Suvorexant
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2014
- First approval year
- 2014
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Suvorexant
- Molecular weight
- 450.93
- Structure (SMILES)
- Cc1ccc(-n2nccn2)c(C(=O)N2CCN(c3nc4cc(Cl)ccc4o3)CC[C@H]2C)c1
- belsomra
- Belsomra
- suvorexant component of belsomra
- Suvorexant component of belsomra
- 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.
- ATC classification codes
- N05CJ01
Sources for recorded values
- CAS registry numbers
- 1030377-33-3
- ChEMBL ID
- CHEMBL1083659
- InChIKey
- JYTNQNCOQXFQPK-MRXNPFEDSA-N
- PubChem compound IDs
- 24965990
- RxNorm IDs (RxCUI)
- 1547099
- FDA ingredient codes (UNII)
- 081L192FO9
- Applicant
- MERCK SHARP DOHME
- Approval date
- 13 Aug 2014
- Application number
- NDA204569
- 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
- United States (FDA)
- Approved
- Pharmacology name
- suvorexant
- Type
- Synthetic organic
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- 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
- 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
- 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
- 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
- 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.
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And 3 more, listed on the interactive page.
- Dose
- 10 mg
- How often
- Once nightly
- Do not exceed 20 mg daily
- Take within 30 minutes of going to bed
- 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
- 0006-0005
- 0006-0033
- 0006-0325
- 0006-0335
- Recorded assays
- 240
- Active assays
- 41
- Confirmatory
- Other
- Sleep Aids, Pharmaceutical
- Orexin Receptor Antagonists
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
- 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)
In development for (16)
- Alcohol abuse Phase 2
- Alcohol dependence Phase 2
- Alzheimer disease Phase 2
- Autism Phase 2
- Autism spectrum disorder Phase 2
- Chronic obstructive pulmonary disease Phase 1
- Delirium Phase 3
- Major depressive disorder Phase 2
- Nicotine dependence Phase 1
- Obstructive sleep apnea syndrome Phase 1
- Opiate dependence 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