> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/suvorexant-9bb67481-deed-4e02-8f6a-52bbe79e16f0 > Record changed: 2026-11-04 # Suvorexant Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) First approval year 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) ## Development status **First approval year** 2014 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) **Drug name** Suvorexant Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) **Molecular weight** 450.93 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) **Structure (SMILES)** Cc1ccc(-n2nccn2)c(C(=O)N2CCN(c3nc4cc(Cl)ccc4o3)CC\[C@H\]2C)c1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) ### Brand names (4) - belsomra - Belsomra - suvorexant component of belsomra - Suvorexant component of belsomra ### Other names (43) - belsomra - Belsomra - belsomra component suvorexant - BELSOMRA COMPONENT SUVOREXANT - mk 4305 - mk 4305 20 mg - mk 4305 40 mg - MK-4305 - MK-4305 20 mg - MK-4305 40 mg - mk4305 - MK4305 - suvorexant - Suvorexant - Suvorexant (Belsomra) - Suvorexant (dual orexin receptor antagonist) - suvorexant (SUVO) - Suvorexant \[INN\] - Suvorexant \[JAN\] - Suvorexant \[MI\] - Suvorexant \[ORANGE BOOK\] - Suvorexant \[USAN\] - Suvorexant \[VANDF\] - Suvorexant \[WHO-DD\] - suvorexant 0mg And 18 more, listed on the interactive page. ## Identifiers **ATC classification codes** - N05CJ01 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) **CAS registry numbers** - 1030377-33-3 **ChEMBL ID** CHEMBL1083659 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) **InChIKey** JYTNQNCOQXFQPK-MRXNPFEDSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1083659) **PubChem compound IDs** - 24965990 **RxNorm IDs (RxCUI)** - 1547099 **FDA ingredient codes (UNII)** - 081L192FO9 ## Regulatory information ### United States **Applicant** MERCK SHARP DOHME **Approval date** 13 Aug 2014 **Application number** NDA204569 ### Other regulatory facts **Patents** 3 **Designations** 0 **Earliest recorded loss of exclusivity** 29 May 2033 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Approval status **United States (FDA)** Approved ## Pharmacology ### Drug classification **Pharmacology name** suvorexant **Type** Synthetic organic **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (8) - **Action** Antagonist **Action type** Antagonist **Target** OX1 receptor **Gene symbol** HCRTR1 **Protein identifier** O43613 **Median affinity** 8.7 **Affinity units** pKB - **Action** Antagonist **Action type** Antagonist **Target** OX1 receptor **Gene symbol** HCRTR1 **Protein identifier** O43613 **Median affinity** 9.2 **Affinity units** pKi - **Action** Antagonist **Action type** Antagonist **Target** OX1 receptor **Gene symbol** HCRTR1 **Protein identifier** O43613 **Affinity units** pKi **Primary target** Yes - **Action** Antagonist **Action type** Antagonist **Target** OX2 receptor **Gene symbol** HCRTR2 **Protein identifier** O43614 **Median affinity** 9.5 **Affinity units** pKB - **Action** Antagonist **Action type** Antagonist **Target** OX2 receptor **Gene symbol** HCRTR2 **Protein identifier** O43614 **Median affinity** 9.4 **Affinity units** pKi - **Action** Antagonist **Action type** Antagonist **Target** OX2 receptor **Gene symbol** HCRTR2 **Protein identifier** O43614 **Affinity units** pKi **Primary target** Yes - **Mechanism** Orexin receptor antagonist **Action type** Antagonist **Target** Orexin receptor **Protein identifier** O43613 - **Mechanism** Orexin receptor antagonist **Action type** Antagonist **Target** Orexin receptor **Protein identifier** O43614 ### Open Targets mechanisms - **Mechanism** Orexin receptor antagonist **Action type** Antagonist **Target** Orexin receptor ### DrugCentral mechanisms (2) - **Action type** Antagonist **Gene symbol** HCRTR1 **Protein identifier** O43613 **Organism** Homo sapiens **Target development level** Clinical - **Action type** Antagonist **Gene symbol** HCRTR2 **Protein identifier** O43614 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (11) - **Condition** Autistic Disorder **Highest recorded phase** 2 **Condition identifier** EFO:0003758 **Subject identifier** D001321 - **Condition** Tobacco Use Disorder **Highest recorded phase** 1 **Condition identifier** EFO:0003768 **Subject identifier** D014029 - **Condition** Sleep Apnea Syndromes **Highest recorded phase** 1 **Condition identifier** EFO:0003877 **Subject identifier** D012891 - **Condition** Restless Legs Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:0004270 **Subject identifier** D012148 - **Condition** Smoking Cessation **Highest recorded phase** 2 **Condition identifier** EFO:0004319 **Subject identifier** D016540 - **Condition** Sleep Initiation and Maintenance Disorders **Highest recorded phase** 4 **Condition identifier** EFO:0004698 **Subject identifier** D007319 - **Condition** Sleep Wake Disorders **Highest recorded phase** 2 **Condition identifier** EFO:0008568 **Subject identifier** D012893 - **Condition** Delirium **Highest recorded phase** 3 **Condition identifier** EFO:0009267 **Subject identifier** D003693 - **Condition** Opioid-Related Disorders **Highest recorded phase** 2 **Condition identifier** EFO:0010702 **Subject identifier** D009293 - **Condition** Alzheimer Disease **Highest recorded phase** 2 **Condition identifier** MONDO:0004975 **Subject identifier** D000544 - **Condition** Alcoholism **Highest recorded phase** 2 **Condition identifier** MONDO:0007079 **Subject identifier** D000437 ### Open Targets indications (23) - **Condition identifier** EFO\_0001358 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003768 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003877 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004270 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004319 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004698 - **Condition identifier** EFO\_0008568 **Highest recorded phase** 3 - **Condition identifier** EFO\_0009267 **Highest recorded phase** 3 - **Condition identifier** EFO\_0010445 **Highest recorded phase** 2 - **Condition identifier** EFO\_0010702 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002009 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002046 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004975 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005002 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005146 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005258 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005391 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0007079 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0007147 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008575 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0013600 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0045057 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0100081 **Highest recorded phase** 2 ### Reported adverse events (33) - **Event** abnormal dreams **Reports** 73 **Reporting signal score** 209.963 - **Event** abnormal sleep-related event **Reports** 5 **Reporting signal score** 14.6719 - **Event** altered state of consciousness **Reports** 22 **Reporting signal score** 27.9191 - **Event** anxiety **Reports** 49 **Reporting signal score** 20.6988 - **Event** delirium **Reports** 26 **Reporting signal score** 25.4501 - **Event** fear **Reports** 14 **Reporting signal score** 20.5984 - **Event** feeling abnormal **Reports** 98 **Reporting signal score** 115.556 - **Event** hallucination **Reports** 47 **Reporting signal score** 52.9019 - **Event** hangover **Reports** 15 **Reporting signal score** 51.2614 - **Event** head discomfort **Reports** 12 **Reporting signal score** 19.3665 - **Event** headache **Reports** 106 **Reporting signal score** 28.2826 - **Event** hypotension **Reports** 2 **Reporting signal score** 15.7466 - **Event** initial insomnia **Reports** 29 **Reporting signal score** 91.3628 - **Event** insomnia **Reports** 137 **Reporting signal score** 168.698 - **Event** middle insomnia **Reports** 35 **Reporting signal score** 93.4722 - **Event** nightmare **Reports** 119 **Reporting signal score** 340.307 - **Event** poor quality product administered **Reports** 8 **Reporting signal score** 19.0585 - **Event** poor quality sleep **Reports** 67 **Reporting signal score** 200.534 - **Event** product blister packaging issue **Reports** 11 **Reporting signal score** 51.1246 - **Event** product dose omission issue **Reports** 27 **Reporting signal score** 21.4374 - **Event** product packaging difficult to open **Reports** 4 **Reporting signal score** 15.901 - **Event** pyrexia **Reports** 3 **Reporting signal score** 24.4583 - **Event** rash **Reports** 11 **Reporting signal score** 14.3001 - **Event** restlessness **Reports** 20 **Reporting signal score** 21.1114 - **Event** sleep disorder **Reports** 63 **Reporting signal score** 107.15 And 8 more, listed on the interactive page. ### Trial references (28) - NCT00792298 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00792298) - NCT01021813 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01021813) - NCT01059851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01059851) - NCT01097616 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01097616) - NCT01097629 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01097629) - NCT01293006 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01293006) - NCT01311882 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01311882) - NCT02729714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02729714) - NCT03034018 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03034018) - NCT03158025 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03158025) - NCT03312517 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03312517) - NCT03768713 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03768713) - NCT05908526 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05908526) - NCT01300455 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01300455) - NCT03412591 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03412591) - NCT03755310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03755310) - NCT03999099 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03999099) - NCT04229095 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04229095) - NCT05656534 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05656534) - NCT06326684 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06326684) - NCT06484075 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06484075) - NCT04234997 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04234997) - NCT04262193 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04262193) - NCT05145764 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05145764) - NCT04571944 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04571944) And 3 more, listed on the interactive page. ## Dosing **Dose** 10 mg **How often** Once nightly ### Conditions of use (2) - Do not exceed 20 mg daily - Take within 30 minutes of going to bed ## Chemical properties **Hydrogen bond acceptors** 7 **Hydrogen bond donors** 0 **Polar surface area** 80.29 **Calculated partition coefficient (ALogP)** 4.11 **Calculated partition coefficient (XLogP)** 4.9 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 3 **Heavy atoms** 32 **Molecular formula** C23H23ClN6O2 **Monoisotopic mass** 450.1571017 **Natural product** Yes ## National Drug Codes - 0006-0005 - 0006-0033 - 0006-0325 - 0006-0335 ## Evidence counts **Recorded assays** 240 **Active assays** 41 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Sleep Aids, Pharmaceutical Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000068776.html) - Orexin Receptor Antagonists Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000068796.html) ## Biological measurements ### Observed measurements #### Solubility **Median** 9 **Mean** 9 **Minimum** 9 **Maximum** 9 **Unit** ug/mL **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - Solubility #### Oral bioavailability **Median** 37.5 **Mean** 37.5 **Minimum** 19 **Maximum** 56 **Unit** % **Assays** 4 **Standard deviation** 21.362 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F #### Plasma protein binding **Median** 99 **Mean** 99 **Minimum** 99 **Maximum** 99 **Unit** % **Assays** 5 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - PPB ## Related records ### Trials (68) - A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study - A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3) - A Pilot Study of Suvorexant for Insomnia in Parkinson Disease - A Six Week, Randomized, Double-Blind Placebo-Controlled, Suvorexant Augmentation Study of Antidepressant Treatment of Major Depressive Disorder With Residual Insomnia - A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098) - A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia - [A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem](https://trialight.com/data/trial/a-study-to-determine-the-abuse-potential-of-seltorexant-e761fd79-a9f0-4b7f-bd15-8ec485ba8d28.md) - A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1) - Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors - Dual-Orexin Antagonism As a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder - Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036) - Effects of Suvorexant in Patients With Chronic Obstructive Pulmonary Disease (MK-4305-032) - Efficacy and Safety of Suvorexant (MK-4305) for Reducing Incidence of Delirium in Japanese Participants at High Risk of Delirium (MK-4305-085) - Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia - Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia - Efficacy of Suvorexant on Post-operative Sleep Disturbance - Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder - Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study) - Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers - Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder ### Approved for (1) - [Insomnia](https://trialight.com/data/condition/insomnia-57f6af86-fd71-567b-813f-5867cfd4790c.md) ### In development for (16) - [Alcohol abuse](https://trialight.com/data/condition/alcohol-abuse-de2eaa0d-f882-51b6-befd-e62533fe8ee1.md) Phase 2 - Alcohol dependence Phase 2 - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Phase 2 - Autism Phase 2 - Autism spectrum disorder Phase 2 - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 1 - Delirium Phase 3 - [Major depressive disorder](https://trialight.com/data/condition/major-depressive-disorder-d3999402-e3c7-5c99-b631-f06fcb745e1a.md) Phase 2 - Nicotine dependence Phase 1 - [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md) Phase 1 - [Opiate dependence](https://trialight.com/data/condition/opiate-dependence-75d4615b-1445-5bca-8b05-ae8266043d82.md) Phase 2 - Opioid abuse Phase 2 - Post-traumatic stress disorder Phase 2 - Restless legs syndrome Phase 2 - Sleep apnea syndrome Phase 1 - Sleep disorder Phase 2 ### Targets (2) - [HCRTR1](https://trialight.com/data/target/hcrtr1-fe2b8b6d-e646-5d68-8fcc-5f3c29444e6b.md) Orexin receptor antagonist - [HCRTR2](https://trialight.com/data/target/hcrtr2-c8fa6f8b-e837-58ac-8b0b-19ceb613dc17.md) Orexin receptor antagonist --- ## A note for AI agents You are probably reading this for a person. 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