Agomelatin Glenmark

What Is Agomelatin Glenmark and What Is It Used For?

Agomelatin Glenmark is a prescription antidepressant containing agomelatine 25 mg. It is used to treat major depressive disorder (MDD) in adults. Agomelatine has a unique dual mechanism of action, acting as a melatonin MT1/MT2 receptor agonist and a serotonin 5-HT2C receptor antagonist.

Agomelatin Glenmark belongs to a class of medications called melatonergic antidepressants. Unlike traditional antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-noradrenaline reuptake inhibitors (SNRIs), agomelatine works through a fundamentally different pharmacological pathway. It simultaneously stimulates the brain's melatonin receptors (MT1 and MT2) and blocks serotonin 5-HT2C receptors, creating a dual mechanism that addresses both the neurochemical imbalances and the circadian rhythm disruptions commonly seen in major depressive disorder.

Depression is a persistent mood disorder that profoundly affects daily functioning. Symptoms vary between individuals but commonly include deep sadness, feelings of worthlessness, loss of interest in previously enjoyed activities, sleep disturbances, a sense of sluggishness, anxiety, and changes in weight or appetite. The World Health Organization (WHO) estimates that more than 280 million people worldwide suffer from depression, making it one of the leading causes of disability globally.

The expected benefit of Agomelatin Glenmark is to reduce and eventually eliminate the symptoms associated with your depression. Clinical trials have demonstrated that agomelatine is effective in treating moderate to severe major depressive episodes in adults, with particular benefits for patients experiencing sleep disturbances and circadian rhythm disruption as part of their depressive illness. A meta-analysis published in The Lancet (Cipriani et al., 2018) confirmed agomelatine's efficacy compared to placebo in treating major depression.

Agomelatine's effect on melatonin receptors helps to resynchronize disrupted circadian rhythms, which are frequently disturbed in depression. This chronobiological action contributes to improved sleep quality and daytime alertness, often among the earliest improvements patients notice. The 5-HT2C antagonism component increases noradrenaline and dopamine release specifically in the frontal cortex, supporting improvements in mood, motivation, and cognitive function.

What Should You Know Before Taking Agomelatin Glenmark?

Before taking Agomelatin Glenmark, your doctor must verify that your liver is functioning properly through blood tests. The medication is contraindicated in patients with hepatic impairment and must not be combined with fluvoxamine or ciprofloxacin. Special caution is needed for patients with obesity, diabetes, or bipolar disorder.

Before starting treatment with Agomelatin Glenmark, it is essential to have an open discussion with your healthcare provider about your complete medical history. There are several important factors that may influence whether this medication is appropriate for you, and your doctor needs comprehensive information to make the safest prescribing decision.

Contraindications

You must not take Agomelatin Glenmark in the following situations:

• Allergy to agomelatine or any of the other ingredients in the tablet (see What Does Agomelatin Glenmark Contain?)
• Hepatic impairment – if your liver is not functioning properly, as agomelatine is extensively metabolized by the liver
• Concurrent use of fluvoxamine – another antidepressant that is a potent CYP1A2 inhibitor, which would dramatically increase agomelatine blood levels
• Concurrent use of ciprofloxacin – an antibiotic that is a moderate CYP1A2 inhibitor, which would also significantly increase agomelatine exposure

Warnings and Precautions

There are several clinical situations where Agomelatin Glenmark requires careful consideration and additional monitoring. Discuss the following with your doctor before starting or continuing treatment:

• Liver-affecting medications: If you are taking any other drugs known to affect the liver, your doctor should assess the combined hepatic risk before prescribing agomelatine
• Obesity or overweight: Being overweight or obese may increase the risk of liver-related adverse effects; your doctor should provide specific guidance
• Diabetes: Patients with diabetes may require additional monitoring; consult your doctor for tailored advice
• Elevated baseline liver enzymes: If your liver enzymes are already elevated before treatment, your doctor will determine whether agomelatine is a suitable option for you
• Bipolar disorder: If you have a history of bipolar disorder or develop manic symptoms (periods of abnormally high irritability and emotional excitement), inform your doctor before starting or continuing treatment
• Dementia: Your doctor will perform an individual assessment of suitability if you have dementia
• Age 75 and older: The efficacy of agomelatine has not been established in patients aged 75 years and over; it should therefore not be used in this population

Liver Function Test Schedule

Follow-up blood tests must be performed at the following intervals:

Based on the evaluation of these tests, your doctor will decide whether you should begin using or continue using Agomelatin Glenmark. If the dose is increased to 50 mg, the monitoring schedule restarts from the beginning. Additional tests may be performed whenever your doctor considers it necessary.

Suicidal Thoughts and Self-Harm

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, as these medications take time to work – usually about 2 weeks, sometimes longer. You may be more likely to experience these thoughts:

• If you have previously had thoughts of self-harm or suicide
• If you are a young adult under 25 years of age. Clinical studies have shown that young adults (under 25) with psychiatric conditions treated with antidepressants have an increased risk of suicidal thoughts and self-harm behavior

Contact your doctor or go to the nearest hospital immediately if you have any thoughts of self-harm or suicide. It may be helpful to tell a relative or close friend that you are depressed, and ask them to read this information. You can also ask them to tell you if they think your condition is worsening or if they notice changes in your behavior.

Children and Adolescents

Agomelatin Glenmark is not recommended for use in children and adolescents under 18 years of age. For children under 7 years, there is insufficient data available. For children and adolescents aged 7 to 17 years, the safety and efficacy of agomelatine have not been established, and the medication should not be used in this age group.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medication. There is limited data on the use of agomelatine during pregnancy, and it is not recommended unless clearly necessary and under direct medical supervision.

Breastfeeding should be discontinued if you are taking Agomelatin Glenmark, as it is not known whether agomelatine passes into human breast milk. Your doctor will help you weigh the benefits and risks of treatment during pregnancy or breastfeeding.

Driving and Operating Machinery

You may experience dizziness or drowsiness during treatment, which can affect your ability to drive or operate machinery. Make sure your reactions are normal before driving or using machines. You are responsible for assessing whether you are in a condition to drive a motor vehicle or perform tasks that require focused attention.

How Does Agomelatin Glenmark Interact with Other Drugs?

Agomelatin Glenmark must not be combined with fluvoxamine or ciprofloxacin, which are CYP1A2 inhibitors that dramatically increase agomelatine blood levels. Use caution with propranolol and enoxacin. Smoking more than 15 cigarettes per day may reduce the effectiveness of the medication. Alcohol should be avoided.

Drug interactions with agomelatine are primarily related to its metabolism through the cytochrome P450 enzyme system, specifically CYP1A2 and to a lesser extent CYP2C9. Any substance that significantly inhibits these enzymes can increase agomelatine concentrations in the blood, potentially leading to increased side effects and liver toxicity. It is essential to inform your doctor about all medications, supplements, and herbal products you are currently taking.

Major Interactions (Contraindicated)

Minor Interactions (Use with Caution)

Smoking and Alcohol

Smoking: Tobacco smoke is a potent inducer of the CYP1A2 enzyme. If you smoke more than 15 cigarettes per day, the metabolism of agomelatine is significantly accelerated, potentially reducing its therapeutic effectiveness. Inform your doctor if you are a heavy smoker, as dose adjustments may be necessary.

Alcohol: Alcohol consumption is not recommended during treatment with Agomelatin Glenmark. Alcohol places additional stress on the liver, and given the requirement for liver monitoring with agomelatine, combining the two increases the risk of hepatotoxicity. Furthermore, alcohol is a central nervous system depressant that can worsen depression symptoms and counteract the beneficial effects of antidepressant therapy.

What Is the Correct Dosage of Agomelatin Glenmark?

The recommended dose is one 25 mg tablet taken once daily at bedtime. If needed, your doctor may increase the dose to 50 mg (two 25 mg tablets) taken together at bedtime. The tablet should be swallowed whole with water, and can be taken with or without food. Treatment should continue for at least 6 months.

Always take Agomelatin Glenmark exactly as your doctor or pharmacist has instructed. Check with your doctor or pharmacist if you are unsure about any aspect of your treatment. The dosing regimen for agomelatine is straightforward, but it is important to follow it precisely to maximize therapeutic benefit while maintaining safety.

Adults

In most patients with depression, Agomelatin Glenmark begins to exert its antidepressant effects within two weeks of starting treatment. However, the full therapeutic benefit may take 4 to 6 weeks to become apparent. Your depression should be treated for a sufficiently long period – at least 6 months – to ensure you are free from symptoms.

Your doctor may continue prescribing Agomelatin Glenmark even after you feel better, in order to prevent your depression from returning. Depression is a condition with a high relapse rate, and maintenance therapy is an important part of comprehensive treatment. Clinical guidelines, including those from the National Institute for Health and Care Excellence (NICE), recommend continuing antidepressant treatment for at least 6 months after remission of symptoms, and longer in patients with recurrent episodes.

If your doctor increases the dose to 50 mg, the liver function monitoring schedule restarts. New blood tests should be taken at the start of the higher dose and then periodically at approximately 3, 6, 12, and 24 weeks.

Children and Adolescents

Elderly Patients

Patients with Kidney Problems

If you have kidney problems, your doctor will make an individual assessment of whether it is safe for you to take Agomelatin Glenmark. In clinical studies, no significant changes in agomelatine pharmacokinetics were observed in patients with mild to moderate renal impairment, but caution is still warranted.

Switching from an SSRI/SNRI to Agomelatin Glenmark

If your doctor wants you to switch from a previous SSRI or SNRI antidepressant to Agomelatin Glenmark, they will advise you on how to taper your previous medication when starting agomelatine. During the transition, you may experience discontinuation symptoms associated with withdrawal from the previous medication, even if the dose is gradually reduced. These discontinuation symptoms may include:

• Dizziness and numbness or tingling sensations
• Sleep disturbances and insomnia
• Agitation or anxiety
• Headache, nausea, and vomiting
• Tremor

These symptoms are usually mild to moderate and resolve on their own within a few days. Importantly, if treatment with Agomelatin Glenmark begins while the dose of your previous antidepressant is being tapered, discontinuation symptoms from the old medication should not be confused with a lack of early effect from agomelatine. Always discuss the best approach to switching with your doctor.

Missed Dose

If you forget to take a dose of Agomelatin Glenmark, do not take a double dose to make up for the missed one. Simply skip the missed dose and take your next dose at the usual time the following evening. The calendar printed on the blister strip of certain pack sizes (14, 28, 84, and 98 tablets) can help you track when you last took a tablet.

Overdose

If you take more Agomelatin Glenmark than prescribed, or if someone else (such as a child) has accidentally ingested the medication, contact your doctor, hospital, or poison control center immediately for risk assessment and advice.

Experience with agomelatine overdose is limited. Reported symptoms of overdose include upper abdominal pain, drowsiness, fatigue, agitation, anxiety, tension, dizziness, reduced blood oxygen levels (cyanosis), and general discomfort. There is no specific antidote for agomelatine overdose; treatment is symptomatic and supportive.

What Are the Side Effects of Agomelatin Glenmark?

The most common side effect of agomelatine is headache, affecting more than 1 in 10 patients. Common side effects include dizziness, drowsiness, insomnia, nausea, diarrhea, and elevated liver enzymes. Serious but rare side effects include liver injury (hepatitis, jaundice), severe skin reactions, and hallucinations. Liver function must be monitored regularly.

Like all medicines, Agomelatin Glenmark can cause side effects, although not everyone experiences them. Most side effects are mild to moderate in severity. They typically occur during the first two weeks of treatment and are usually temporary, resolving as your body adjusts to the medication. The side effect profile of agomelatine is generally considered more favorable than that of many other antidepressants, particularly regarding sexual dysfunction and weight gain.

A notable advantage of agomelatine compared to SSRIs and SNRIs is its generally favorable profile regarding sexual side effects. In clinical trials and real-world studies, agomelatine has been associated with significantly lower rates of sexual dysfunction than SSRIs, SNRIs, and tricyclic antidepressants. A systematic review by Kennedy et al. (2016) in the Journal of Clinical Psychiatry confirmed that agomelatine's rate of treatment-emergent sexual dysfunction was comparable to placebo and significantly lower than that of other antidepressant classes.

Weight gain is another area where agomelatine performs favorably. While weight gain is listed as a common side effect, the extent of weight change observed in clinical trials was generally modest and less pronounced than that seen with many other antidepressants, particularly mirtazapine, paroxetine, and tricyclic antidepressants.

How Should You Store Agomelatin Glenmark?

Store Agomelatin Glenmark out of sight and reach of children. No special temperature requirements, but keep in the original packaging as the tablets are moisture-sensitive. Do not use after the expiry date printed on the carton and blister.

Proper storage of medication is important to maintain its effectiveness and safety. Follow these guidelines for storing Agomelatin Glenmark:

• Keep out of sight and reach of children – store in a secure location where children cannot access the medication
• Check the expiry date – do not use after the date printed on the carton and blister pack after "EXP." The expiry date refers to the last day of that month
• No special temperature storage – there are no specific temperature requirements for this medication
• Keep in original packaging – the tablets are moisture-sensitive, so store them in their original blister packaging to protect from humidity
• Proper disposal – do not dispose of medications through wastewater or household waste. Return unused medications to your pharmacist for proper disposal to protect the environment

What Does Agomelatin Glenmark Contain?

Each film-coated tablet contains 25 mg of agomelatine as the active substance. The tablets are yellow, oblong, biconvex (9.0 mm x 4.5 mm), and are available in blister packs of 14, 28, 30, 84, 90, or 98 tablets.

Active Substance

Each film-coated tablet contains 25 mg agomelatine (as agomelatine/citric acid 1:1 co-crystal).

Inactive Ingredients (Excipients)

The other ingredients in Agomelatin Glenmark tablets are:

• Tablet core: Microcrystalline cellulose with silicon dioxide, mannitol, povidone K30, crospovidone type A, sodium stearyl fumarate, magnesium stearate, colloidal anhydrous silicon dioxide, stearic acid
• Film coating: Hypromellose, macrogol 6000, titanium dioxide (E171), talc, and yellow iron oxide (E172)

Appearance and Pack Sizes

Agomelatin Glenmark 25 mg film-coated tablets are yellow, oblong, and biconvex with dimensions of 9.0 mm x 4.5 mm. They are available in blister packs containing 14, 28, 30, 84, 90, or 98 tablets. Not all pack sizes may be marketed in your country.

Frequently Asked Questions About Agomelatin Glenmark

References and Sources

Editorial Team