INN monograph
Agomelatine
Melatonergic antidepressant · POM
Verified · Updated 01 Aug 2026 · Source: Local active-ingredient clinical extract; Batch A alphabetical research (INN; confirm vs SmPC/local guidelines); PubChem; Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- Patients with hepatic impairment
- hypersensitivity to the active substance or to any of the excipients
- concomitant use of potent CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin.
Precautions
- Liver function tests should be performed in all patients at initiation of treatment and then periodically after around 6wks, 12 wks, and 24 wks and thereafter when clinically indicated.
- Agomelatine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
- Caution should be exercised when prescribing agomelatine to patients above 65yrs and those with renal impairment due to unavailability of adequate clinical data on these patient groups.
- Extra cautions should also be taken in patients with history of mania or hypomania [discontinued if a patient develops manic symptoms].
- Therapy should be discontinued if the increase in serum transaminases exceeds 3 times upper limit of normal and liver function tests should be per-formed regularly until serum transaminases return to normal.
- The drug may affect ability to drive or operate a machine as it causes drowsiness.
Point of care
Dosing
Adult
25 mg OD orally before or food at bed-time. The dose may be increased to 50mg OD if there is no improvement of symptoms after 2wks. Treatment needs to proceed for at least 6 months.
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Caution.
- CrCl 0–120: See renal_dose_adjustment; confirm product SmPC.
Hepatic
Contraindicated HI; LFT monitoring mandatory.
Safety
Drug interactions
- Pregnancy category: No clinical data on exposure in pregnancy and lactation are available hence caution should be exercised when prescribing to pregnant and breastfeeding women.
- This is the first melatonergic antidepressant drug.
Safety
Adverse effects
- Common: headache, dizziness, somnolence, insomnia, migraine, nausea, diarrhea, constipation, upper abdominal pain, hyperhidrosis, back pain, fatigue, increased serum transaminases.
- Uncommon: paraesthesia, blurred vision, erythematous rash
- hepatitis [rare]
Use
Indications
- Therapeutic use is agent- and indication-specific within the class (Therapeutic agent (verify pharmacological class)).
- Use according to culture results, national guidelines (Kenya STG/EML where applicable) and the current product SmPC.
- Major depressive episodes in adults.
Pharmacology
Mode of action
It is a melatonergic agonist [MT1 and MT2 receptors] and 5-HT2C antagonist.
Full mechanism text
It is a melatonergic agonist [MT1 and MT2 receptors] and 5-HT2C antagonist. Mechanism is agent-specific. At receptor, enzyme, ion channel, transporter or microbial target level, the drug alters a physiological or pathological pathway to produce its therapeutic effect. Confirm precise molecular mechanism in current SmPC / pharmacology reference for this INN before high-stakes decisions.
ADME
Pharmacokinetics & PD
| Onset | Product-specific |
|---|---|
| Duration | Product-specific |
| Route | See product SmPC |
| Elimination | are product-specific. Consider food effects, protein binding, hepatic CYP/UGT |
| Half-life | when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC. |
Full PK/PD text
Absorption, distribution, metabolism and excretion are product-specific. Consider food effects, protein binding, hepatic CYP/UGT metabolism, renal clearance and half-life when adjusting for organ impairment, age and drug interactions. Verify parameters in the current SmPC.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| Valdoxan | Laboratoire Servier | Standard Commercial Pack | — |
Special populations
Pregnancy & lactation
Pregnancy
Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist.
Lactation
Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Diet
Food & alcohol
- Administration / food notes Bedtime dosing.
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; Batch A alphabetical research (INN; confirm vs SmPC/local guidelines); PubChem; Professional class pharmacology (Therapeutic agent (verify pharmacological class))
Last reviewed: 01 Aug 2026
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.