⚡ Quick Answer — What is Trazonil?
Trazonil bevat trazodone hydrochloride (50 mg / 100 mg) from a WHO-GMP certified manufacturer (Intas Pharmaceuticals) — a SARI antidepressant whose primary modern use is insomnia at low dose (25–100 mg at bedtime) rather than depression. Mechanism: 5-HT2A antagonism plus weak SRI plus alpha-1 antagonism plus H1 antagonism — the 5-HT2A/H1/alpha-1 combination drives sedation. Antidepressant doses (150–400 mg/day) are uncommon today — SSRIs and SNRIs largely replaced trazodone for MDD. Off-label insomnia is its dominant use. Important warnings: priapism (rare, 1 in 1,000–10,000 — emergency if > 4 h), orthostatic hypotension (alpha-1), QT prolongation at high doses. Very safe in overdose compared to TCAs.
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What Is Trazonil?
Trazonil is an oral tablet of trazodone hydrochloride (50 mg / 100 mg) manufactured by Intas Pharmaceuticals. Trazodone (US brand Desyrel) is a serotonin antagonist and reuptake inhibitor (SARI) introduced in 1981. It blocks 5-HT2A receptors potently, weakly inhibits the serotonin transporter, and antagonises alpha-1 adrenergic and H1 histamine receptors. The combination is heavily sedating — which is why trazodone has become predominantly an off-label hypnotic rather than an antidepressant in modern practice.
Indicaties
- Major depressive disorder — on-label, but uncommon today (SSRIs / SNRIs are first-line)
- Insomnia (off-label, low-dose) — the most common modern use; 25–100 mg at bedtime
- Off-label adjuncts: SSRI-induced insomnia, anxiety with insomnia, agitation in dementia (used with caution)
Dosering
| Indicatie | Start | Typical | Maximum | Opmerkingen |
|---|---|---|---|---|
| Insomnia (off-label) | 25–50 mg at bedtime | 50–100 mg at bedtime | 150 mg at bedtime | Most commonly used dose range; effective hypnotic without significant antidepressant action |
| MDD (on-label) | 50–75 mg/day in divided doses | 150–400 mg/day | 600 mg/day inpatient | Daytime divided doses for antidepressant effect; sedation often prohibitive |
| Elderly insomnia | 25 mg at bedtime | 25–50 mg at bedtime | 100 mg | Caution — orthostasis and falls |
| Leverfunctiestoornis | Reduce by 25–50% | — | — | Slower titration |
Bijwerkingen
Side-effect profile
| Frequentie | Effect | Opmerkingen |
|---|---|---|
| Vaak voorkomend | Sedation, drowsiness | The point of off-label hypnotic use; problematic for daytime dosing |
| Vaak voorkomend | Orthostatische hypotensie, duizeligheid | Alpha-1 blockade — falls risk in elderly |
| Vaak voorkomend | Dry mouth, blurred vision | Mild anticholinergic |
| Vaak voorkomend | Misselijkheid, braken | — verbetert de verdraagzaamheid van metformine. |
| Less common | Headache, nasal congestion | Alpha-1 blockade |
| Less common | Weight gain (modest) | Less than mirtazapine or paroxetine |
| Zeldzaam | Priapism (1 in 1,000–10,000) | Persistent erection > 4 h is a urological emergency — mechanism is alpha-1 blockade interfering with detumescence; men should be counselled and report immediately |
| Zeldzaam | QT-verlenging | Dose-related; caution with other QT-prolonging drugs |
| Zeldzaam | Serotonin syndrome | See interactions |
Geneesmiddelinteracties
Absolute contraindications: MAOIs (14-day washout).
Additive sedation: alcohol, benzodiazepines, opioids, antihistamines, sedating antipsychotics — main interaction concern in older adults.
QT-verlenging: caution with citalopram (high dose), ondansetron, methadone, fluoroquinolones.
CYP3A4 substrate: levels rise with strong inhibitors (ketoconazole, ritonavir, clarithromycin) — reduce dose or avoid.
Antihypertensiva: additive orthostasis with alpha-blockers, doxazosin, prazosin, terazosin.
Why Trazodone for Insomnia?
Trazodone has become the most-prescribed off-label sleep medication in many countries despite very thin formal sleep-disorder evidence. The reasons are pragmatic:
- Heavy sedation at low dose (25–100 mg)
- No physiological dependence or rebound insomnia (unlike benzodiazepines / Z-drugs)
- No DEA scheduling
- Low overdose toxicity
- Generic and inexpensive
- Useful when SSRI-induced insomnia complicates depression treatment
Limitations: orthostatic falls (especially in older adults), priapism risk in men, and limited objective data on sleep-architecture preservation. Daytime grogginess can persist with low-dose 100 mg use.
Veelgestelde vragen
How long does Trazonil take to work for sleep?
Sedation begins within 1–2 hours of taking the dose. Take 30 minutes before intended bedtime.
Will Trazonil help with depression at low dose?
No — antidepressant effect requires 150–400 mg/day in divided doses. Bedtime 25–100 mg is purely a hypnotic dose.
Is Trazonil safer than zolpidem (Ambien) or benzodiazepines for sleep?
Different risk profile. Trazodone has no dependence potential and far lower overdose risk, but more orthostasis, falls, priapism (rare), and daytime grogginess. The right choice depends on patient age, fall risk, sex (priapism in men), and history of substance use.
What is priapism and how worried should I be?
Priapism is a persistent erection unrelieved by ejaculation, usually painful, lasting more than 4 hours. It is a urological emergency — without prompt treatment, permanent erectile dysfunction can result. Trazodone-related priapism is rare (1 in 1,000–10,000) but real. Men starting trazodone should be told to seek emergency care for any erection lasting more than 4 hours.
Can I drink alcohol on Trazonil?
Avoid — additive sedation and orthostasis. Combining trazodone with alcohol significantly increases sedation and fall risk.
Does Trazonil cause sexual dysfunction?
Less than SSRIs. Mechanism is different — the 5-HT2A blockade does not cause SSRI-style sexual side effects. Priapism in men is the rare specific concern.
Can I stop Trazonil abruptly?
Better to taper, but discontinuation syndrome is much milder than SSRIs / SNRIs. Tapering over 1–2 weeks is usually sufficient.
Is Trazonil safe in pregnancy?
Limited data — not first-line. Discuss individually with the prescriber.
Can Trazonil cause weight gain?
Modest weight gain over months — less than mirtazapine, paroxetine, or olanzapine. Not a major concern at hypnotic doses.
How should Trazonil be stored?
Store at 15–30 °C in the original blister packaging away from moisture and sunlight. Keep out of reach of children — trazodone is much safer in overdose than TCAs but still medically significant.
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