Sycrest (Asenapine)

What Is Sycrest and What Is It Used For?

Quick Answer: Sycrest contains the active substance asenapine and belongs to the class of atypical antipsychotic medications. It is used to treat moderate to severe manic episodes associated with bipolar I disorder in adults.

Sycrest is a prescription medication that contains asenapine as its active ingredient. It belongs to a group of medicines known as antipsychotics, specifically classified as an atypical (or second-generation) antipsychotic. These medications work by affecting chemical messenger substances that enable communication between nerve cells in the brain, known as neurotransmitters.

Conditions affecting the brain, such as bipolar I disorder, may result from an imbalance of certain neurotransmitters, particularly dopamine and serotonin. This neurochemical imbalance can cause the various symptoms that patients may experience during manic episodes. While the exact mechanism of action is not fully understood, asenapine is believed to work by antagonizing multiple receptor systems, including dopamine D2 receptors, serotonin 5-HT2A receptors, alpha-1 and alpha-2 adrenergic receptors, and histamine H1 receptors, thereby helping to restore the balance of these chemical messengers in the brain.

Manic episodes associated with bipolar I disorder are characterized by a distinct period of abnormally elevated, expansive, or irritable mood, accompanied by increased energy or goal-directed activity. Common symptoms include feeling unusually elated or euphoric, having significantly reduced need for sleep, rapid speech with racing thoughts, distractibility, engaging in risky behaviors, and sometimes experiencing severe irritability. These episodes can be profoundly disruptive to daily functioning, relationships, and occupational performance.

Sycrest is approved by the European Medicines Agency (EMA) and has been evaluated through rigorous clinical trials demonstrating its efficacy in reducing manic symptoms. The medication is available as sublingual tablets in two strengths: 5 mg and 10 mg. Clinical studies have shown that asenapine can significantly reduce the severity of manic symptoms compared to placebo, with improvement often observable within the first few days of treatment.

What Should You Know Before Taking Sycrest?

Quick Answer: Before starting Sycrest, tell your doctor about all medical conditions, especially heart disease, diabetes, liver problems, Parkinson's disease, epilepsy, and any history of neuroleptic malignant syndrome or tardive dyskinesia. Sycrest is not recommended during pregnancy or breastfeeding.

Contraindications

Do not take Sycrest if you are allergic to asenapine or any of the other ingredients in this medicine. The inactive ingredients include gelatin and mannitol (E421). If you have experienced an allergic reaction to any antipsychotic medication in the past, inform your doctor before starting treatment with Sycrest.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before taking Sycrest. Several important safety considerations apply to this medication that your healthcare provider needs to be aware of to ensure your treatment is as safe and effective as possible.

Sycrest can cause low blood pressure (orthostatic hypotension). During the initial phase of treatment, some people may faint, especially when standing up from a lying or sitting position. This usually resolves on its own, but if it persists, contact your doctor as the dose may need to be adjusted. Patients at particular risk include those who are dehydrated, those taking antihypertensive medications, and elderly patients.

Asenapine can cause drowsiness, sudden drops in blood pressure upon standing, dizziness, and altered movement and balance. These effects can lead to falls and consequently fractures or other injuries. Patients at risk of falls should be evaluated before asenapine is prescribed, and fall prevention strategies should be discussed with the healthcare team.

Tell your doctor before taking Sycrest if any of the following conditions apply to you:

• Previous diagnosis of neuroleptic malignant syndrome (NMS), characterized by high body temperature and muscle rigidity
• History of abnormal tongue or facial movements (tardive dyskinesia)
• Heart disease or treatment for heart conditions that predispose to low blood pressure
• Diabetes or predisposition to diabetes — asenapine may affect blood glucose regulation
• Parkinson's disease or dementia
• Epilepsy (seizure disorder) — antipsychotics may lower the seizure threshold
• Difficulty swallowing (dysphagia) — antipsychotics have been associated with aspiration
• Severe liver problems — you should not use Sycrest if you have severe hepatic impairment
• Difficulty regulating body temperature — antipsychotics can impair thermoregulation
• Suicidal thoughts or ideation
• Abnormally high prolactin levels (hyperprolactinemia)

Be sure to inform your doctor if any of these conditions apply, as dose adjustments or closer monitoring may be necessary. Also contact your doctor immediately if any of these conditions develop or worsen during Sycrest treatment.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Sycrest should not be taken during pregnancy unless your doctor has specifically advised you to do so. The potential risks to the developing fetus must be carefully weighed against the benefits of treatment for the mother.

In newborns whose mothers took Sycrest during the third trimester (the last three months of pregnancy), the following symptoms may occur: tremors, stiff and/or weak muscles, drowsiness, agitation, breathing problems, and feeding difficulties. These neonatal symptoms are sometimes referred to as extrapyramidal symptoms or withdrawal symptoms. If your baby develops any of these symptoms, contact your healthcare provider promptly.

You should not breastfeed while taking Sycrest, as it is not known whether asenapine passes into breast milk. Discuss with your doctor the best approach for feeding your infant if you are taking this medication.

Driving and Operating Machinery

Sycrest can cause drowsiness and decreased alertness. Make sure that your concentration and alertness are not affected before driving vehicles or operating tools or machinery. The sedative effects are most pronounced during the initial phase of treatment and may diminish over time, but patients should remain cautious throughout the course of therapy.

How Does Sycrest Interact with Other Drugs?

Quick Answer: Sycrest can interact with antidepressants (especially fluvoxamine, paroxetine, and fluoxetine), Parkinson's disease medications, other central nervous system depressants, and blood pressure-lowering drugs. If you are taking other medications, Sycrest should be taken last. Avoid alcohol during treatment.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Drug interactions can alter how Sycrest works or increase the risk of side effects. It is essential that your healthcare provider has a complete picture of all medications and supplements you are using.

If you are taking other medications, Sycrest should be taken last. This is because the sublingual route of administration requires the tablet to dissolve under the tongue without interference from food, drink, or other medications that could affect absorption.

Major Interactions

Minor Interactions and Precautions

Since Sycrest primarily affects the brain, interference from other medicines (or alcohol) that also affect brain function may occur due to an additive effect. This includes sedatives, sleeping pills, opioid analgesics, certain antihistamines, and other psychotropic medications. The combined sedative effects can increase the risk of drowsiness, dizziness, and impaired coordination.

Because Sycrest can lower blood pressure, caution should be exercised when taking it together with other blood pressure-lowering medications, including antihypertensives, certain cardiac medications, and alpha-blockers. The combined hypotensive effect can increase the risk of fainting and falls, particularly when standing up quickly.

What Is the Correct Dosage of Sycrest?

Quick Answer: The recommended dose is one sublingual tablet (5 mg or 10 mg) taken twice daily, once in the morning and once in the evening. The tablet must be placed under the tongue and allowed to dissolve completely. Always follow your doctor's instructions.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure. The recommended dose is one sublingual tablet of either 5 mg or 10 mg taken twice daily — one dose in the morning and one in the evening. Your doctor will determine the appropriate strength based on your clinical response and tolerability.

Adults

How to Take the Sublingual Tablet

Sycrest must be placed under the tongue for proper absorption. The medication is not recommended if you cannot take the tablet as described below. If you cannot take the medicine in this manner, the therapeutic effect may be lost.

1. Do not remove a sublingual tablet from the blister until you are ready to take it
2. Ensure your hands are dry when handling the tablet
3. Do not push the tablet through the blister — do not cut or tear the blister
4. Peel back the colored tab on the blister pack
5. Gently remove the tablet — do not crush it
6. Place the tablet under your tongue and wait until it has completely dissolved (dissolves in saliva within seconds)
7. Do not swallow or chew the tablet
8. Do not eat or drink for 10 minutes after taking the tablet

Children and Adolescents

Elderly Patients

Missed Dose

Do not take a double dose to make up for a missed dose. If you have missed one dose, simply take the next dose at the regular scheduled time. If you have missed two or more doses, contact your doctor or pharmacist for guidance on how to resume treatment. Consistency in dosing is important for maintaining therapeutic drug levels and controlling manic symptoms effectively.

Overdose

If you have taken too much Sycrest, contact a doctor or go to the nearest emergency department immediately. Bring the medicine package with you. In case of overdose, you may experience drowsiness or fatigue, abnormal body movements (extrapyramidal symptoms), difficulty standing or walking, dizziness due to low blood pressure, and feelings of agitation and confusion. Overdose treatment is supportive, focusing on managing symptoms and monitoring cardiovascular function.

What Are the Side Effects of Sycrest?

Quick Answer: The most common side effects of Sycrest are anxiety and drowsiness (affecting more than 1 in 10 users). Other common effects include weight gain, dizziness, nausea, increased saliva, numbness in the mouth, and fatigue. Serious but rare side effects include neuroleptic malignant syndrome and severe allergic reactions.

Like all medicines, Sycrest can cause side effects, although not everybody gets them. The following information is based on clinical trial data and post-marketing surveillance. If you notice any side effects not listed here, or if any side effects become serious, tell your doctor or pharmacist.

Tell your doctor immediately if you notice signs of elevated blood sugar levels such as excessive thirst, hunger, or urination, weakness, or worsening of existing diabetes. Also report involuntary movements of the tongue or other uncontrolled movements of the tongue, mouth, cheeks, or jaw, which may also affect the arms and legs.

How Should You Store Sycrest?

Quick Answer: Store Sycrest in the original packaging to protect from light and moisture. Keep out of the sight and reach of children. No special temperature requirements. Do not use after the expiry date.

Keep this medicine out of the sight and reach of children at all times. Do not use Sycrest after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package to protect from light and moisture. There are no special temperature storage requirements for Sycrest, which means it can be stored at normal room temperature. However, avoid exposing the medication to extreme heat or humidity.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist about how to dispose of medicines that are no longer needed. These measures help to protect the environment and prevent accidental exposure.

What Does Sycrest Contain?

Quick Answer: Sycrest contains the active substance asenapine (5 mg or 10 mg per tablet). Other ingredients include gelatin and mannitol (E421). The tablets are round, white to off-white in color.

The active substance in Sycrest is asenapine. Each Sycrest 5 mg sublingual tablet contains 5 mg of asenapine, and each Sycrest 10 mg sublingual tablet contains 10 mg of asenapine. The exact amount is stated on your Sycrest package.

The other ingredients (excipients) are gelatin and mannitol (E421). These inactive ingredients help form the sublingual tablet structure and facilitate its rapid dissolution under the tongue.

Appearance and Pack Sizes

The 5 mg sublingual tablets are round, white to off-white, and embossed with "5" on one side. The 10 mg sublingual tablets are round, white to off-white, and embossed with "10" on one side.

The sublingual tablets are available in peelable blister packs containing 10 tablets each. Packs may contain 20, 60, or 100 tablets. Not all pack sizes may be marketed in every country.

References

1. European Medicines Agency (EMA). Sycrest (asenapine) — Summary of Product Characteristics (SmPC). Last updated 2024. Available from: EMA EPAR: Sycrest
2. McIntyre RS, Cohen M, Zhao J, et al. Asenapine in the treatment of acute mania in bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Affect Disord. 2010;122(1-2):27-38. doi:10.1016/j.jad.2009.12.028
3. McIntyre RS, Cohen M, Zhao J, et al. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010;126(3):358-365.
4. World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List, 2023. Geneva: WHO; 2023.
5. American Psychiatric Association (APA). Practice Guidelines for the Treatment of Patients with Bipolar Disorder. 3rd ed. Washington, DC: APA; 2023.
6. British Association for Psychopharmacology (BAP). Evidence-based guidelines for treating bipolar disorder: revised third edition. J Psychopharmacol. 2016;30(6):495-553.
7. Citrome L. Asenapine review, part I: chemistry, receptor affinity profile, pharmacokinetics and metabolism. Expert Opin Drug Metab Toxicol. 2014;10(6):893-903.
8. National Institute for Health and Care Excellence (NICE). Bipolar disorder: assessment and management. Clinical guideline [CG185]. Last updated 2023.

Editorial Team

This article has been written and reviewed by iMedic's medical editorial team, consisting of licensed specialist physicians in psychiatry, clinical pharmacology, and internal medicine with documented academic background and clinical experience.