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Suvorexant | CAS No: 1030377-33-3 | GMP-certified suppliers
A medication that supports individuals with insomnia by helping improve sleep onset and maintenance, offered for reliable sourcing across major North American markets.
Therapeutic categories
Central Nervous System AgentsCentral Nervous System DepressantsCytochrome P-450 CYP3A InhibitorsCytochrome P-450 CYP3A SubstratesCytochrome P-450 CYP3A4 SubstratesCytochrome P-450 CYP3A4 Substrates (strength unknown)
Generic name
Suvorexant
Molecule type
small molecule
CAS number
1030377-33-3
DrugBank ID
DB09034
Approval status
Approved drug, Investigational drug
ATC code
N05CM19
Primary indications
- Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance
Product Snapshot
- Oral small‑molecule product supplied as film‑coated or coated tablets
- Used for management of insomnia related to sleep onset and sleep maintenance difficulties
- Approved in the United States and Canada, with additional investigational activity noted
Clinical Overview
Suvorexant (CAS 1030377-33-3) is an orexin receptor antagonist approved for the treatment of insomnia characterized by difficulty with sleep onset or sleep maintenance. It is an N,N‑dialkyl‑m‑toluamide derivative and functions within the broader group of central nervous system depressants and hypnotic agents used to modulate arousal pathways rather than directly inducing sleep.
Its therapeutic effect is mediated through selective dual antagonism of the OX1R and OX2R receptors. By preventing orexin A and orexin B from activating these receptors, suvorexant reduces signaling from wake-promoting neurons in the lateral hypothalamus. These neurons are physiologically active during wakefulness and cease firing during sleep. Inhibiting the orexin system decreases reinforcement of arousal networks, thereby facilitating sleep initiation and maintenance.
Suvorexant is administered orally and is primarily metabolized by CYP3A enzymes, consistent with its classification as a CYP3A substrate. Concomitant use with strong CYP3A inhibitors increases systemic exposure, while strong CYP3A inducers may reduce plasma concentrations. It is also characterized as a P-glycoprotein inhibitor, which may influence the disposition of co-administered substrates. The compound exhibits central nervous system activity consistent with its pharmacologic class, and residual sedation, next-day somnolence, and impaired driving performance are established safety considerations. Use at the lowest effective dose and caution in patients with compromised respiratory function are standard clinical safety practices.
Nonclinical data have identified dose-related central nervous system effects consistent with orexin blockade. Suvorexant is not recommended for individuals with narcolepsy due to the risk of exacerbating underlying orexin pathway dysfunction. Brand usage is most commonly associated with formulations used in major markets for chronic insomnia management.
For API procurement, emphasis should be placed on verifying stereochemical integrity, control of process-related impurities, and demonstration of compliance with regional regulatory specifications for hypnotic agents metabolized by CYP3A pathways.
Its therapeutic effect is mediated through selective dual antagonism of the OX1R and OX2R receptors. By preventing orexin A and orexin B from activating these receptors, suvorexant reduces signaling from wake-promoting neurons in the lateral hypothalamus. These neurons are physiologically active during wakefulness and cease firing during sleep. Inhibiting the orexin system decreases reinforcement of arousal networks, thereby facilitating sleep initiation and maintenance.
Suvorexant is administered orally and is primarily metabolized by CYP3A enzymes, consistent with its classification as a CYP3A substrate. Concomitant use with strong CYP3A inhibitors increases systemic exposure, while strong CYP3A inducers may reduce plasma concentrations. It is also characterized as a P-glycoprotein inhibitor, which may influence the disposition of co-administered substrates. The compound exhibits central nervous system activity consistent with its pharmacologic class, and residual sedation, next-day somnolence, and impaired driving performance are established safety considerations. Use at the lowest effective dose and caution in patients with compromised respiratory function are standard clinical safety practices.
Nonclinical data have identified dose-related central nervous system effects consistent with orexin blockade. Suvorexant is not recommended for individuals with narcolepsy due to the risk of exacerbating underlying orexin pathway dysfunction. Brand usage is most commonly associated with formulations used in major markets for chronic insomnia management.
For API procurement, emphasis should be placed on verifying stereochemical integrity, control of process-related impurities, and demonstration of compliance with regional regulatory specifications for hypnotic agents metabolized by CYP3A pathways.
Identification & chemistry
| Generic name | Suvorexant |
|---|---|
| Molecule type | Small molecule |
| CAS | 1030377-33-3 |
| UNII | 081L192FO9 |
| DrugBank ID | DB09034 |
Pharmacology
| Summary | Suvorexant is a dual antagonist of the orexin OX1R and OX2R receptors, blocking the actions of orexin A and B produced in the lateral hypothalamus. By reducing orexin‑mediated reinforcement of arousal pathways, it decreases wakefulness rather than directly inducing sleep. This modulation of arousal circuits supports its use in insomnia characterized by difficulty initiating or maintaining sleep. |
|---|---|
| Mechanism of action | Suvorexant is a dual antagonist of orexin receptors OX1R and OX2R. It exerts its pharmacological effect by inhibiting binding of neuropeptides orexin A and B, also known as hypocretin 1 and 2, that are produced by neurons in the lateral hypothalamus. These neurons control the wake-promoting centers of the brain and are active during wakefulness, especially during motor activities, and stop firing during sleep. By inhibiting the reinforcement of arousal systems, suvorexant use causes a decrease in arousal and wakefulness, rather than having a direct sleep-promoting effect. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Orexin receptor type 1 | Humans | antagonist |
| Orexin receptor type 2 | Humans | antagonist |
ADME / PK
| Absorption | Peak concentrations occur at a median Tmax of 2 hours under fasted conditions. Ingestion of suvorexant with a high-fat meal has no effect on AUC or Cmax, but may delay Tmax by approximately 1.5 hours. Mean absolute bioavailability of 10 mg is 82%. |
|---|---|
| Half-life | Mean half life is approximately 12 hours. |
| Protein binding | Suvorexant is extensively bound (>99%) to human plasma proteins and does not preferentially distribute into red blood cells. It binds to both human serum albumin and alpha1-acid glycoprotein. |
| Metabolism | Suvorexant is primarily metabolized by cytochrome-P450 3A4 enzyme (CYP3A4) with a minor contribution from CYP2C19. Major circulating metabolites are suvorexant and a hydroxy-suvorexant metabolite, which is not expected to be pharmacologically active. There is potential for drug-drug interactions with drugs that inhibit or induce CYP3A4 activity. |
| Route of elimination | Approximately 66% is eliminated in feces and 23% is eliminated in urine. |
| Volume of distribution | Mean volume of distribution is approximately 49 litres. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity support conventional oral solid formulations, potentially benefiting from solubility‑enhancing excipients.
- As a small‑molecule solid API, it is generally stable under standard handling conditions, with typical precautions for moisture and light control.
- Oral use requires consideration of known grapefruit interactions due to CYP3A modulation, which may influence labeling and co‑administration guidance.
Regulatory status
| Lifecycle | Patent protection in the United States extends from 2029 through 2033, indicating the API remains in a mid‑to‑late patent‑protected phase. With current commercialization limited to the US and Canada, market maturity is moderate and shaped primarily by North American regulatory and competitive conditions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Suvorexant is supplied by a single originator company, with branded products marketed primarily in the United States and Canada and limited presence elsewhere. Current U.S. patents extend through 2029–2033, indicating that the molecule remains under active protection. These timelines suggest that broad generic competition has not yet emerged and is unlikely until closer to patent expiry. |
|---|
Safety
| Toxicity | Dose-related somnolence and CNS depression are the most common adverse effects associated with the use of suvorexant. It has also been shown to impair driving skills and may increase the risk of falling asleep while driving. Next-day impairments are found to be highest if suvorexant is taken with less than a full night of sleep remaining, with higher doses, or if co-administered with other CNS depressants or CYP3A inhibitors. Complex behaviours such as sleep driving, preparing and eating food, and making phone calls have been reported in association with the use of hypnotics such as suvorexant. A dose-dependant increase in suicidal ideation has been observed, especially in patients with a previous diagnosis of depression. Sleep paralysis, hypnagogic/hypnopompic hallucinations including vivid and disturbing perceptions, and mild cataplexy have also been reported. There are no adequate studies in pregnant women to ensure its safety during pregnancy or breast feeding. |
|---|
High Level Warnings:
- CNS effects include dose‑related somnolence, psychomotor impairment, and complex sleep‑related behaviors
- Risk amplified by co‑administration with CNS depressants or CYP3A inhibitors
- Reports include next‑day residual sedation, sleep paralysis, hallucinations, and mild cataplexy, with dose‑dependent emergence of suicidal ideation in susceptible populations
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Suvorexant is a type of Hypnotics and sedatives
Hypnotics and sedatives belong to the pharmaceutical API category that plays a crucial role in the field of medicine. These compounds are specifically designed to induce sleep, reduce anxiety, and promote relaxation in patients. With their sedative properties, hypnotics and sedatives are commonly prescribed to treat sleep disorders, insomnia, and certain psychiatric conditions.
Pharmaceutical companies produce hypnotics and sedatives as active pharmaceutical ingredients (APIs), which are the key components responsible for the desired therapeutic effects. These APIs are carefully synthesized and formulated to ensure optimal efficacy and safety in patients. Common examples of hypnotics and sedatives include benzodiazepines, barbiturates, and non-benzodiazepine sedative-hypnotics.
The development of hypnotics and sedatives involves rigorous research and testing to ensure their effectiveness and minimize potential side effects. These APIs work by targeting specific receptors in the central nervous system (CNS), such as GABA receptors, which help regulate neuronal activity and promote sedation. By modulating these receptors, hypnotics and sedatives can produce a calming effect, induce sleep, and alleviate symptoms of anxiety and restlessness.
It is important to note that the use of hypnotics and sedatives should be carefully monitored by healthcare professionals, as they can have potential side effects, such as drowsiness, impaired coordination, and dependence. Additionally, these medications may interact with other drugs, necessitating caution and proper dosage adjustments.
In summary, hypnotics and sedatives are a vital category of pharmaceutical APIs used to promote sleep, reduce anxiety, and induce relaxation. Their precise mechanisms of action on the CNS receptors contribute to their therapeutic effects, making them valuable tools in managing sleep disorders and certain psychiatric conditions.
Suvorexant API manufacturers & distributors
Compare qualified Suvorexant API suppliers worldwide. We currently have 4 companies offering Suvorexant API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Guangzhou Green Cross Pha... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 15 products |
| PharmaZell | Producer | Germany | India | CoA, FDA, GDP, GMP, MSDS, WC, WHO-GMP | 31 products |
When sending a request, specify which Suvorexant API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Suvorexant API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Suvorexant API
Sourcing
What matters most when sourcing GMP-grade Suvorexant?
When sourcing GMP‑grade Suvorexant, compliance with U.S. and Canadian regulatory requirements is essential. Because supply is limited to a single originator and the compound remains patent‑protected through 2029–2033, confirming lawful procurement channels is critical. Verification of GMP documentation and traceability helps ensure the material aligns with the originator’s quality standards.
Which documents are typically required when sourcing Suvorexant API?
Request the core API documentation set: CoA (3 companies), GMP (3 companies), MSDS (3 companies), FDA (2 companies), BSE/TSE (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Suvorexant API?
Known or reported manufacturers for Suvorexant: Apino Pharma Co., Ltd., Global Pharma Tek, PharmaZell. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Suvorexant API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Suvorexant manufacturers?
Audit reports may be requested for Suvorexant: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Suvorexant API on Pharmaoffer?
Reported supplier count for Suvorexant: 3 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Suvorexant API?
Production countries reported for Suvorexant: India (2 producers), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Suvorexant usually hold?
Common certifications for Suvorexant suppliers: CoA (3 companies), GMP (3 companies), MSDS (3 companies), FDA (2 companies), BSE/TSE (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Suvorexant (CAS 1030377-33-3) used for?
Suvorexant is used for the treatment of insomnia characterized by difficulty with sleep onset or sleep maintenance. It works by antagonizing the OX1R and OX2R orexin receptors, reducing wake‑promoting signaling from the hypothalamus. This decreases arousal to help facilitate sleep initiation and continuity.
Which therapeutic class does Suvorexant fall into?
Suvorexant belongs to the following therapeutic categories: Central Nervous System Agents, Central Nervous System Depressants, Cytochrome P-450 CYP3A Inhibitors, Cytochrome P-450 CYP3A Substrates, Cytochrome P-450 CYP3A4 Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Suvorexant mainly prescribed for?
The primary indications for Suvorexant: Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Suvorexant work?
Suvorexant is a dual antagonist of orexin receptors OX1R and OX2R. It exerts its pharmacological effect by inhibiting binding of neuropeptides orexin A and B, also known as hypocretin 1 and 2, that are produced by neurons in the lateral hypothalamus. These neurons control the wake-promoting centers of the brain and are active during wakefulness, especially during motor activities, and stop firing during sleep. By inhibiting the reinforcement of arousal systems, Suvorexant use causes a decrease in arousal and wakefulness, rather than having a direct sleep-promoting effect.
What should someone know about the safety or toxicity profile of Suvorexant?
Suvorexant causes dose‑related somnolence, psychomotor impairment, and next‑day residual sedation, with risks heightened when combined with CNS depressants or CYP3A inhibitors. Complex sleep‑related behaviors, sleep paralysis, hallucinations, and mild cataplexy have been reported, and suicidal ideation may emerge in susceptible individuals at higher doses. Caution is advised in patients with compromised respiratory function and in those taking interacting drugs. It is contraindicated in narcolepsy due to the potential to worsen orexin pathway dysfunction.
What are important formulation and handling considerations for Suvorexant as an API?
Important considerations include managing Suvorexant’s low aqueous solubility and moderate lipophilicity, which may require solubility‑enhancing excipients in oral solid formulations. The solid API is generally stable but should be protected from moisture and light during handling and storage. Because Suvorexant is metabolized mainly by CYP3A4, formulation and labeling should account for interactions with CYP3A modulators, including grapefruit products.
Is Suvorexant a small molecule?
Suvorexant is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Suvorexant?
Oral Suvorexant is generally stable as a small‑molecule solid API when stored under standard conditions. Usual precautions for moisture and light control apply, and its low aqueous solubility may necessitate use of solubility‑enhancing excipients in formulated products. No additional stability concerns beyond these typical considerations are noted in the provided information.
Regulatory
Where is Suvorexant approved or in use globally?
Suvorexant is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Suvorexant right now?
Suvorexant is authorized for use in both the United States and Canada. Patent protection is determined by jurisdiction‑specific filings and statutory terms, which define the period of market exclusivity for the active ingredient.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Suvorexant procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Suvorexant. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Suvorexant included in the PRO Data Insights coverage?
PRO Data Insights coverage for Suvorexant: 46 verified transactions across 27 suppliers and 18 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Suvorexant?
Market report availability for Suvorexant: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
