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Qutan SR 400

Qutan SR 400 (Quetiapine 400 mg SR) — extended-release atypical for schizophrenia, bipolar mania, bipolar depression, MDD adjunct. flatter sedation peak than IR — once-daily dosing.

Ιατρικά ελεγμένο από Morgan Ellis — Pharmacy Researcher · 8 years experience  · Last reviewed: May 2026

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⚡ Quick Answer

Qutan SR 400 (Quetiapine 400 mg SR, extended/sustained-release) is an atypical antipsychotic for schizophrenia, bipolar mania, bipolar depression, MDD adjunct, and GAD adjunct. Strongly sedating and metabolically heavy — but uniquely effective for bipolar depression. Often misused as a “sleeping pill” — discouraged because of metabolic burden.

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What Qutan SR 400 is and how it works

Qutan SR 400 is a quetiapine extended/sustained-release tablet supplied by Cipla. Available strengths: 400 mg SR. Quetiapine has loose D2 binding (rapid dissociation explains low EPS), strong 5-HT2A antagonism, very strong H1 antihistamine action (sedation, weight gain), α1-adrenergic antagonism (orthostasis), and α2 antagonism. Its active metabolite, norquetiapine, has noradrenaline transporter inhibition — the basis for the antidepressant effect in bipolar depression.

The SR/XR formulation is dosed once daily, generally at bedtime. The IR formulation is split BID. SR has slightly lower peak sedation and may be better tolerated for daytime function.

Indications and dosing

IndicationStartingTargetMax
Schizophrenia (SR)50 mg HS400–800 mg/day800 mg
Bipolar mania50 mg BID (IR) or 300 mg HS (SR)400–800 mg/day800 mg
Bipolar depression50 mg HS300 mg HS600 mg
MDD adjunct (SR)50 mg HS150–300 mg HS300 mg
GAD adjunct (off-label)50 mg HS50–150 mg HS
Older adults25 mg HS50–200 mg/dayby tolerability

Important safety considerations

FDA black-box — dementia-related psychosis

All atypical antipsychotics carry an FDA black-box warning for increased mortality (mostly cardiovascular and infectious) when used to treat behavioural disturbance in older adults with dementia. Atypicals are not approved for dementia-related psychosis or agitation. Use in this population is off-label, last-resort, time-limited, and requires explicit risk-benefit conversation.

Heavy metabolic burden

Weight gain, insulin resistance, dyslipidaemia — second only to olanzapine and clozapine among atypicals. Mandatory monitoring at baseline, 12 weeks, then 6-monthly: weight, fasting glucose / HbA1c, fasting lipids, BP. Counsel about diet/exercise from initiation.

Orthostatic hypotension

α1 antagonism produces orthostatic hypotension, particularly in older adults and at initiation. Titrate slowly. Check sitting and standing BP at follow-up.

“Off-label sleep aid” — discouraged

Low-dose quetiapine (25–50 mg HS) is widely used off-label as a hypnotic. The metabolic burden is the same regardless of indication — patients on quetiapine for sleep gain weight and develop insulin resistance just as much as patients on quetiapine for psychosis. Dedicated hypnotics (Z-drugs, low-dose doxepin, melatonin agonists, behavioural sleep therapy) are usually safer choices for primary insomnia.

Suicidality (under-25, MDD adjunct use)

When used as an antidepressant adjunct, the under-25 suicidality warning applies.

Common side effects

  • Sedation — universal; harness as bedtime benefit.
  • Weight gain and metabolic syndrome — heavy.
  • Orthostatic hypotension and dizziness — common at initiation.
  • Dry mouth, constipation — moderate anticholinergic effect.
  • Tachycardia — often noticed.
  • EPS / akathisia — less common than risperidone or olanzapine.
  • Prolactin — usually normal or low.
  • QT — modest dose-dependent prolongation.

Drug interactions

  • Strong CYP3A4 inhibitors (azoles, clarithromycin, ritonavir, grapefruit juice) — raise quetiapine levels several-fold; reduce dose or avoid.
  • Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St John’s wort) — reduce levels; may need higher doses or switch.
  • Other QT-prolonging drugs — additive risk.
  • CNS depressants — strong additive sedation.
  • Antihypertensives — additive orthostasis.

Pregnancy, breastfeeding, paediatric

Pregnancy: limited data; late-pregnancy exposure can produce neonatal EPS. Breastfeeding: passes into milk in small amounts; usually compatible with monitoring. Paediatric: licensed from 13 (schizophrenia), 10 (bipolar mania).

Storage

Store at 15–30 °C in original packaging.

Frequently Asked Questions

Why is Qutan SR 400 so sedating?

Strong H1 antihistamine action plus α1-adrenergic blockade — this is the dominant pharmacology at low doses. The antipsychotic dopamine-D2 effect dominates only at higher doses. The clinical translation: 25–100 mg is mostly a sleeping pill; 200–400 mg starts to have antipsychotic effect; 600–800 mg is the antipsychotic dose range.

Is using Qutan SR 400 for sleep a good idea?

Probably not. The metabolic burden of quetiapine is identical at 25 mg and at 800 mg — patients on low-dose quetiapine for insomnia gain weight, develop insulin resistance, and accumulate cardiometabolic risk just as much as patients on full antipsychotic doses. Z-drugs, low-dose doxepin, melatonin agonists, and CBT-I are usually safer for primary insomnia.

Why is Qutan SR 400 effective in bipolar depression?

The norquetiapine metabolite inhibits the noradrenaline transporter — adding an antidepressant component to the sedating-stabilising profile of the parent drug. Quetiapine and lurasidone are the two main atypicals with FDA approval for bipolar depression; quetiapine is more sedating, lurasidone is metabolically cleaner.

Will Qutan SR 400 make me gain weight?

Yes — typically 3–7 kg over 6 months, sometimes more. Dose-related but real at all doses. Plot weight at every visit and counsel about diet/exercise from week 1.

How long until Qutan SR 400 works?

Sleep effect: same night. Mood/anxiety effect: 1–2 weeks. Antipsychotic effect: 2–6 weeks at adequate dose. Bipolar depression effect: 2–6 weeks.

What is the difference between IR and SR quetiapine?

Both have the same molecule and the same active metabolite. SR/XR delivers it more slowly, producing a flatter sedation peak — better for daytime function and easier once-daily dosing. IR has stronger immediate sedation, useful when bedtime sedation is desired.

Can Qutan SR 400 be stopped abruptly?

Taper over 2–4 weeks. Abrupt cessation can produce cholinergic rebound (nausea, sweating, insomnia) and antipsychotic relapse. Never stop without prescriber agreement.

What about driving on Qutan SR 400?

Avoid driving for at least the first 1–2 weeks of any new dose. Many patients on stable bedtime doses drive normally during the day; some patients on higher daytime doses or split BID dosing remain too sedated to drive safely.

Can Qutan SR 400 be combined with an SSRI?

Yes — quetiapine SR is FDA-approved as an adjunct to SSRI/SNRI in MDD at low doses (50–300 mg HS). Sometimes used in treatment-resistant anxiety as well.

Why avoid grapefruit juice?

Grapefruit juice strongly inhibits intestinal CYP3A4. Quetiapine is a CYP3A4 substrate; grapefruit raises levels markedly, increasing sedation, orthostasis, and metabolic burden. Avoid grapefruit and grapefruit juice during Qutan SR 400 therapy.

Other Mental Health Medications

Medical disclaimer. This page is educational and is not a substitute for individualised medical advice. Mental-health pharmacotherapy should be initiated, monitored, and adjusted under a qualified clinician. If you or someone you know is in suicidal crisis, contact local emergency services immediately, or call your country’s suicide-prevention helpline (US/Canada: 988; UK: Samaritans 116 123; international list: findahelpline.com).

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