Rozerem Side Effects
Generic Name: ramelteon
Note: This page contains side effects data for the generic drug ramelteon. It is possible that some of the dosage forms included below may not apply to the brand name Rozerem.
It is possible that some side effects of Rozerem may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to ramelteon: oral tablet
As well as its needed effects, ramelteon (the active ingredient contained in Rozerem) may cause unwanted side effects that require medical attention.
Some ramelteon side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common
- sleepiness or unusual drowsiness
- Body aches or pain
- change in taste
- difficulty in breathing
- difficulty in moving
- ear congestion
- feeling sad or empty
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- loss of interest or pleasure
- loss of taste
- loss of voice
- muscle aching or cramping
- muscle pain or stiffness
- nasal congestion
- pain in joints
- runny nose
- sore throat
- swollen joints
- trouble concentrating
- trouble sleeping
- unable to sleep
- unusual tiredness or weakness
For Healthcare Professionals
Applies to ramelteon: oral tablet
Gastrointestinal side effects for ramelteon (the active ingredient contained in Rozerem) in relation to placebo therapy have included nausea (3% vs. 2%), diarrhea (2% vs. 2%), and dysgeusia (2% vs. 1%).[Ref]
Musculoskeletal side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included myalgia (2% vs. 1%) and arthralgia (2% vs. 1%).[Ref]
Nervous system side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included somnolence (5% vs. 3%), dizziness (5% vs. 3%), and exacerbated insomnia (3% vs. 2%).[Ref]
Other side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included headache (7% vs. 7%), fatigue (4% vs. 2%) and influenza (1% vs. 0%).[Ref]
Psychiatric side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included depression (2% vs. 1%). Hallucinations, as well as behavioral changes such as bizarre behavior, agitation, and mania have also been reported with ramelteon use.
A variety of cognitive and behavior changes have been reported to occur in association with the use of hypnotics. In primarily depressed patients, worsening of depression (including suicidal ideation and completed suicides) has been reported in association with the use of hypnotics.
Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex), with amnesia for the event, have been reported in association with hypnotic use. Complex behaviors have been reported with the use of ramelteon.[Ref]
Discontinuation of ramelteon should be strongly considered for patients who report any complex sleep behavior.[Ref]
Respiratory side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included upper respiratory tract infection (3% vs. 2%). Pharyngolaryngeal pain (1.9%) has also been reported.[Ref]
Endocrine side effects for ramelteon (the active ingredient contained in Rozerem) compared to placebo therapy have included decreased blood cortisol level (1% vs. 0%). Compared with placebo, increases in serum prolactin levels have been reported in patients receiving a 16 mg dose (19% vs 32%, respectively) of ramelteon.[Ref]
In general, ramelteon (the active ingredient contained in Rozerem) has been well tolerated with most side effects described as mild or moderate in severity. In clinical trials, approximately 5% of patients discontinued treatment with ramelteon due to side effects. There have been no reports of cognitive impairment, rebound insomnia following discontinuation of ramelteon, withdrawal effects, or abuse.[Ref]
Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with ramelteon (the active ingredient contained in Rozerem) should not be rechallenged with the drug.
Hypersensitivity side effects including rare cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of ramelteon. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis.
Oncologic side effects reported in animal studies have included dose related increases in the incidence of hepatic tumors (adenomas, carcinomas, hepatoblastomas) and an increased incidence of benign Leydig cell tumors of the testis. Ramelteon (the active ingredient contained in Rozerem) was also reported to be clastogenic in the in vitro chromosomal aberration assay of animal lung cells.[Ref]
1. Borja NL, Daniel KL "Ramelteon for the treatment of insomnia." Clin Ther 28 (2006): 1540-55
2. "Product Information. Rozerem (ramelteon)." Takeda Pharmaceuticals America, Lincolnshire, IL.
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