Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ROZEREM ® is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study… FDA label
Also known as TAK-375, Rozerem, Sinequan®, Neurontin®, Ambien
Ramelteon · 19 trials · 11 indications
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated.
Time to sleep onset as determined by polysomnography
The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Maximum observed serum concentration (Cmax) is the peak serum concentration of ramelteon and its metabolite (M-II) after administration, obtained directly from the serum concentration-time curve.
Tmax: Time to reach the maximum serum concentration (Cmax) of ramelteon and its metabolite M-II, equal to time (hours) to Cmax.
Area under the serum concentration-time curve from time 0 to time of last quantifiable concentration (tlqc) of ramelteon and its metabolite M-II, calculated using the linear trapezoidal rule.
Area under the serum concentration-time curve from time zero extrapolated to infinity for ramelteon and its metabolite M-II. The terminal area from the last quantifiable concentration (lqc) to infinity is calculated by approximation: lqc / terminal elimination rate constant (λz).
Apparent oral clearance of drug from the serum calculated as: CL/F = Dose / Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC\[0-inf\]).
The rate at which ramelteon and its metabolite M-II are eliminated from the body, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
Terminal phase elimination half-life (T1/2) for ramelteon and its metabolite M-II is the time required for half of the drug to be eliminated from the serum, calculated as T1/2 = natural logarithm of 2 (ln\[2\]) / Terminal elimination rate constant (λz).
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as Vz/F = Apparent oral clearance (CL/F) / Terminal elimination rate constant (λz).
| Arm | Type | Description |
|---|---|---|
| Ramelteon 4 mg QD | EXPERIMENTAL | - |
| Placebo QD | PLACEBO_COMPARATOR | - |
| Ramelteon | EXPERIMENTAL | Ramelteon 8 mg oral before bedtime |
| sugar pill | PLACEBO_COMPARATOR | - |
| Ramelteon 8 mg QD | EXPERIMENTAL | - |
| Zopiclone 7.5 mg QD | ACTIVE_COMPARATOR | - |
| Ramelteon 16 mg QD | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Ramelteon 1 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Doxepin 3 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Doxepin Placebo QD | EXPERIMENTAL | - |
| Ramelteon Placebo QD and Doxepin 3 mg QD | ACTIVE_COMPARATOR | - |
| Ramelteon 4 mg QD and Gabapentin 400 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Gabapentin 800 mg QD | EXPERIMENTAL | - |
| Ramelteon 8 mg QD and Gabapentin Placebo QD | EXPERIMENTAL | - |
| Gabapentin 800 mg QD | ACTIVE_COMPARATOR | - |
| Ramelteon 2 mg QD | EXPERIMENTAL | - |
| Ramelteon 16 mg QD and Placebo QD | EXPERIMENTAL | - |
| Ramelteon 16 mg QD or Placebo QD | EXPERIMENTAL | - |
| Children Ramelteon 4 mg | EXPERIMENTAL | Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon. |
| Children Ramelteon 8 mg | EXPERIMENTAL | Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon. |
| Adolescents Ramelteon 4 mg | EXPERIMENTAL | Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon. |
| Adolescents Ramelteon 8 mg | EXPERIMENTAL | Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon. |
| Healthy Adult Ramelteon 8 mg | ACTIVE_COMPARATOR | Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon. |
| Name | Type | Description |
|---|---|---|
| Ramelteon | DRUG | Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks. |
| Placebo | DRUG | Ramelteon placebo-matching tablets, orally, once daily for up to 5 weeks. |
| rozerem | DRUG | Ramelteon (rozerem) 8mg oral before bedtime |
| Zopiclone | DRUG | Zopiclone 7.5 mg, tablets, orally, once daily for up to 28 nights. |
| Ramelteon and doxepin | DRUG | Ramelteon 8 mg, tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks. |
| Doxepin | DRUG | Ramelteon placebo-matching tablets, orally, once daily and doxepin 3 mg, liquid, orally, once daily for up to five weeks. |
| Ramelteon and gabapentin | DRUG | Ramelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week. |
| Gabapentin | DRUG | Ramelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week. |
| Ramelteon and Placebo | DRUG | Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2. |
| Ramelteon or Placebo | DRUG | Ramelteon 16 mg, tablet, orally, once daily for Periods 1 or 2 and ramelteon placebo-matching tablets, orally, once daily for Periods 1 or 2. |
| Ramelteon 8 mg | DRUG | - |
| Zopiclone 7.5 mg | DRUG | - |
Inclusion Criteria: * A female subject of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study. * Has a body mass index between 18 and 34, inclusive. * Based on sleep history, the subject has had chronic insomnia for ...
Ramelteon is being studied for insomnia and other sleep disorders, including chronic insomnia, sleep initiation and maintenance disorders, obstructive sleep apnea, and sleep disorder. It has also been evaluated in balance and chronic obstructive pulmonary disease. It is a small molecule developed by Takeda Pharmaceutical Company Limited.
Ramelteon is an agonist of the melatonin receptors MTNR1A and MTNR1B. By acting on these targets, it is designed to influence sleep regulation. This mechanism underlies its investigation in insomnia and related sleep conditions.
Ramelteon is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda has sponsored the clinical trial program evaluating the drug across sleep and other indications.
Ramelteon is in Phase 3 development. It is an investigational small molecule and has not been approved based on the information available. Its trial program includes Phase 1, Phase 2, and Phase 3 studies, all of which are completed.
Ramelteon has been studied in five completed trials, including NCT00914862, a Phase 1 pharmacokinetic and safety study in adolescents with insomnia and healthy adults; NCT00756002, a Phase 3 safety and efficacy study in chronic insomnia; NCT00755508, a Phase 2 trial of Ramelteon combined with gabapentin; and NCT00755495, a Phase 2 trial of Ramelteon and doxepin.