Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist used in the treatment of major depressive disorder. It also induces a phase advance of sleep, body temperature decline, and the onset of melatonin release.
The available evidence relating to the safety of agomelatine use in pregnancy is highly limited. Animal studies performed by the manufacturer have not identified adverse effects on embryo/fetal, pre- or postnatal development. There are no published cases of agomelatine use in human pregnancy.
Where agomelatine is being used in the treatment of psychiatric conditions, the risk to both woman and fetus from relapse of the maternal condition as a consequence of discontinuing the drug or reducing the dose during pregnancy should be carefully considered.
Due to the lack of safety data, additional fetal monitoring may be considered appropriate in cases where agomelatine exposure has occurred during pregnancy. Although there are no data specific to agomelatine, as with any centrally acting drug, neonatal withdrawal may be expected following chronic use or use near term. It may therefore be advisable to monitor infants for signs of withdrawal after delivery.
Exposure to agomelatine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.