TIANEPTINE — 12.5 mg tablets (also 37.5 mg ER)

Atypical antidepressant • MOR agonist • MDD • anxiety • Rx-only

Prescription-only medicine. Educational content: strengths, brand examples, safety notes, FAQ, and official references. Always follow your local leaflet and clinician guidance.

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📦 Snapshot
🧠 Overview
🏷️ Brands
⚠️ Safety
❓ FAQ
📚 References

📦 Product Snapshot

Active substanceTianeptine sodium

Strengths12.5 mg (immediate‑release) · 37.5 mg (extended‑release)

Dosage formFilm‑coated tablets · ER tablets

12.5 mg is the standard dose, taken three times daily. ER version (37.5 mg) allows once‑daily dosing.

Reference brandsStablon® · Coaxil® · Tatinol® (Servier)

India brand examplesStablon® (Servier) · Tynept® (Intas) · Eason® · Anept® · Tiazac® · Wellsteb® · Stabnodep® · Syneptine® · Tip® · Tiaptin®

Primary indicationsMajor depressive disorder (MDD) · Anxiety disorders (off‑label in some countries) · Irritable bowel syndrome (off‑label)

Approved in Europe, Asia, South America. Not FDA‑approved in the USA.

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🧠 Overview

Tianeptine is an atypical antidepressant with a unique mechanism of action that differs radically from SSRIs. Initially, it was thought to enhance serotonin reuptake (opposite to all other antidepressants), but modern research has revealed its primary action as a full agonist at mu-opioid receptors (MOR) in the brain. Activation of MOR on GABAergic interneurons in the hippocampus is responsible for its rapid antidepressant effects.

Clinical advantages: Tianeptine has proven efficacy equivalent to classical tricyclics (amitriptyline, clomipramine) and SSRIs (fluoxetine, paroxetine, sertraline). It stands out for its favorable tolerability profile: it does not cause sexual dysfunction, weight gain, sedation, cardiotoxicity, or anticholinergic effects (dry mouth, constipation). A key advantage is its rapid onset of action — improvement can be observed within 7 days, whereas SSRIs typically require 3-6 weeks.

Regulatory and safety context: Tianeptine is approved in Europe, Asia, and South America, but not in the USA due to concerns related to its opioid mechanism and abuse potential. With oral administration at therapeutic doses, the risk of dependence is low. However, cases of intravenous misuse (especially in former Soviet countries) to achieve euphoria have been documented, leading to severe complications including thrombosis and tissue necrosis due to insoluble tablet fillers. The drug requires gradual withdrawal over 7-14 days to avoid discontinuation syndrome.

🏷️ Strengths & Brand Examples

Available strengths

12.5 mg immediate‑release tablets (standard dose, three times daily)
37.5 mg extended‑release tablets (once-daily dosing, developed by Intas)

India brands (examples)

Stablon® 12.5 mg (Servier India Private Ltd) — original brand
Tynept® 12.5 mg (Intas Pharmaceuticals Ltd) — also available as ER 37.5 mg
Eason® 12.5 mg (Alde Medi Impex Ltd)
Anept® 12.5 mg (Consern Pharma Limited)
Tiazac® 12.5 mg (Ryon Pharma)
Wellsteb® 12.5 mg (Tripada Healthcare Pvt Ltd)
Stabnodep® 12.5 mg (Lifecare Neuro Products Ltd)
Syneptine® 12.5 mg (Synokem Pharmaceuticals Ltd)
Tip® 12.5 mg (Chemo Healthcare Pvt Ltd)
Tiaptin® 12.5 mg (Kriven Health Solutions)

International reference brands

Stablon® (Servier — Europe, Asia, Australia)
Coaxil® (Servier — some markets)
Tatinol® (Servier — some markets)
Tianeurax® (neuraxpharm — Germany)

Note: brand availability changes. Verify manufacturer and on‑pack labeling for current listings. Always obtain with valid prescription.

⚠️ Safety, Side Effects & Monitoring

Commonly discussed effects

Headache, dizziness
Dry mouth, constipation, nausea, abdominal pain (usually mild)
Somnolence, insomnia, vivid dreams
Tachycardia, extrasystoles (rare)
Myalgia, back pain
Lump in throat sensation, dyspnea (rare)

Sexual dysfunction, weight gain, and sedation occur significantly less often than with SSRIs and TCAs.

Serious risks & label-first warnings

• Abuse potential (MOR agonist): Tianeptine activates mu-opioid receptors. Oral therapeutic doses carry low risk, but intravenous misuse for euphoria has been reported. Tablets contain insoluble excipients (silica) which, when injected, cause capillary thrombosis and severe tissue necrosis.
• Withdrawal syndrome: Abrupt discontinuation can cause insomnia, anxiety, irritability, nausea, diarrhea, confusion. Taper over 7-14 days.
• MAOI interaction: Contraindicated with non-selective MAOIs (risk of hypertensive crisis, hyperthermia, seizures, death). Allow 2-week washout after MAOI discontinuation. When switching from tianeptine to MAOI, 24 hours is sufficient.
• Children under 15: Contraindicated (safety not established).
• Pregnancy and lactation: Avoid (crosses placenta, excreted in milk).
• Suicidal risk: Like all antidepressants, monitor for worsening depression or suicidal thoughts, especially in young adults during initial treatment.
• Bipolar switching: May precipitate manic episodes in patients with unrecognized bipolar disorder. Discontinue if signs of mania appear.
• Driving: May cause dizziness or somnolence — caution when operating machinery.

⚠️ DEPENDENCE AND WITHDRAWAL — CRITICAL INFORMATION

Physical dependence: Therapeutic use for several weeks can lead to physical dependence. Do not stop abruptly.

Withdrawal symptoms: Insomnia, anxiety, irritability, agitation, nausea, abdominal pain, diarrhea, confusion, sweating. Usually mild-moderate but can be distressing.

Recommended taper: Gradually reduce dose over 7-14 days under medical supervision. Extended-release formulation (37.5 mg once daily) may facilitate tapering in some patients.

Misuse warning: Never crush tablets for injection. Insoluble fillers cause irreversible capillary damage, gangrene, and severe infections.

Drug interactions

Contraindicated: Non-selective MAOIs (phenelzine, tranylcypromine, isocarboxazid, iproniazid, nialamide) — risk of severe serotonin syndrome-like reaction.
Caution with: Other CNS depressants (alcohol, benzodiazepines, opioids) — additive sedation.
Alcohol: Avoid — increases dizziness, sedation, and impairs judgment.

❓ FAQ

FAQ question #1: Is tianeptine an opioid? Does it cause euphoria?

Answer: Tianeptine is a mu-opioid receptor (MOR) agonist, so it acts on the same receptors as classical opioids. However, at oral therapeutic doses (12.5 mg three times daily), it does not produce euphoria or respiratory depression typical of opioids. Its antidepressant effect is mediated by MOR activation, but its unique pharmacokinetics limit abuse potential when taken orally. Euphoria is only reported with high doses or intravenous use, which is extremely dangerous due to tablet excipients.

FAQ question #2: How quickly does tianeptine work for depression?

Answer: Tianeptine has a rapid onset of action — improvement in depressive symptoms can be observed within 7 days, and full response often by 2-4 weeks. This is significantly faster than SSRIs, which typically require 4-6 weeks. The rapid effect is attributed to its direct MOR-mediated neuroplasticity changes in the hippocampus.

FAQ question #3: Does tianeptine cause sexual dysfunction or weight gain?

Answer: No, tianeptine is virtually free of sexual side effects and weight gain — major advantages over SSRIs. Studies show no significant difference from placebo in rates of sexual dysfunction, and weight remains stable during treatment. This makes it particularly suitable for patients who experienced these issues with other antidepressants.

FAQ question #4: What is the difference between 12.5 mg IR and 37.5 mg ER?

Answer: The standard immediate-release (IR) formulation (12.5 mg) must be taken three times daily due to its short half-life. The extended-release (ER) formulation (37.5 mg, developed by Intas in India) is taken once daily, improving convenience and adherence. ER provides smoother blood levels and may have lower abuse potential. Both are prescription-only.

FAQ question #5: Why is tianeptine not available in the USA?

Answer: Tianeptine was never approved by the FDA. In recent years, the FDA has issued warnings about unapproved tianeptine products sold as dietary supplements, which have been linked to severe adverse events including death. The FDA classifies it as a “new dietary ingredient” for which no adequate safety data exists. Additionally, its mu-opioid agonist activity raised regulatory concerns. It remains a prescription drug in many other countries with appropriate monitoring.