Suvorexant is a synthetic dual orexin receptor antagonist and an active pharmaceutical ingredient used in the treatment of insomnia. It selectively antagonizes the orexin OX1R and OX2R receptors, which are involved in the regulation of wakefulness.
FDA GSRS identifies Suvorexant with CAS No. 1030377-33-3, molecular formula C₂₃H₂₃ClN₆O₂, molecular weight approximately 450.92 g/mol, and FDA UNII 081L192FO9. PubChem identifies it as an orexin receptor antagonist and central nervous system depressant.
Suvorexant is marketed in the United States under the brand BELSOMRA. The current FDA-approved labeling indicates its use for insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
The chemical name of Suvorexant is [(7R)-4-(5-chloro-2-benzoxazolyl)hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone.
Suvorexant is also known as MK-4305, MK4305 and Belsomra. FDA GSRS identifies the substance as Suvorexant and confirms its chemical identity and formula.
Suvorexant is a small-molecule pharmaceutical compound containing a benzoxazole, diazepane, triazole and aromatic amide structural framework. PubChem classifies it as an aromatic amide, triazole, organochlorine compound, diazepine and benzoxazole derivative.
The compound has molecular formula C₂₃H₂₃ClN₆O₂ and molecular weight 450.9 g/mol. It contains one defined stereocenter in the active pharmaceutical substance.
Suvorexant is an orexin receptor antagonist used for the treatment of insomnia.
The FDA-approved indication is insomnia characterized by:
The FDA label states that Suvorexant is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Suvorexant works by blocking the activity of the orexin neuropeptide signaling system, which plays an important role in maintaining wakefulness.
It antagonizes both:
FDA pharmacology information reports binding affinities of approximately Ki = 0.55 nM for OX1R and Ki = 0.35 nM for OX2R. Blocking orexin A and orexin B signaling is believed to suppress wake drive and promote sleep.
Suvorexant is a specialized CNS pharmaceutical API. FDA chemistry documentation for the approved drug product confirms the use of HPLC for Suvorexant assay, degradates and identity testing in the drug product quality-control program.
Published analytical research has also described validated HPLC/UPLC methods for determination of Suvorexant and its process/degradation impurities.
I could not verify a current universal USP/BP/Ph. Eur. numerical API release monograph for Suvorexant itself. Therefore, unsupported assay, impurity, water and residue limits should not be inserted as universal pharmaceutical specifications.
Suvorexant API manufacturing involves controlled chemical synthesis, purification, isolation and drying. Appropriate process controls should address chemical identity, assay, related substances, residual solvents, moisture and the required stereochemical purity.
Validated chromatographic and spectroscopic methods can be used for release and stability testing.
Suvorexant is a white to pale beige solid according to reference material data. Published reference data report melting points around 131–133°C, while other chemical-reference databases report approximately 153°C. Because these values differ between sources/material descriptions, the melting point should not be treated as a universal pharmaceutical release criterion.
A commercial SDS identifies Suvorexant as a solid powder and reports water solubility as not determined.
Suvorexant should be stored in suitable pharmaceutical-grade, tightly closed packaging that protects the API from moisture, contamination and environmental exposure.
Storage conditions should ultimately be established using validated stability data for the manufactured API.
Because Suvorexant is a controlled substance in the United States, applicable regulatory and controlled-substance handling requirements should also be considered where relevant. PubChem identifies Suvorexant as a DEA Schedule IV controlled substance.
Typical API documentation may include:
A qualified Suvorexant API manufacturer should maintain controlled synthesis, validated analytical procedures and complete batch traceability.
Particular attention should be given to identity, assay, related substances, residual solvents, stereochemical purity and physical properties to ensure consistent pharmaceutical-grade material.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Melting Point | Approximately 131–133°C |