Meta Information
ID:ramelteon
Name:Ramelteon
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-07-02T06:42:50Z
Model
phase-b-newfiles-claude-opus-4.8
Interactions
Target id:
/intervention/fluvoxamine
Target name:
Fluvoxamine
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluvoxamine strongly blocks CYP1A2 and raises ramelteon exposure roughly 190-fold, greatly increasing sedation.
Actionable advice:
Ramelteon should not be used with fluvoxamine.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Ramelteon tablets should not be used in combination with fluvoxamine.
Label source:
fda_label
Action type:
avoid
Target id:
/dietary/alcohol-acute
Target name:
Alcohol (Acute Consumption)
Severity:
major
Interaction type:
adverse
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Alcohol adds to ramelteon's sedative effect and impairs performance.
Actionable advice:
Alcohol should not be consumed while taking ramelteon.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Since the intended effect of ramelteon is to promote sleep, patients should be cautioned not to consume alcohol when using ramelteon tablets... Use of the products in combination may have an additive effect.
Label source:
fda_label
Action type:
avoid
Target id:
/class/cyp3a4-strong-inhibitors
Target name:
Ketoconazole (strong CYP3A4 inhibitor)
Severity:
moderate
Interaction type:
pharmacokinetic
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Strong CYP3A4 inhibitors raise ramelteon levels.
Actionable advice:
Ramelteon is best used cautiously with strong CYP3A4 inhibitors such as ketoconazole.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Ramelteon tablets should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole.
Label source:
fda_label
Action type:
monitor
Target id:
/class/cyp2c9-inhibitors
Target name:
Fluconazole (strong CYP2C9 inhibitor)
Severity:
moderate
Interaction type:
pharmacokinetic
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluconazole raises ramelteon exposure by about 150%.
Actionable advice:
Ramelteon is best used cautiously with strong CYP2C9 inhibitors such as fluconazole.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
The AUC0-inf and Cmax of ramelteon was increased by approximately 150% when ramelteon was coadministered with fluconazole.
Label source:
fda_label
Action type:
monitor
Target id:
/class/broad-spectrum-inducers
Target name:
Rifampin and other strong CYP inducers
Severity:
moderate
Interaction type:
diminishing
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Strong CYP inducers like rifampin cut ramelteon exposure by ~80%, reducing its effectiveness.
Actionable advice:
Reduced sleep benefit can be expected, and an alternative may be warranted with strong inducers.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Efficacy may be reduced when ramelteon tablets are used in combination with strong CYP enzyme inducers such as rifampin.
Label source:
fda_label
Action type:
informational_none
Target id:
/class/cns-depressants
Target name:
Other sedatives / CNS depressants
Severity:
moderate
Interaction type:
adverse
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combining ramelteon with other sedating drugs increases drowsiness and next-day impairment.
Actionable advice:
Stacking sedatives is best avoided, and caution about driving the next morning is warranted.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Additive CNS depression with other sedative-hypnotics/CNS depressants is an expected pharmacodynamic effect of a sleep-promoting agent.
Label source:
Class inference
Action type:
monitor