Ramelteon
Treatment for Insomnia
Typical Dosage: 8 mg at bedtime
Effectiveness
55%
Safety Score
70%
Clinical Trials
49
Participants
10K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
70
DangerousModerateSafe
Treatment Details
Dosage Range
8 mg at bedtime
Time to Effect
30-60 minutes
Treatment Duration
long-term
Evidence Quality
HIGHNumber Needed to Treat (NNT)
12(Treat 12 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
35(Treat 35 patients to see 1 additional serious adverse event)
Confidence Score
80%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$100
Monitoring:$150
Side Effect Mgmt:$20
Total Annual:$270
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOODICER
$75,000/QALY
QALYs Gained
0.09
Outcome-Based Costs
Cost per Responder
$540
Cost per Remission
$3,375
Prescription Access Economics
Annual Societal Loss per Patient
$370
Cost of prescription-only barriers (visits, time, admin, price premium)
Physician Visit Cost
$150/year
Time Cost
$50/year
Travel + wait time
Insurance Admin Cost
$20/year
Prior auth, claims
Rx Price
$100/year
Potential OTC Price
$50/year
Estimated if OTC available
Early Treatment Benefit
+0.01 QALYs
From faster OTC access
Risk Assessment
Misuse Risk
LOWMissed Diagnosis Risk
LOWRamelteon Outcomes
for Insomnia
Efficacy Outcomes
Overall Effectiveness
+55%
Response Rate
+50%
Remission Rate
+8%
Common Side Effects
Somnolence
+5%
Dizziness
+4%
Nausea
+3%
Active Clinical Trials
1 active trial recruiting for Ramelteon in Insomnia
A Study of Ramelteon in Chinese Patients With Chronic Insomnia
NCT06512363NOT YET RECRUITINGPHASE3
280 participants
INTERVENTIONAL
Started: Aug 1, 2024
Completed Clinical Trials
15 completed trials for Ramelteon in Insomnia
Pharmacokinetic and Safety of Ramelteon Between Adolescents With Insomnia and Healthy Adults
NCT00914862COMPLETEDPHASE1
56 participants
INTERVENTIONAL
Overland Park, United States +1 more
Started: Nov 1, 2009
Ramelteon in Adults With Chronic Insomnia
NCT00671567COMPLETEDPHASE3
848 participants
INTERVENTIONAL
Birmingham, United States +69 more
Started: Dec 1, 2002
Efficacy of Ramelteon on Transient Insomnia in Healthy Adults
NCT00671398COMPLETEDPHASE3
289 participants
INTERVENTIONAL
Palm Springs, United States +11 more
Started: Dec 1, 2002
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
NCT02058992COMPLETED
3.34K participants
OBSERVATIONAL
Started: Jul 1, 2010
Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia
NCT00671255COMPLETEDPHASE3
829 participants
INTERVENTIONAL
Columbiana, United States +114 more
Started: Dec 1, 2002
Study of Efficacy of Ramelteon in Adults With Chronic Insomnia
NCT00671125COMPLETEDPHASE3
405 participants
INTERVENTIONAL
Birmingham, United States +24 more
Started: Jan 1, 2003
Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -
NCT02153086COMPLETED
236 participants
OBSERVATIONAL
Osaka, Japan +1 more
Started: Mar 1, 2011
Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia
NCT00656994COMPLETEDPHASE3
122 participants
INTERVENTIONAL
Birmingham, United States +28 more
Started: Jan 1, 2003
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
NCT02669082COMPLETEDPHASE4
26 participants
INTERVENTIONAL
Kitakyushu, Japan +6 more
Started: May 9, 2017
Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
NCT02156271COMPLETEDPHASE4
75 participants
INTERVENTIONAL
Started: Jul 1, 2007
Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
NCT00247390COMPLETEDPHASE3
451 participants
INTERVENTIONAL
Birmingham, United States +47 more
Started: Jul 1, 2005
Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
NCT00414102COMPLETEDPHASE4
552 participants
INTERVENTIONAL
Phoenix, United States +51 more
Started: Oct 1, 2006
Efficacy of Ramelteon in Subjects With Chronic Insomnia
NCT00671086COMPLETEDPHASE3
1.21K participants
INTERVENTIONAL
Birmingham, United States +121 more
Started: Feb 1, 2003
Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease
NCT00325728COMPLETEDPHASE2
74 participants
INTERVENTIONAL
Alabaster, United States +71 more
Started: Mar 21, 2006
Safety of Ramelteon in Elderly Subjects
NCT00568789COMPLETEDPHASE4
33 participants
INTERVENTIONAL
Costa Mesa, United States +5 more
Started: Jun 1, 2006
Showing 20 of 49 total trials