To avoid any potential drug interactions, inform your healthcare provider of all medications you use before discussing ramelteon. You should not drink alcohol immediately before or after taking ramelteon. Consuming alcoholic beverages with ramelteon can increase certain side effects of this medication, such as dizziness and drowsiness.
Ramelteon is one of several medications used to treat insomnia. Others, such as doxepin, may also help you reduce the effects of sleep difficulties and benefit from better sleep health. You can learn more about the most effective treatments for insomnia in our complete guide to prescription sleeping pills, which lists everything from older-generation sleeping pills to newer insomnia treatments.
This article is for informational purposes only and does not constitute medical advice. The information contained herein is not a substitute for and should never be relied upon for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment.
Insider tips, early access and more. The efficacy of ramelteon was assessed in older adult ages 64—93 years chronic insomnia subjects enrolled in a 5-week outpatient trial with groups receiving nightly doses of ramelteon 4 mg, 8 mg, or placebo Roth et al One-week single-blind placebo periods occurred before and after the double-blind treatment period. Compared with the placebo group, the sleep diary outcomes demonstrated significantly shorter subjective sleep onset latencies for both ramelteon dose groups at week 1 and week 5, and for the 8 mg group at all three assessments.
The 8 mg group was not significantly different from the placebo group for reported total sleep time, although the 4 mg group was significant for the week 1 and 3 assessments. However, the overall treatment effect combining the two ramelteon treatment groups also resulted in significantly better total sleep time relative to the placebo group at weeks 1 and 3.
There were no significant differences between ramelteon and placebo regarding sleep quality, number of nighttime awakenings, and ease of falling back to sleep. With discontinuation, there was no evidence of rebound insomnia or withdrawal effects. A subset including of the above older adults met a criterion for severe sleep initiation difficulty with reported baselines equal to or greater than 60 minutes Mini et al In this subanalysis, subjects had been randomized to the ramelteon 8 mg group and to the placebo group.
Statistically significant improvement from baseline remained significantly better in the ramelteon group compared with the placebo group at weeks 1 through 5. By week 1 the mean reported sleep latency decreased by 7. At week 5 the improvement relative to baseline for the placebo group was The long-term nightly use of ramelteon was evaluated in a month open-label, non-placebo-controlled outpatient study of adult and elderly subjects meeting criteria for chronic insomnia DeMicco et al The adults ages 18—64 years were given ramelteon 16 mg, and the elderly subjects ages 65 and older were given 8 mg.
At 6 months, subjects remained in the study, and subjects completed the full 12 months Richardson et al a. Sleep diary data showed that in comparison with baseline sleep latency estimates, both elderly and adult subjects experienced improvement at month 1 Total sleep time estimates also showed steady improvement for elderly and adult subjects at month 1 Clinical Global Impression assessments also reflected the moderate and sustained improvement.
A single-blind 3-day placebo run-out at the end of the study showed no significant prolongation in sleep latency that would reflect rebound insomnia. The longest assessment of both objective and subjective measures in a placebo-controlled study with the nightly use of a pharmacologic agent in the treatment of chronic insomnia subjects has been reported with a 6-month ramelteon clinical trial Wang-Weigand et al A total of adults with chronic insomnia were randomized to ramelteon 8 mg or placebo groups.
Two consecutive nights of polysomnographic recording were completed at week 1 and months 1, 3, 5, and 6 of treatment, and week 1 of a single-blind placebo run-out. Subjective sleep variables were measured with morning questionnaires. Relative to placebo, the ramelteon subjects experienced statistically significantly shorter objective latency to persistent sleep throughout the 6-month study.
Subjective sleep latency also was shorter throughout the study and reached statistical significance at week 1, month 1, and month 5. There was no evidence of withdrawal or rebound insomnia on discontinuation. Although human studies examining the efficacy of ramelteon in the treatment of circadian rhythm disorders have not been presented, preliminary investigations suggest possible future applications in this clinical area. In a study with rats, the animals were entrained to a hour light-dark cycle and then subjected to an abrupt 8-hour advance phase shift.
The ability of ramelteon or melatonin to facilitate the phase shift in rat activity rhythm was compared with a vehicle control during 14 days of administration at the same time of day Hirai et al Both ramelteon and melatonin accelerated the reentrainment to the new light-dark cycle following the abrupt phase shift.
The phase-shifting effects in healthy human subjects were examined in a study of 18 subjects during a 4-period crossover study including ramelteon 4 mg and 16 mg, melatonin 5 mg, and placebo Richardson et al The ramelteon doses were effective in producing a phase advance of the endogenous circadian rhythm as indicated by the timing of the evening dim light salivary melatonin onset. In a subsequent trial, a 5-hour phase advance was imposed on 75 healthy adults who were randomized to receive ramelteon 1 mg, 2 mg, 4 mg, 8 mg, or placebo.
The subjects were confined in a sleep laboratory under low-intensity light for five nights and six days. The safety of ramelteon has been examined in numerous preclinical and clinical trials. The efficacy trials have demonstrated a lack of significant next-morning residual sedation and cognitive impairment using questionnaires and measures, such as the digit symbol substitution test and the visual analog scale for alertness.
Specific safety studies have focused on potential interactions with ethanol and selected coadministered medications, as well as abuse liability, endocrine effects, and use in special medical populations.
There is no evidence of discontinuation withdrawal symptoms. Figure 3 shows the incidence of treatment-emergent adverse events in the clinical studies Takeda Pharmaceuticals North America A broad range of safety parameters were monitored during the one-year, open-label, non-placebo-controlled study of ramelteon 16 mg adults and 8 mg older adults noted above DeMicco et al ; Richardson et al a.
No clinically meaningful changes were reported regarding vital signs, physical exams, clinical chemistry, hematology, urinalysis, and electrocardiogram trends. The testosterone levels returned to the normal range by the final visit of the study. The absence of balance difficulty due to ramelteon has been confirmed in three studies.
In each report the effects of the medication were no different from placebo, while subjects given active comparators demonstrated evidence of acute impairment in balance. A total of adult chronic insomnia subjects completed a protocol involving 14 nightly doses of placebo, ramelteon 8 mg, or zopiclone 7. On the last night the subjects slept in a laboratory setting and were awakened 1. The subjects stood on a balance platform and were assessed for sway. The ramelteon subjects were the same as the placebo group; however, the zopiclone group had a significantly worse calculated area of center of pressure on the platform Hajak et al Thirty-three older adult chronic insomnia subjects participated in a single-dose crossover study examining the effects of placebo, ramelteon 8 mg, and zolpidem 10 mg on balance.
Two hours following a bedtime dose, the subjects were awakened and assessed for balance and mobility with computerized dynamic posturography. Only on the zolpidem nights did the subjects exhibit significant impairment relative to the placebo performance Wang-Weigand et al Balance was among the outcomes investigated in an abuse liability crossover study of substance abusers given daytime ramelteon 16— mg , triazolam 0.
The effects of ramelteon on balance were no different from placebo throughout the wide dose range; however, balance impairment was noted at the higher triazolam doses Johnson et al Pharmacokinetic studies have examined the possible effects of ramelteon coadministered with commonly prescribed medications or those that are representative of hepatic isozyme inhibitors or inducers.
Overall, ramelteon was shown not to have a significant effect on the serum concentration of coadministered medications. In some cases there were statistically significant increases or decreases in the ramelteon level due to the hepatic isozyme inhibition or induction of the coadministered medication.
Medications tested that had no significant effect on the systemic exposure of ramelteon included dextromethorphan Tolbert et al a , digoxin Tolbert et al b , midazolam Karim et al b , zolpidem Karim et al a , and warfarin Karim et al b. Even with moderate changes in the ramelteon levels from coadministered medications, these interactions generally have not been regarded as clinically significant for the following reasons. Ramelteon undergoes extensive first-pass metabolism, has highly variable plasma concentrations and a wide therapeutic window, and has a flat dose-effect relationship.
That it is metabolized by several hepatic isoenzymes also limits the potential for drug interactions. The one medication that may markedly elevate the ramelteon concentration is the potent CYP1A2 isozyme inhibitor, fluvoxamine Luvox , and therefore combined use is not recommended Takeda Pharmaceuticals North America The safety of ramelteon in patients with mild-to-moderate COPD was examined in a double-blind, placebo-controlled, two-way crossover study of 26 subjects Sainati et al ; Kryger et al The oxygen saturation for each hour and for the entire night was comparable between the ramelteon 16 mg and placebo, suggesting no respiratory depressant effects in these subjects.
The mean oxygen saturation values for ramelteon 16 mg and placebo nights during non-REM sleep were A similarly designed study of 26 mild-to-moderate obstructive sleep apnea subjects apnea-hypopnea index AHI range 5 through 20 given ramelteon 16 mg and placebo on different nights showed no exacerbation of the sleep-disordered breathing AHI Oxygen saturation throughout the night and during specific sleep stages was similar for the placebo and ramelteon 16 mg nights, except for a slight increase during REM sleep for the ramelteon night.
Patients with mild, moderate, and severe renal impairment, including subjects treated with dialysis, were studied following single and multiple doses of ramelteon 16 mg Tolbert et al d.
There was no correlation between the degree of renal impairment and the systemic exposure of ramelteon. Therefore, no ramelteon dosage adjustment is recommended in patients with renal impairment. The potential for hepatic disease to increase the systemic exposure to ramelteon was demonstrated in a study of patients with mild and moderate hepatic impairment in comparison with healthy matched control subjects following administration of single and multiple doses of ramelteon 16 mg Karim et al f.
Caution is advised in using ramelteon in patients with moderate hepatic impairment, and ramelteon use is not recommended in patients with severe impairment Takeda Pharmaceuticals North America The effects of ramelteon on endocrine function in humans initially was evaluated in a randomized study of 99 healthy subjects given nightly doses of ramelteon 16 mg or placebo for 28 days Tolbert et al e.
Relative to baseline values, there were no significant changes in any of the 12 thyroid, reproductive, and adrenal endocrine parameters measured. Potential endocrine effects of longer-term nightly use of ramelteon 16 mg were investigated in a placebo-controlled, 6-month study of chronic insomnia subjects Richardson et al c.
Among the 12 parameters evaluated, there were no significant changes in the thyroid and adrenal axes. Gonadotropins and testosterone were unchanged. Relative to baseline, there was an elevation of the mean serum prolactin level observed only in women.
The mean prolactin values remained in the normal reference range and the effect appeared to be transient. There were no apparent associated physical changes. The placebo and ramelteon groups had similar subject-reported menstrual patterns. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ramelteon pronounced as ram el' tee on. Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow?
What special dietary instructions should I follow? What should I do if I forget a dose? What side effects can this medication cause? What should I know about storage and disposal of this medication? Brand names. Swallow the tablets whole; do not split, chew, or crush them. Other uses for this medicine. What special precautions should I follow? Before taking ramelteon, tell your doctor and pharmacist if you are allergic to ramelteon, any other medications, or any of the ingredients in ramelteon tablets.
Ask your pharmacist or check the Medication Guide for a list of the ingredients. Your doctor will probably tell you not to take ramelteon while you are taking this medication. The scientists behind Rozerem's development explain that by targeting melatonin receptors—which are responsible for the brain's sleep-wake cycle—it may avoid the groggy side effects of sedative drugs, which work by slowing down the central nervous system.
A company representative has compared taking Rozerem to shutting down a computer the right way, whereas using other medications is like pulling the plug so that the reboot process takes longer. Next Page: But does Rozerem work? But in clinical trials Rozerem still caused side effects, such as daytime sleepiness and dizziness, in a small percentage of people. It has also been associated with altered hormonal levels, which may cause sexual side effects. Rozerem has not been studied in patients with sleep apnea or related breathing disorders.
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