⚡ Quick Answer — What is Opiprol?
Opiprol bevat opipramol 50 mg from a WHO-GMP certified manufacturer (Sun Pharma) — an atypical TCA-related anxiolytic with primary use in generalised anxiety disorder (GAD) and somatoform disorders. Distinct from classic TCAs: opipramol does niet inhibit monoamine reuptake. Its mechanism is dominated by sigma-1 and sigma-2 receptor agonism plus H1 antihistamine and weak D2 antagonism. Standard dose: 50–150 mg/day in 1–3 divided doses. Onset: 1–3 weeks. Marketed primarily in Germany, Switzerland, Austria, and parts of Eastern Europe as Insidon. Not FDA-approved — not available in the US or UK as a licensed product. Lower anticholinergic burden than classic TCAs.
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What Is Opiprol?
Opiprol is an oral tablet of opipramol dihydrochloride 50 mg manufactured by Sun Pharma. Opipramol is a tricyclic compound structurally related to imipramine but pharmacologically very different — it does not significantly inhibit serotonin or norepinephrine reuptake. Instead it is a high-affinity sigma-1 and sigma-2 receptor agonist with secondary H1-antihistamine and weak D2-antagonist action. It has been used clinically since 1961 (introduced as Insidon by Geigy) and remains a standard outpatient anxiolytic in the German-speaking world.
Goedgekeurde indicaties
- Generalised anxiety disorder (GAD) — the primary clinical use
- Somatoform disorders — somatisation, persistent functional somatic symptoms
- Adjunctive treatment in mild-to-moderate depression with prominent anxiety
- Insomnia secondary to anxiety
Dosering
| Indicatie | Start | Typical | Maximum | Opmerkingen |
|---|---|---|---|---|
| GAD, somatoform | 50 mg evening × 3–5 days | 50–150 mg/day in 1–3 doses | 300 mg/day | Most prescribers use 50–100 mg evenings or 50 mg + 100 mg morning + evening |
| Anxiety with insomnia | 50 mg at bedtime | 50–100 mg at bedtime | 150 mg at bedtime | Sedation peaks 2–3 h after dose |
| Elderly | 25–50 mg evening | 50–100 mg/day | 150 mg/day | Lower target; more sensitive to sedation and orthostasis |
Bijwerkingen
Side-effect profile
| Frequentie | Effect | Opmerkingen |
|---|---|---|
| Vaak voorkomend | Sedation, fatigue | Useful at bedtime; can be limiting if dosed during the day |
| Vaak voorkomend | Droge mond | Mild anticholinergic burden — less than imipramine or amitriptyline |
| Vaak voorkomend | Weight gain (modest) | H1 appetite stimulation |
| Vaak voorkomend | Dizziness, mild orthostatic hypotension | Caution standing quickly, particularly in elderly |
| Less common | Constipation, blurred vision | Anticholinergic |
| Zeldzaam | QT-verlenging | Caution with other QT-prolonging drugs |
| Zeldzaam | Hyponatraemia, transient liver enzyme elevation | Monitor in long-term use |
Geneesmiddelinteracties
Avoid combination with MAOIs — 14-day washout though serotonin syndrome risk is low given absent SERT activity.
Additive CNS depression: alcohol, benzodiazepines, opioids, antihistamines — combine cautiously.
QT-verlenging: caution with citalopram (high dose), fluoroquinolones, quetiapine, ondansetron.
Anticholinergic burden: additive with diphenhydramine, oxybutynin, trihexyphenidyl.
Veelgestelde vragen
How long does Opiprol take to work?
Some patients notice improvement in anxiety and sleep within 1–2 weeks; full GAD response typically appears at 4–6 weeks of consistent dosing.
Is Opiprol a true antidepressant?
It is structurally a tricyclic but pharmacologically more an anxiolytic. Its primary licensed use across Europe is GAD and somatoform disorders, not classic depression. SSRIs and SNRIs are first-line where MDD is the dominant problem.
Why is Opiprol not used in the US or UK?
Opipramol was developed in Switzerland in 1961 and never pursued by manufacturers for FDA / MHRA approval. It remains a standard prescription drug in Germany, Switzerland, Austria, Poland, Turkey, and other European markets.
Is Opiprol safer than benzodiazepines for chronic anxiety?
Yes — opipramol has no dependence potential, no abuse risk, and no rebound anxiety on stopping. It is a sensible alternative when benzodiazepines would be problematic for chronic GAD.
Will Opiprol cause dependence or withdrawal?
No physiological dependence is recognised. Mild rebound insomnia or anxiety can occur if a long-term dose is stopped abruptly — tapering over 1–2 weeks is sensible.
Can I drink alcohol on Opiprol?
Avoid heavy alcohol — additive sedation. Light occasional alcohol is generally tolerated.
Is Opiprol safe in pregnancy?
Limited safety data — not preferred in pregnancy. Discuss alternatives with the prescriber.
Wat gebeurt er als ik een dosis mis?
Take it as soon as you remember unless close to the next dose. Missing a single dose rarely causes problems given the long half-life.
Will Opiprol cause sexual side effects?
Less than SSRIs — opipramol is often used as a switch destination when SSRI-induced sexual dysfunction is intolerable in patients whose primary problem is anxiety rather than depression.
How should Opiprol be stored?
Store at 15–30 °C in the original blister packaging, away from moisture and sunlight. Keep out of reach of children.
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