letters dated March and May 2002 and "also withdrew these drug products from the market". The FDA determined that Luvox "was not withdrawn from sale for reasons of safety or effectiveness", which allowed generic versions to continue (Federal Register, 3 September 2003). This was a manufacturing-documentation problem, not a finding that the drug was unsafe or ineffective.

Who funded the evidence

• Licensing trials: run by the original manufacturer. The US OCD and depression trial data in the label come from Solvay's programme, reviewed by the FDA (FDA label).
• Independent syntheses: Cipriani 2018 (NIHR and JSPS), Skapinakis 2016 (NIHR), Soomro 2008 and Omori 2010 (Cochrane, academic) and Henssler 2024 (unfunded). These confirm fluvoxamine works for OCD as an SSRI and for depression. They give no support to any claim that it beats other SSRIs, and Cipriani ranks it unfavourably for depression. Cipriani notes that 78% of the trials it pooled were drug-company funded (Cipriani 2018). In Omori's Cochrane review, one author (Furukawa) declared fees from companies including Meiji. Pure City Research could not confirm from a fetched primary source whether Meiji markets fluvoxamine in Japan, so we note the declaration without drawing a conclusion (Omori 2010).
• COVID-19 trials: funded by philanthropy (TOGETHER: Fast Grants and the Rainwater Charitable Foundation) and US government grants (COVID-OUT and ACTIV-6: NIH institutes). No manufacturer sponsored them. Declared interests include one STOP COVID author's consulting fees from Jazz Pharmaceuticals, and a COVID-OUT and ACTIV-6 investigator's "research support from Apotex", a generic drug company. We did not establish that either interest related to fluvoxamine (Lenze 2020; McCarthy 2023).

Related research

• Stress, anxiety and depression: prevention and management guide
• Supplements for stress, anxiety and depression: the evidence
• Melatonin: avoid combining with fluvoxamine, which raises melatonin levels many-fold
• St John's wort: do not combine with SSRIs
• Saffron for depression
• L-theanine
• Magnesium
• Sleep prevention guide (insomnia and drowsiness are common on fluvoxamine)
• Sleep supplements evidence
• Sibling medicine reviews: sertraline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, desvenlafaxine, alprazolam, diazepam

Frequently asked questions

Sources and funding notes

• Faverin 50 mg SmPC (emc) and Faverin 100 mg SmPC: licence holder (Viatris Products Ltd) text approved by the UK regulator. Revised February 2026.
• Fluvoxamine maleate tablets prescribing information (DailyMed / FDA): generic label approved by the US FDA. Efficacy data come from the originator's trials.
• Drugs@FDA NDA 020243, NDA 021519 and NDA 022033: US government approval records.
• Federal Register, 3 September 2003 (Luvox NDA withdrawal): US government.
• NICE CG31, OCD and body dysmorphic disorder (2005): UK government-funded guideline body.
• NICE NG222, Depression in adults (2022): UK government-funded.
• WHO mhGAP guideline (2023): World Health Organization. Written declarations of interest; most panel members declared none.
• Cipriani et al., Lancet 2018 (full text): NIHR Oxford Health BRC (UK) and JSPS (Japan), with no funder role. Some authors declared pharma fees.
• Soomro et al., Cochrane 2008 (SSRIs vs placebo for OCD): St George's, University of London (UK). Authors declared no conflicts.
• Skapinakis et al., Lancet Psychiatry 2016 (OCD network meta-analysis): UCL (UK) and University of Ioannina (Greece). Funded by NIHR.
• Omori et al., Cochrane 2010 (fluvoxamine vs other antidepressants): Nagoya City University (Japan). One author declared fees from Dai Nippon Sumitomo, Eli Lilly, GSK, Meiji, Otsuka and Pfizer, plus Japanese government research funding; another declared a GSK speaking fee.
• Lenze et al., JAMA 2020 (STOP COVID): Washington University in St Louis (US). Authors declared various industry ties, including consulting for Jazz Pharmaceuticals.
• Reis et al., Lancet Glob Health 2022 (TOGETHER): Brazil and McMaster University (Canada). Funded by Fast Grants and the Rainwater Charitable Foundation.
• Bramante et al., NEJM 2022 (COVID-OUT): University of Minnesota (US). Parsemus Foundation and US NIH grants.
• McCarthy et al., JAMA 2023 (ACTIV-6, 50 mg) and Stewart et al., JAMA 2023 (ACTIV-6, 100 mg): US NIH-funded platform trial. Several investigators declared unrelated industry ties.
• FDA memorandum declining the fluvoxamine EUA (2022): US regulator.
• Henssler et al., Lancet Psychiatry 2024: University of Cologne and Charité Berlin (Germany). No funding and no competing interests.
• Davies & Read, Addict Behav 2019: UK universities. Authors list affiliations with withdrawal-advocacy bodies.
• CANMAT 2023 depression guideline (Lam et al., 2024): Canada. Internal funds, with no industry funding for the guideline. Many authors declared industry grants or fees.
• Culm-Merdek et al., Br J Clin Pharmacol 2005 (caffeine): Tufts University (US). US NIH grants.
• Christensen et al., Clin Pharmacol Ther 2002 (low-dose CYP inhibition): Karolinska Institutet (Sweden). US NIGMS grant listed.
• Stone et al., BMJ 2022: FDA staff analysis of trial data submitted to the FDA. No external funding.
• van Weringh et al., Eur J Drug Metab Pharmacokinet 2026 (clozapine): Dutch clinical study. Authors declared no conflicts.
• Härtter et al., J Clin Psychopharmacol 2001 (melatonin metabolism): University of Mainz (Germany) laboratory study. Funding not stated in the abstract.
• Circadin (prolonged-release melatonin) SmPC, EMA: EU-approved product information.
• EMA PRAC, May 2019 (persistent sexual dysfunction wording): EU regulator.
• van Harten, Clin Pharmacokinet 1995: written by an employee of Solvay Duphar BV (Netherlands), the originator.
• Abbott, "Abbott Completes Acquisition of Solvay Pharmaceuticals" (2010): company press release.
• Mylan SEC 8-K exhibit 99.1 (27 February 2015) and SEC 8-K on the formation of Viatris (2020): company filings.

Last reviewed: 26 September 2026. Educational information from Pure City Research, not medical advice. Medicine decisions belong with a qualified prescriber.