Generic Remeron ( Mirtazapine )

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Remeron (mirtazapine) is an atypical tetracyclic antidepressant (TeCA) that is used to treat major depressive disorder and is particularly beneficial when symptoms of insomnia or poor appetite are prominent. It works by blocking presynaptic alpha‑2 adrenergic receptors, which increases the release of both norepinephrine and serotonin, while also blocking specific postsynaptic serotonin receptors (5‑HT₂ and 5‑HT₃) that can cause side effects when stimulated. This dual action helps improve mood, sleep, and appetite, often with a lower incidence of sexual dysfunction and gastrointestinal upset than with SSRIs.

Usual adult dose: The recommended starting dose is 15 mg taken once daily, preferably in the evening before bedtime. If the response is inadequate, the dose may be increased every 1 to 2 weeks, up to a maximum of 45 mg per day. The effective dose range is generally 15 mg to 45 mg daily. Because mirtazapine is more sedating at lower doses (7.5 mg to 15 mg), a 7.5 mg starting dose may be used for patients who are elderly, frail, or highly sensitive to side effects, with upward titration as tolerated.

Dosage form: Orally disintegrating tablets (Remeron RD/SolTab) and film‑coated tablets in strengths of 7.5 mg, 15 mg, and 30 mg.

Onset of action: Some improvement in sleep and appetite may occur within the first week of therapy. Antidepressant effects typically begin within 1 to 2 weeks, with full clinical response taking 4 to 6 weeks.

Duration of action: The elimination half‑life of mirtazapine is 20 to 40 hours, supporting once‑daily dosing. Steady‑state plasma concentrations are achieved after approximately 3 to 5 days of regular administration.

Alcohol recommendation: Alcohol consumption should be avoided during treatment with Remeron. Alcohol can worsen depression and anxiety symptoms, potentiate the sedative effects of the medication, and increase the risk of dizziness, impaired coordination, and excessive drowsiness.

Most common side effects: Somnolence (drowsiness, up to 54%), increased appetite (17%), weight gain (12%), dry mouth (25%), dizziness (7%), and constipation. These side effects are often most pronounced at the start of therapy and may diminish over time; however, increased appetite and weight gain tend to persist.

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General Information about Remeron (Mirtazapine)

• INN (International Nonproprietary Name): Mirtazapine
• Brand names available in Canada: Remeron® and Remeron RD® (Orally Disintegrating Tablets/SolTab) by Organon Canada Inc. Generic versions available in Canada include APO‑Mirtazapine (Apotex Inc.), TEVA‑Mirtazapine (Teva Canada Limited), PMS‑Mirtazapine (Pharmascience Inc.), Sandoz Mirtazapine (Sandoz Canada Inc.), AURO‑Mirtazapine (Auro Pharma Inc.), JAMP‑Mirtazapine (JAMP Pharma Corporation), M‑Mirtazapine (Mantra Pharma Inc.), and others.
• ATC code: N06AX11
• Dosage forms and strengths: Orally disintegrating tablets (RD/SolTab): 7.5 mg, 15 mg, and 30 mg. Film‑coated tablets: 7.5 mg, 15 mg, and 30 mg. A 45 mg tablet is also available. The orally disintegrating tablets dissolve rapidly on the tongue and do not require water.
• Manufacturers in Canada: Organon Canada Inc. (Remeron, Remeron RD), Apotex Inc., Teva Canada Limited, Pharmascience Inc., Sandoz Canada Inc., Auro Pharma Inc., JAMP Pharma Corporation, Mantra Pharma Inc., and other generic manufacturers.
• Registration status in Canada: Approved by Health Canada. Marketed (DINs: Remeron RD 15 mg – 02248542; generic mirtazapine tablets – various DINs).
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act.

Mechanism of Action and Pharmacology

Mirtazapine is a tetracyclic antidepressant with a mechanism of action distinct from SSRIs and SNRIs. It acts as an antagonist at central presynaptic alpha‑2 adrenergic receptors on both norepinephrine and serotonin neurons. By blocking these auto‑ and heteroreceptors, mirtazapine removes the normal inhibitory feedback mechanism, leading to a net increase in the release of both norepinephrine and serotonin. The increased serotonin is then directed preferentially toward 5‑HT₁ receptors because mirtazapine simultaneously blocks postsynaptic 5‑HT₂ and 5‑HT₃ receptors. This selective enhancement of 5‑HT₁‑mediated neurotransmission is believed to contribute to its antidepressant, anxiolytic, and anti‑insomnia effects while minimising the sexual dysfunction, nausea, and agitation often associated with SSRIs and SNRIs. Mirtazapine is also a potent antagonist of histamine H₁ receptors, which accounts for its prominent sedative and appetite‑stimulating effects, particularly at lower doses (7.5 mg to 15 mg). At higher doses (30 mg to 45 mg), the noradrenergic effects become more pronounced, which can partially offset the sedation caused by H₁ blockade. The drug has minimal affinity for muscarinic cholinergic receptors, contributing to a lower incidence of anticholinergic side effects (e.g., constipation, urinary retention, blurred vision) compared with tricyclic antidepressants.

Following oral administration, mirtazapine is rapidly and completely absorbed, with peak plasma concentrations reached within approximately 2 hours. The absolute bioavailability is approximately 50% due to first‑pass metabolism. Food does not significantly affect absorption. Mirtazapine is extensively metabolised in the liver, primarily by cytochrome P450 isoenzymes CYP2D6, CYP1A2, and CYP3A4. The main metabolites are demethylmirtazapine and mirtazapine‑N‑oxide, both of which are pharmacologically active but at much lower potency than the parent compound. The elimination half‑life is 20 to 40 hours, and steady‑state plasma levels are reached in 3 to 5 days. Approximately 75% of a dose is excreted in the urine and 15% in the faeces. Mirtazapine is approximately 85% bound to plasma proteins.

Mirtazapine exhibits linear pharmacokinetics over the therapeutic dose range. The orally disintegrating tablet (Remeron RD/SolTab) is bioequivalent to the conventional film‑coated tablet.

Indications

• Major Depressive Disorder (MDD): For the treatment of moderate to severe major depressive disorder in adults.
• Off‑label uses: Mirtazapine is frequently prescribed off‑label for generalised anxiety disorder (GAD), panic disorder, post‑traumatic stress disorder (PTSD), obsessive‑compulsive disorder (OCD), social anxiety disorder, and insomnia. It is also used for the management of cachexia (wasting) and poor appetite in chronically ill patients, for antipsychotic‑induced akathisia, and for migraine prophylaxis. Clinicians often select mirtazapine for patients with depression accompanied by significant insomnia, weight loss, or anxiety.
• Not indicated for use in paediatric patients; safety and efficacy have not been established in children and adolescents under 18 years of age.

Important Warnings and Precautions

At‑risk groups

• Pregnancy: There are limited data on the use of mirtazapine in pregnant women. Animal studies have not demonstrated teratogenic effects, but have shown foetal growth restriction at high doses. Mirtazapine should be used during pregnancy only if the potential benefit clearly outweighs the potential risk. Infants exposed to antidepressants late in the third trimester may develop postnatal withdrawal symptoms and require supportive care.
• Breastfeeding: Mirtazapine is excreted in human breast milk in small amounts. The decision to breastfeed while taking mirtazapine should be made in consultation with a physician, considering the importance of the drug to the mother and the potential risk to the infant.
• Paediatrics (< 18 years): Safety and efficacy have not been established in children and adolescents. Health Canada has issued warnings regarding the use of antidepressants in paediatric patients, citing an increased risk of suicidal ideation and behaviour.
• Elderly: Elderly patients may be more sensitive to the sedative and hypotensive effects of mirtazapine. A lower starting dose (7.5 mg) is recommended, with gradual titration. Renal function should be assessed, as clearance may be reduced in older adults.
• Hepatic impairment: Mirtazapine is extensively metabolised by the liver. In patients with hepatic impairment, clearance is reduced by approximately 30%. A lower starting dose and slower titration are recommended, and liver function should be monitored.
• Renal impairment: In patients with moderate to severe renal impairment (creatinine clearance < 40 mL/min), the clearance of mirtazapine is reduced by approximately 30% to 50%. A lower starting dose and careful upward titration are advised.
• Bipolar disorder: Screen for bipolar disorder before initiating treatment. Mirtazapine may precipitate a manic or hypomanic episode in patients with undiagnosed bipolar disorder.
• Seizure disorders: Mirtazapine may lower the seizure threshold. Use with caution in patients with epilepsy or a history of seizures.
• Cardiovascular disease: Mirtazapine may cause orthostatic hypotension, particularly in the elderly and in patients with pre‑existing cardiovascular disease or dehydration. Use with caution in patients with a history of myocardial infarction, angina, or hypotension.
• Angle‑closure glaucoma: Mirtazapine may cause pupillary dilatation, which can trigger an acute attack of angle‑closure glaucoma. Patients at risk should have an ophthalmologic evaluation before starting therapy.
• Agranulocytosis: Rare cases of agranulocytosis (severe neutropenia) have been reported, occurring in approximately 0.1% of patients. Patients should be advised to report any signs of infection (fever, sore throat, mouth ulcers) promptly, and a complete blood count should be obtained if these symptoms occur. Mirtazapine should be discontinued if neutropenia is confirmed.
• Serotonin syndrome: A potentially life‑threatening serotonin syndrome may occur with mirtazapine, particularly when used in combination with other serotonergic drugs. Symptoms include mental status changes (agitation, confusion, coma), autonomic instability (hyperthermia, tachycardia, labile blood pressure), neuromuscular abnormalities (hyperreflexia, myoclonus, rigidity), and gastrointestinal symptoms (nausea, vomiting, diarrhoea). Immediate medical attention is required.
• Allergy: Do not take Remeron if you have a known hypersensitivity to mirtazapine or any excipient in the formulation.

Driving and alcohol

Remeron causes significant sedation and drowsiness in many patients, particularly during the first few weeks of therapy and after dose increases. It can impair the mental alertness and physical coordination required for driving and operating heavy machinery. Patients should not drive or engage in hazardous activities until they have determined how the medication affects them. Alcohol must be avoided during treatment, as it can potentiate the sedative effects of mirtazapine and may worsen depression and anxiety.

Dosage Instructions

• Major Depressive Disorder: The recommended starting dose is 15 mg once daily, preferably in the evening before bedtime. The dose may be increased after 1 to 2 weeks, in 15 mg increments, to a maximum of 45 mg daily. Common maintenance doses are 15 mg, 30 mg, or 45 mg once daily.
• Low‑dose regimen for sensitive patients: For elderly, frail, or highly sensitive patients, a starting dose of 7.5 mg once daily at bedtime may be used, with upward titration to 15 mg, 30 mg, or 45 mg as tolerated and clinically indicated.
• Administration: Remeron is best taken as a single dose at bedtime to minimise daytime sedation and to help improve sleep. The orally disintegrating tablet (Remeron RD/SolTab) should be placed on the tongue and allowed to dissolve; it does not require water. Patients should not attempt to push the tablet through the foil backing; instead, the foil should be peeled back. The tablet should be used immediately after opening the blister.
• Switching to or from an MAOI: At least 14 days must elapse between discontinuing an MAOI and starting Remeron, and vice versa.
• Dose adjustment with CYP3A4 inducers/inhibitors: An increase in dose may be necessary with strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin). Conversely, a decrease in dose may be required with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) or cimetidine.
• Missed dose: If a dose is missed at bedtime, it should be skipped entirely and the regular schedule resumed the following evening. Do not double the dose to make up for a missed one. Do not take Remeron in the morning or during the day unless specifically instructed by a physician, as this can cause significant daytime drowsiness.
• Discontinuation: Gradual tapering is recommended over several weeks rather than abrupt cessation, to minimise the risk of withdrawal symptoms (dizziness, nausea, headache, anxiety, sleep disturbances).

Side Effects and Contraindications

• Very common side effects (≥ 10%): Somnolence (drowsiness, up to 54%), dry mouth (up to 25%), increased appetite (up to 17%), and weight gain (up to 12%).
• Common side effects (1‑10%): Dizziness (7%), constipation, peripheral oedema (fluid retention), increased liver enzymes (ALT/AST), and abnormal dreams.
• Less common but serious side effects: Agranulocytosis (severe neutropenia, incidence ~0.1%), serotonin syndrome, orthostatic hypotension, mania or hypomania, seizures, akathisia (psychomotor restlessness), hyponatraemia (especially in the elderly), and QT prolongation (rare, but requires ECG monitoring in patients with risk factors).
• Paradoxically lower sedation at higher doses: Interestingly, sedation is often more pronounced at lower doses (7.5 mg to 15 mg) because of the predominance of histamine H₁ receptor blockade. At higher doses (30 mg to 45 mg), the increasing noradrenergic activity can partially offset the sedative effect.
• Contraindications: Hypersensitivity to mirtazapine or any excipient in the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy. Concomitant use with linezolid or intravenous methylene blue (risk of serotonin syndrome).

Drug Interactions

• Major interactions (contraindicated): Monoamine oxidase inhibitors (MAOIs), including linezolid and intravenous methylene blue—risk of serotonin syndrome; allow at least a 14‑day washout period.
• Serotonergic drugs (monitor closely): Other antidepressants (SSRIs, SNRIs, TCAs), triptans, fentanyl, lithium, tramadol, buspirone, St. John’s wort, tryptophan, and other drugs that affect serotonin may increase the risk of serotonin syndrome when used together with mirtazapine.
• CNS depressants: Alcohol, benzodiazepines, opioids, sedating antihistamines, and other central nervous system depressants will increase the sedative and psychomotor‑impairing effects of mirtazapine. These combinations should be used with caution, and patients should be advised against driving or operating machinery.
• Strong CYP3A4 inducers: Carbamazepine, phenytoin, rifampin, and other strong CYP3A4 inducers can decrease mirtazapine plasma levels. An increase in the mirtazapine dose may be required.
• Strong CYP3A4 inhibitors: Ketoconazole, clarithromycin, ritonavir, and other strong CYP3A4 inhibitors can increase mirtazapine plasma levels. A decrease in the mirtazapine dose may be needed.
• Cimetidine: May increase mirtazapine bioavailability; dose reduction of mirtazapine may be considered.
• Warfarin: Mirtazapine does not appear to have a clinically significant interaction with warfarin, but INR monitoring is recommended as a general precaution.
• Alcohol: Alcohol should be avoided, as it potentiates sedation and may worsen depression.

Practical Advice

• Administration: Take Remeron once daily at bedtime. Swallow the film‑coated tablet whole with water; do not crush or chew. If using the orally disintegrating tablet (Remeron RD/SolTab), peel back the foil, place the tablet on the tongue, and allow it to dissolve; do not chew or swallow it whole. Use immediately after opening the blister. Do not take the medication during the day as this will cause significant drowsiness.
• Monitoring: No routine laboratory monitoring is required for most patients. However, a complete blood count should be obtained if signs or symptoms of agranulocytosis develop (fever, sore throat, mouth ulcers, or other signs of infection). Weight and body mass index should be monitored periodically because mirtazapine commonly causes weight gain. Liver function tests may be considered in patients with pre‑existing hepatic impairment or in those who develop symptoms of liver dysfunction (jaundice, dark urine, upper abdominal pain).
• Storage: Store at room temperature (15‑30 °C) in a dry place, protected from moisture and light. Keep the tablets in their original packaging, and keep the blister pack sealed until use. Keep out of the reach and sight of children.
• Lifestyle: Remeron is best combined with healthy lifestyle habits: a balanced, calorie‑conscious diet to manage the increased appetite and tendency toward weight gain; regular physical activity; good sleep hygiene; and avoidance of alcohol and recreational drugs. Do not stop the medication abruptly; if discontinuation is needed, contact your healthcare provider for a gradual tapering schedule to minimise withdrawal symptoms.
• Missed dose: If you miss a dose at bedtime, skip it entirely and take the next dose at the usual time the following evening. Never take a double dose to make up for a missed one, and do not take the medication during the daytime.
• When to seek medical review: Contact your doctor promptly if you develop signs of infection (fever, sore throat, mouth ulcers), jaundice, a new rash, severe dizziness, fainting, rapid heart rate, or any other concerning symptoms. Seek emergency medical attention for signs of a serious allergic reaction (swelling of the face, lips, tongue, or throat; difficulty breathing), serotonin syndrome (agitation, confusion, fever, muscle rigidity, seizures), or if you experience suicidal thoughts or self‑harm urges.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Selective serotonin reuptake inhibitors (SSRIs): Sertraline (Zoloft), escitalopram (Cipralex), fluoxetine (Prozac), paroxetine (Paxil), and citalopram (Celexa) are first‑line antidepressants for major depressive disorder. They have a more activating profile and are less likely to cause weight gain or sedation, but they carry a higher risk of sexual dysfunction and gastrointestinal side effects.
• Serotonin‑norepinephrine reuptake inhibitors (SNRIs): Venlafaxine (Effexor), duloxetine (Cymbalta), and desvenlafaxine (Pristiq) are first‑line antidepressants that, like mirtazapine, increase both serotonin and norepinephrine. They are more activating than mirtazapine and may be preferred when sedation is undesirable.
• Other atypical antidepressants: Bupropion (Wellbutrin) is an activating, non‑sedating antidepressant that does not cause weight gain or sexual dysfunction. Vortioxetine (Trintellix) is a multimodal antidepressant with a unique receptor profile and lower sedation.
• Tricyclic antidepressants (TCAs): Amitriptyline (Elavil), clomipramine (Anafranil), and nortriptyline (Aventyl) are older antidepressants that are effective but carry a higher burden of anticholinergic side effects, cardiac toxicity in overdose, and sedation. They are generally reserved for treatment‑resistant cases.
• Monoamine oxidase inhibitors (MAOIs): Phenelzine (Nardil) and tranylcypromine (Parnate) are effective but require dietary tyramine restriction and have significant drug interaction risks. They are third‑line agents.
• Non‑pharmacological approaches: Cognitive behavioural therapy (CBT), interpersonal therapy (IPT), and behavioural activation are first‑line, evidence‑based psychotherapies for depression. Exercise, sleep hygiene, and stress reduction techniques are important adjunctive measures.

Clinical Efficacy

Mirtazapine has been demonstrated in randomised controlled trials to be an effective treatment for major depressive disorder. In a pooled analysis of placebo‑controlled studies, mirtazapine produced a significantly greater reduction in Hamilton Depression Rating Scale (HAM‑D) scores than placebo, with a response rate of approximately 50‑60% at doses of 15 mg to 45 mg/day. In head‑to‑head comparisons, mirtazapine has shown similar overall antidepressant efficacy to SSRIs such as fluoxetine and sertraline. A notable finding from meta‑analyses is that mirtazapine may have an earlier onset of action than SSRIs: a statistically significant separation from placebo has been observed as early as week 1 of therapy, compared with the typical 2‑4 weeks for SSRIs.

The unique side‑effect profile of mirtazapine has been demonstrated consistently across trials. Sedation is reported in up to 54% of patients, increased appetite in 17%, and weight gain in 12%. The weight gain associated with mirtazapine is substantial—an average of 1.5 kg to 3 kg over 6‑12 months—and appears to be mediated by both H₁ receptor blockade (increasing appetite) and 5‑HT_2C antagonism. While this is often undesirable in overweight patients, it can be advantageous in patients with depression‑associated weight loss or in cachectic, chronically ill individuals. Mirtazapine consistently causes less sexual dysfunction than SSRIs, a significant advantage for patient adherence.

In a 2024 randomised, double‑blind, placebo‑controlled trial in older adults with chronic insomnia (the MIRAGE study), low‑dose mirtazapine (7.5 mg to 15 mg at bedtime) significantly reduced insomnia severity at 4 weeks as measured by the Insomnia Severity Index, supporting its use for the insomnia that commonly accompanies depression. The DREAMING study (2025) found that low‑dose mirtazapine provided a clinically and statistically significant reduction in insomnia severity at 6 weeks compared with placebo in patients with insomnia disorder and sleep maintenance problems.

The Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 guidelines list mirtazapine as a first‑line or second‑line antidepressant, particularly for patients with depression accompanied by significant insomnia, anxiety, or poor appetite. SSRIs and SNRIs remain the recommended first‑line agents, but mirtazapine is an important option for patients who do not tolerate or respond adequately to these medications.

Important:

Remeron (mirtazapine) is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It may increase the risk of suicidal thoughts and behaviour, particularly in children, adolescents, and young adults under 24 years of age. Close monitoring by family, friends, and healthcare providers is essential during the first weeks of treatment and after dosage changes. This medication causes significant sedation; do not drive or operate heavy machinery until you know how it affects you. Do not discontinue the medication abruptly, as this may cause withdrawal symptoms. A rare but serious risk of agranulocytosis (severely low white blood cell count) exists; seek medical attention immediately if you develop signs of infection such as fever, sore throat, or mouth ulcers. If you experience symptoms of serotonin syndrome (agitation, confusion, fever, muscle rigidity, rapid heart rate), a manic episode (extreme elation, racing thoughts, risk‑taking behaviour), or a severe allergic reaction, stop taking the medication and seek emergency medical attention. Alcohol should be avoided during treatment. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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