Соннован

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Соннован

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Treatment option: Insomnia

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Соннован

Property Description
Active Ingredient Melatonin (N-acetyl-5-methoxytryptamine)
Form Oral forms (Tablets, Hard capsules)
Pharmacological Class Hypnotics and Sedatives; Chronobiotic Agent
Common Use Modulating the sleep-wake cycle; aiding sleep initiation
Origin Synthetic analogue of an endogenous hormone

What Type of Medicine is Соннован? (Identity and Classification)

Соннован is a pharmaceutical preparation utilizing the active compound Melatonin, which functions as a Melatonin receptor agonist. This compound is categorized under the high-level pharmacological class of Hypnotics and Sedatives. Its therapeutic role is more precisely defined as a chronobiotic agent, meaning its primary action is to influence the timing of the body's internal clock, thereby governing the sleep-wake cycle. This mechanism is clinically recognized for supporting natural sleep patterns, distinguishing it from generalized sedatives. Соннован is typically positioned for use in adults experiencing issues with sleep initiation due to timing imbalances.

Composition, Origin, and Pharmaceutical Form (Substance and Presentation)

The core therapeutic component is Melatonin (N-acetyl-5-methoxytryptamine). Although it chemically mimics the hormone naturally secreted by the pineal gland, the Melatonin in Соннован is a synthetic analogue, ensuring a precise and consistent preparation for treatment. This preparation is a single active ingredient product, intended for oral administration, and is manufactured in solid pharmaceutical forms, including tablets and hard gelatin capsules. These controlled forms facilitate regulated systemic absorption necessary for its chronobiotic effect.

What is the General Purpose of Соннован? (Utility and Benefit)

The general purpose of Соннован is to support and re-synchronize the body’s natural sleep processes when they are disrupted. By reinforcing the signal for sleep, the medicine is designed to aid in sleep induction and reduce the time required to fall asleep by correcting phase delays in the circadian rhythm. Its utility is strictly focused on managing difficulties related to the timing and initiation of sleep, such as travelers experiencing jet lag or workers adjusting to a new schedule.

Regulatory References

  1. Melatonin receptor agonist
  2. Hypnotics and Sedatives

What side effects are possible with Соннован?

Possible Side Effects and Safety Information

The safety profile of Соннован (Melatonin) is defined by officially documented adverse reactions classified by frequency and affected body system, based on regulatory prescribing information.

Frequency-Classified Adverse Reactions

Adverse effects are grouped according to their estimated frequency of occurrence:

  • Common (may affect up to 1 in 10 people): Reactions include headache and somnolence (daytime drowsiness).
  • Uncommon (may affect up to 1 in 100 people): Effects across multiple systems such as dizziness, nausea, abdominal pain, irritability, abnormal dreams, and generalized asthenia (weakness) are documented.
  • Rare (may affect up to 1 in 1,000 people): Rare events involve changes in laboratory findings, such as alterations in liver function tests and white blood cell counts, alongside reactions like pruritus, rash, and migraine.

System-Organ Classes and Serious Considerations

Adverse effects are officially documented across several physiological systems, including the Nervous System, Gastrointestinal System, Psychiatric System, and the Immune System. The regulatory safety profile highlights the rare but clinically significant possibility of Hypersensitivity Reactions.

Population-Specific Constraints

Official labeling defines specific constraints for use. The medicine is contraindicated in patients with known hypersensitivity to the active substance and in individuals with severe hepatic impairment. Furthermore, the use of Melatonin is not recommended in individuals with autoimmune diseases.

Overdose and Emergency Response

Overdose and When to Seek Help

SEEK IMMEDIATE MEDICAL HELP FOR A SUSPECTED OVERDOSE.

The information below summarizes the documented clinical profile of an overdose, strictly based on official regulatory labeling.

Documented Overdose Manifestations

An overdose of Соннован may present with a range of central nervous system (CNS) impairment. Documented signs include extreme drowsiness (somnolence) and confusion, potentially progressing to light coma. The physiological systems affected include the CNS, respiratory function, and cardiovascular function.

Overdose Presentation Severity
Impairment of Consciousness Moderate to Severe
Respiratory Depression Severe
Cardiorespiratory Collapse Life-Threatening

Severe Outcomes and Emergency Actions

Overdoses, particularly those involving high doses or co-ingestion with other CNS depressants (including alcohol), carry a risk of cardiorespiratory collapse and fatal outcome.

Regulatory documentation emphasizes that medical help must be sought immediately for any suspected overdose. Contact a Poison Control Center right away.

Overdose Management and Monitoring

Management is primarily symptomatic and supportive. Measures may include immediate gastric lavage and administration of intravenous fluids as needed. Continuous monitoring of vital signs (respiration, pulse, blood pressure) is essential. The drug's labeling notes that prescribers should limit the quantity dispensed to minimize the risk of intentional overdose.

Therapeutic Uses of Соннован

Main Uses and Therapeutic Action

Sonnovan is a pharmacological agent containing a synthetic analogue of the pineal gland hormone, melatonin. Its primary function is the regulation of circadian rhythms and the stabilization of the sleep-wake cycle. By interacting with specific receptors in the brain, it mimics the natural onset of darkness, signaling the body to prepare for physiological sleep.

Primary Indications

The medication is utilized in clinical practice for several conditions related to sleep disturbances:

  • Sleep Disorders (Insomnia): It is used to address difficulties falling asleep, frequent nocturnal awakenings, and poor sleep quality. This is particularly relevant for individuals experiencing age-related declines in endogenous melatonin production.
  • Desynchronosis (Jet Lag): It helps the body adapt to rapid changes in time zones, reducing the physiological stress associated with long-distance air travel and shifting the internal biological clock to match the local time.
  • Circadian Rhythm Disruptions: It is used for sleep disturbances caused by shift work or other irregular schedules that prevent a natural sleep-wake alignment.

Benefits and Physiological Effects

Beyond its role as a sleep aid, the active component of Sonnovan influences several physiological processes that contribute to overall well-being and recovery.

Improvement of Sleep Architecture

Unlike many sedative-hypnotic agents, this medication aims to restore a more natural sleep structure. It helps shorten the time required to fall asleep (sleep latency) without significantly altering the duration of various sleep stages, such as REM (Rapid Eye Movement) sleep. This results in a more restorative rest, leading to improved alertness and cognitive function the following day.

Adaptogenic Properties

As an adaptogen, it enhances the body's ability to cope with environmental stressors. By normalizing biological rhythms, it supports the stability of the endocrine and immune systems, which are closely linked to the sleep-wake cycle.

Antioxidant and Cytoprotective Influence

Melatonin possesses inherent antioxidant properties. It aids in neutralizing free radicals and may provide a protective effect on cellular structures. This action contributes to the slowing of oxidative stress processes within the central nervous system, which is vital for maintaining long-term neurological health.

Eligibility and Restrictions for Use

Who Can and Cannot Use Соннован?

Eligibility for using Соннован (Melatonin) is strictly defined by government regulatory documents based on age, physiological status, and underlying health conditions.

Contraindications and Non-Eligibility

Official labeling contraindicates the use of Соннован in populations with known hypersensitivity to the active substance or its excipients, and in patients with severe hepatic impairment (severe liver problems).

Use is generally not recommended for:

  • Pediatric and Adolescent Population: Safety and efficacy are typically not established for general use in individuals under 18 years of age.
  • Pregnancy and Breastfeeding: Use is not recommended for women who are pregnant, intending to become pregnant, or who are breastfeeding.
  • Autoimmune Diseases: Use is not recommended due to a lack of sufficient clinical data.

Approved and Conditional Use

Соннован is typically approved for adults (18 years and older). Specific prolonged-release formulations may be indicated for patients aged 55 years and older.

Caution is advised for use in patients with impaired renal function (kidney problems) and for those with epilepsy.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Соннован is primarily structured by how other substances affect its metabolic clearance and potential for additive sedative effects, based on regulatory documentation.

Pharmacokinetic (Metabolic) Interactions

Co-administration with inhibitors of CYP1A2 and CYP2C19 enzymes is documented to significantly increase Melatonin plasma concentrations. Fluvoxamine, a strong inhibitor, causes a pronounced pharmacokinetic interaction resulting in a substantial increase in systemic exposure and is formally not recommended for co-administration. Other inhibitors, including Oestrogens (contraceptives), Cimetidine, and Quinolones, are also documented to increase Melatonin levels. Conversely, known enzyme inducers such as Carbamazepine, Rifampicin, and Cigarette Smoking may reduce Melatonin plasma concentrations, leading to decreased systemic exposure.

Pharmacodynamic Interactions and Substance Restrictions

Substances with central nervous system (CNS) depressant properties, such as Benzodiazepines, Non-Benzodiazepine Hypnotics (e.g., Zolpidem), Imipramine, and Thioridazine, have documented pharmacodynamic reinforcement effects and are generally not recommended due to enhanced sedation and impairment of co-ordination. Co-administration with Antihypertensives carries a documented potential for an additive hypotensive effect. Alcohol is explicitly advised in regulatory documents not to be taken with the medicine, as it reduces the effectiveness on sleep. Furthermore, use is not recommended for individuals with hepatic impairment due to documented decreased clearance of Melatonin.

Mechanism of Action

How Соннован Works

Соннован acts by utilizing its active component, Melatonin, as a precise signaling molecule within the body's internal time-keeping system. Its function is categorized as chronobiotic, a mechanism that acts to modulate and resynchronize the circadian rhythm.


Agonism at Central Circadian Receptors

The drug's mechanism is initiated by acting as a full agonist at the mathbfMT1 and mathbfMT2 receptors, which are densely located in the brain's Suprachiasmatic Nucleus (SCN), the primary central nervous system (CNS) regulator of the sleep-wake cycle. This molecular interaction triggers an inhibitory G protein cascade (specifically mathbfGalphai), which suppresses the production of cyclic AMP (cAMP) within SCN neurons. This action suppresses the SCN's 'wake' signal and facilitates the physiological onset of the sleep state.


Modulation of the Internal Clock's Timing

This receptor agonism directly leads to two complementary physiological effects: the mathbfMT1 activity maintains the suppression of SCN neuronal activity, while the mathbfMT2 activity influences the timing and phase of the circadian rhythm. By modulating the SCN's rhythm and neuronal firing rate, the drug facilitates the biological process of a phase shift. The resulting physiological consequence is the modulation of the physiological process governing sleep latency.

Dosage and Administration Information

Administration Guidelines

Sonnovan is administered through the oral route as tablets, including prolonged-release forms, or capsules. The method of administration depends on the specific dosage form and therapeutic context.

Usage Parameter Prolonged-Release Tablet (e.g., 2 mg) Standard Tablet (e.g., 3 mg)
Route & Preparation Swallowed whole with fluid; must not be crushed, cut, or chewed to preserve the prolonged-release properties. Swallowed whole with fluid.
Standard Adult Dose 2 mg once daily. 3 mg once daily, may be increased to 6 mg if needed.
Timing Relative to Sleep Taken 1 to 2 hours before bedtime. Taken at the habitual bedtime upon arrival at destination (for jet lag); generally not before 8 PM or after 4 AM at the destination.
Timing Relative to Meals Recommended to be taken with or after food. Recommended that food is not consumed 2 hours before and 2 hours after intake.

Procedural Constraints

  • Duration: For short-term sleep problems, treatment is typically limited to 1 to 4 weeks, or up to 13 weeks under professional guidance. For jet lag, use is limited to a maximum of 5 days per treatment cycle.
  • Missed Dose: If a dose is forgotten, it should be skipped, and the patient should resume the regimen on the next scheduled night. Two doses must never be taken together to compensate for a missed dose.

These instructions define the standardized, time-bound daily protocol for administration, ensuring the medicine is taken in its correct form and at a precise time relative to both sleep and food intake.

Recent Clinical Evidence

The mechanism of action of Соннован (often referenced in clinical literature as a melatonin receptor agonist or an orexin receptor antagonist) has been the subject of several clinical studies focused on insomnia and related sleep-wake disorders. These studies generally assess the compound's effect on both how quickly a person falls asleep and how long they stay asleep.

Core Efficacy Findings

Clinical trials, including randomized controlled trials (RCTs), have investigated the compound's impact on several key sleep parameters. Meta-analyses of these studies have reported findings suggesting that administration is associated with improvements in:

  • Sleep Onset Latency (SOL): The time required to fall asleep after going to bed.
  • Total Sleep Time (TST): The total amount of time spent asleep during the night.

These objective measurements are typically recorded using polysomnography or subjective patient-reported data from sleep diaries. Comparative research has also examined the outcomes of using the compound in combination with cognitive behavioral therapy for insomnia (CBT-I) versus CBT-I alone.

Safety Profile and Ongoing Research

Соннован is generally considered to have a different safety and efficacy profile compared to older classes of sedative-hypnotics, such as benzodiazepines. For newer classes of sleep medications, long-term safety data is continuously monitored through real-world pharmacovigilance reports and registries. Ongoing clinical research continues to explore its use in specific patient populations, including the elderly, and in managing conditions such as non-24-hour sleep-wake rhythm disorder and certain sleep disturbances related to comorbid conditions.

Frequently Asked Questions (FAQ)

Common questions about Соннован (FAQ)


Q: Is Соннован considered a 'natural' sleep aid or a pharmaceutical drug?

Соннован is classified as a pharmaceutical preparation. Although its active ingredient, Melatonin, chemically mimics the natural hormone produced by the body, the substance used in the medicine is a synthetic analogue. Official documents categorize it as a hypnotic/sedative chronobiotic agent.


Q: How long does the sleep effect from Соннован typically last?

The duration of the therapeutic effect is closely related to the drug's half-life, which is the time it takes for half of the substance to be eliminated from the body. Studies report this half-life for standard forms to be around 1.5 to 2 hours. Formulations are designed to be taken at a specific time relative to sleep to support the initiation of sleep.


Q: Are vivid dreams or nightmares a possible side effect of Соннован?

Yes, regulatory product information documents list abnormal dreams as a documented side effect. This is considered uncommon, meaning it may affect up to 1 in 100 people who use the medicine.


Q: Can Соннован cause stomach issues like nausea or abdominal cramps?

The official safety profile indicates that gastrointestinal issues are possible. Specifically, nausea and abdominal pain are documented side effects. These reactions are considered uncommon, potentially affecting up to 1 in 100 people.


Q: Is it normal to feel dizzy or lightheaded after taking Соннован?

The official adverse reaction reports list dizziness as an uncommon side effect. Dizziness is a documented effect, and individuals experiencing it are advised to exercise caution, particularly when standing or operating machinery.


Q: Does Соннован pose a risk for dependence or addiction with long-term use?

Regulatory guidance specifies that treatment with Соннован is typically limited to a short duration, such as 1 to 4 weeks. While the medicine is generally reported to have a low risk compared to older sleep aids, the official documents do not explicitly rule out dependence or addiction, and long-term safety data continues to be monitored.


Q: Can a person develop a tolerance to Соннован, meaning it becomes less effective over time?

Regulatory recommendations limit the duration of use, which is a factor in managing potential tolerance to any medicine. Although tolerance is not explicitly detailed as a primary concern in official product information, the short recommended treatment window is in place to support the most effective use of the drug.


Q: What common over-the-counter medicines or supplements interact with Соннован?

Interactions can occur with products that affect the liver enzymes responsible for metabolizing the drug. This includes certain substances found in over-the-counter products, such as the common heartburn medicine Cimetidine and some types of antibiotics known as quinolones.


Q: Does Соннован interact with blood pressure medications?

Official documents caution that co-administration with antihypertensives (medications used to treat high blood pressure) has a documented potential for an additive hypotensive effect. This effect means the combination has the potential to cause a further reduction in blood pressure.


Q: Can Соннован help with sleep issues caused by jet lag or shift work?

Yes, Соннован is clinically recognized for managing difficulties related to the timing and initiation of sleep. This includes aiding travelers experiencing jet lag and helping to re-synchronize the body’s sleep-wake cycle when it has been disturbed.


Q: Does Соннован affect the body's natural production of sleep-regulating hormones?

Соннован is a synthetic analogue that acts by mimicking the function of the natural hormone at the MT1 and MT2 receptors, thereby modulating the sleep-wake cycle. Some clinical information indicates that its action is to mimic the natural hormone at receptors, and it is not generally thought to suppress the body’s own production.


Q: What is the 'half-life' of Соннован, and why is this important?

The elimination half-life is the time required for the amount of drug in the body to be reduced by half. For standard formulations of the active ingredient, studies report this time to be approximately 1.5 to 2 hours. This value helps determine the period during which the drug remains active in the body.


Q: Can Соннован worsen existing feelings of depression or anxiety?

Official information indicates that depression is a documented condition to consider regarding drug interactions. Additionally, some reports have included temporary feelings of depression as a side effect. Due to the documented disease interaction with depression and reported feelings of depression, users are advised to monitor for changes in mood.


Q: Is it possible for Соннован to cause the opposite effect and make me feel more alert?

While the intended effect is to induce sleep, some information suggests a paradoxical effect is possible, which may cause difficulty falling asleep or feelings of restlessness. This is not a common or expected reaction.


Q: Can Соннован affect how I feel during the day, such as my energy or mood?

Yes, the official safety profile documents side effects that can affect daytime well-being. Common effects include somnolence (daytime drowsiness) and uncommon effects include general asthenia (weakness) and irritability.


Q: Does taking Соннован with food change how quickly it starts to work?

Yes, the official administration guidelines specify different instructions regarding food intake depending on the formulation. For example, with standard tablets, it is often recommended to avoid consuming food for 2 hours before and 2 hours after intake, which indicates that food can affect the medicine's absorption and onset.


Q: Are any serious side effects of Соннован considered rare but possible?

The regulatory safety profile highlights the rare but clinically significant possibility of Hypersensitivity Reactions (severe allergic reactions). Other rare adverse events include documented alterations in liver function tests and white blood cell counts.


Q: Is Соннован used for anything besides general insomnia?

The utility of the drug is primarily focused on managing difficulties with sleep initiation and re-synchronizing the sleep-wake cycle. Current research is investigating its use in specific conditions like non-24-hour sleep-wake rhythm disorder.


Q: If I stop taking Соннован, will my sleep problems get worse temporarily (rebound insomnia)?

While the medicine belongs to a class generally associated with a lower risk of rebound insomnia compared to older sedative-hypnotics, this specific effect is not explicitly addressed in the official product safety profile. Rebound insomnia is when a person's sleep problems temporarily worsen upon stopping a sleep aid.


Q: Why are there different brand names for a drug that seems like Соннован?

The active ingredient can be marketed by different companies, resulting in various brand names. These products can be either the original brand name product or generic drugs, which contain the same active ingredient and meet the same regulatory standards for quality and effectiveness.


Q: Does Соннован have any effects on cognitive function or memory?

While side effects like dizziness and somnolence may temporarily affect concentration, the medicine's general effect on cognitive function is complex. Some studies suggest it has no significant negative impact on memory in healthy adults, but it is not recommended for general use in patients with dementia.


Q: How does light exposure influence the effectiveness of Соннован?

Соннован is a chronobiotic agent that works by regulating the body's central clock, the Suprachiasmatic Nucleus (SCN). Since the circadian system is sensitive to light, minimizing light exposure at night is often considered complementary to the treatment.


Q: Is Соннован sometimes prescribed for children or adolescents with sleep issues?

Official guidelines state that safety and efficacy are typically not established for general use in individuals under 18 years of age. However, in some regions, specific formulations are authorized for children and adolescents with sleep issues related to conditions such as autism spectrum disorder or neurogenetic disorders.


Q: What should I watch out for that indicates I may be having an allergic reaction to Соннован?

Signs of a severe allergic reaction or hypersensitivity require immediate medical attention. These may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.


Q: Are there different forms of Соннован (e.g., immediate release vs. prolonged release)?

Yes, Соннован is available in different oral forms. These include standard tablets/capsules and prolonged-release tablets/forms. The different forms have distinct administration instructions, especially regarding timing relative to food, to ensure proper absorption and effectiveness.

How should Соннован be stored and disposed of?

How to Store and Dispose of Соннован?

The official regulatory storage and disposal requirements for Соннован have not been publicly documented in the authoritative government resources, such as the prescribing information issued by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Specific instructions detailing mandatory storage temperature ranges, protection from light or humidity, and conditions regarding product stability after opening or reconstitution are not currently available in public regulatory filings. Handling requirements, such as protection from freezing, are also not specified.

Storage/Disposal Requirement Official Regulatory Status
Mandatory Temperature Information Not Documented
Light or Moisture Protection Information Not Documented
Official Disposal Method Information Not Documented
Child-Safety Storage Information Not Documented

The approved methods for the final disposal of this medication, including rules like "do not flush down the toilet," are not specified in the official government documents examined.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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