Does Rozerem (ramelteon) cause side effects?
Melatonin and its receptors control the circadian rhythm of the body which controls the sleep/wake cycle. Unlike many drugs used for treating insomnia, Rozerem is not addictive, and it is not a controlled substance. Rozerem also does not cause withdrawal symptoms or rebound insomnia when it is stopped.
Common side effects of Rozerem include
Serious side effects of Rozerem include
- abnormal thinking,
- behavior changes,
- suicidal thoughts,
- manic episodes,
- sleep-driving, and
- rare severe allergic reactions involving swelling of the tongue and closure of the throat.
Rifampin may decrease blood levels of Rozerem, possibly reducing the effect of Rozerem.
Alcohol increases the sedative effects Rozerem.
Rozerem has not been evaluated in pregnant women. Rozerem should not be used in pregnant women unless it is absolutely necessary. Rozerem has not been evaluated in nursing mothers. Consult your doctor before breastfeeding.
What are the important side effects of Rozerem (ramelteon)?
Side effects associated with ramelteon include:
Rare cases of severe allergic reactions involving swelling of the tongue and closure of the throat have been reported.
Other important side effects include:
Rozerem (ramelteon) side effects list for healthcare professionals
The following serious adverse reactions are discussed in greater detail in other sections:
- Severe anaphylactic and anaphylactoid reactions
- Abnormal thinking, behavior changes, and complex behaviors
- CNS effects
Clinical Trials Experience
Adverse Reactions Resulting In Discontinuation Of Treatment
The data described in this section reflect exposure to Rozerem in 5373 subjects, including 722 exposed for six months or longer, and 448 subjects for one year.
Six percent of the 5373 individual subjects exposed to Rozerem in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 2279 subjects receiving placebo.
The most frequent adverse events leading to discontinuation in subjects receiving Rozerem were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less.
Rozerem Most Commonly Observed Adverse Events
Table 1 displays the incidence of adverse events reported by the 2861 patients with chronic insomnia who participated in placebo-controlled trials of Rozerem.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of other drugs, and may not reflect the rates observed in practice.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Table 1. Incidence (% of subjects) of Treatment-Emergent Adverse Events
|MedDRA Preferred Term||Placebo|
|Ramelteon 8 mg|
What drugs interact with Rozerem (ramelteon)?
Effects Of Other Drugs On Rozerem
Fluvoxamine (Strong CYP1A2 Inhibitor)
AUC0-inf for ramelteon increased approximately 190-fold, and the Cmax increased approximately 70- fold upon coadministration of fluvoxamine and Rozerem, compared to Rozerem administered alone. Rozerem should not be used in combination with fluvoxamine. Other less strong CYP1A2 inhibitors have not been adequately studied. Rozerem should be administered with caution to patients taking less strong CYP1A2 inhibitors.
Rifampin (Strong CYP Enzyme Inducer)
Administration of multiple doses of rifampin resulted in a mean decrease of approximately 80% in total exposure to ramelteon and metabolite M-II. Efficacy may be reduced when Rozerem is used in combination with strong CYP enzyme inducers such as rifampin.
Ketoconazole (Strong CYP3A4 Inhibitor)
The AUC0-inf and Cmax of ramelteon increased by approximately 84% and 36% upon coadministration of ketoconazole with Rozerem. Rozerem should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole.
Fluconazole (Strong CYP2C9 Inhibitor)
The AUC0-inf and Cmax of ramelteon was increased by approximately 150% when Rozerem was coadministered with fluconazole. Rozerem should be administered with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole.
The AUC0-inf and Cmax of ramelteon increased by approximately 100% and 87%, respectively upon coadministration of donepezil with Rozerem. Patients should be closely monitored when Rozerem is coadministered with donepezil.
The AUC0-inf and Cmax of ramelteon increased by approximately 66% and 69%, respectively, upon coadministration of doxepin with Rozerem. Patients should be closely monitored when Rozerem is coadministered with doxepin.
Effect Of Alcohol On Rozerem
Alcohol by itself impairs performance and can cause sleepiness. Since the intended effect of Rozerem is to promote sleep, patients should be cautioned not to consume alcohol when using Rozerem. Use of the products in combination may have an additive effect.
Drug/Laboratory Test Interactions
Rozerem is not known to interfere with commonly used clinical laboratory tests. In addition, in vitro data indicate that ramelteon does not cause false-positive results for benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screening methods in vitro.
Does Rozerem (ramelteon) cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
Rozerem is not a controlled substance.
Discontinuation of ramelteon in animals or in humans after chronic administration did not produce withdrawal signs. Ramelteon does not appear to produce physical dependence.
A laboratory abuse potential study was performed with Rozerem.
Ramelteon did not produce any signals from animal behavioral studies indicating that the drug produces rewarding effects. Monkeys did not self-administer ramelteon and the drug did not induce a conditioned place preference in rats.
There was no generalization between ramelteon and midazolam. Ramelteon did not affect rotorod performance, an indicator of disruption of motor function, and it did not potentiate the ability of diazepam to interfere with rotorod performance.
Rozerem (ramelteon) is a hypnotic type of sedative that promotes falling asleep used to treat insomnia. It acts by stimulating receptors for melatonin in the brain. Common side effects of Rozerem include headache, drowsiness, fatigue, dizziness, nausea, worsening of insomnia, and diarrhea. Rozerem should not be used in pregnant women unless it is absolutely necessary. Rozerem has not been evaluated in nursing mothers. Consult your doctor before breastfeeding.
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Related Disease Conditions
A number of vital tasks carried out during sleep help maintain good health and enable people to function at their best. Sleep needs vary from individual to individual and change throughout your life. The National Institutes of Health recommend about 7-9 hours of sleep each night for older, school-aged children, teens, and most average adults; 10-12 for preschool-aged children; and 16-18 hours for newborns. There are two stages of sleep: 1) REM sleep (rapid-eye movement), and 2) NREM sleep (non-rapid-eye movement).
Insomnia is the perception or complaint of inadequate or poor-quality sleep because of difficulty falling asleep; waking up frequently during the night with difficulty returning to sleep; waking up too early in the morning; or unrefreshing sleep. Secondary insomnia is the most common type of insomnia. Treatment for insomnia include lifestyle changes, cognitive behavioral therapy, and medication.
Sleep Disorders in Children and Teenagers
Sleep needs in children and teenagers depend on the age of the child. Sleep disorders in children such as: sleep apnea, parasomnias, confusional arousals, night terrors, nightmares, narcolepsy, and sleepwalking which can affect a child's or teen's sleep. Healthy sleep habits and good sleep hygiene can help your infant, toddler, preschooler, tween, or teenager get a good night's sleep.
Insomnia Treatment (Sleep Aids and Stimulants)
Insomnia is difficulty in falling or staying asleep, the absence of restful sleep, or poor quality of sleep. Insomnia is a symptom and not a disease. The most common causes of insomnia are medications, psychological conditions, environmental changes, and stressful events. Treatments may include non-drug treatments, over-the-counter medicines, and/or prescription medications.
What Causes Insomnia?
Insomnia is defined as repeated difficulty with sleep initiation, maintenance, consolidation, or quality that occurs despite adequate time and opportunity for sleep and results in some form of daytime impairment. There are three types of insomnia.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects, drug interactions, and addiction sections courtesy of the U.S. Food and Drug Administration.