Rozerem Side Effects
Generic name: ramelteon
Generic Name: Ramelteon
Please note - some side effects for Rozerem may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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Side Effects of Rozerem - for the consumer
Rozerem
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rozerem:
Seek medical attention right away if any of these SEVERE side effects occur when using Rozerem:Diarrhea; dizziness; drowsiness; fatigue; nausea; tiredness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; unusual hoarseness); absence of a menstrual cycle; decreased sex drive; difficulty swallowing or breathing; fever; hallucinations; headache; irregular heartbeat; memory problems; mental or mood changes (eg, abnormal thinking, agitation, anxiety, behavior changes, new or worsening depression); muscle aches; muscle or joint pain; pounding in the chest; problems with fertility; shortness of breath; suicidal thoughts or behaviors; unexplained breast milk production; vision changes; vomiting; worsening of sleeplessness.
For the professional
Rozerem
Overview
The data described in this section reflect exposure to Rozerem in 4251 subjects, including 346 exposed for 6 months or longer, and 473 subjects for one year.
Adverse Reactions Resulting in Discontinuation of Treatment
Six percent of the 3594 individual subjects exposed to Rozerem in clinical studies discontinued treatment owing to an adverse event, compared with 2% of the 1370 subjects receiving placebo. The most frequent adverse events leading to discontinuation in subjects receiving Rozerem were somnolence (0.8%), dizziness (0.5%), nausea (0.3%), fatigue (0.3%), headache (0.3%), and insomnia (0.3%).
Rozerem Most Commonly Observed Adverse Events in Phase 1-3 trials
Table 1 displays the incidence of adverse events during the Phase 1 through 3 trials.
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.
| MedDRA Preferred Term | Placebo (n=1370) | Ramelteon 8 mg (n=1250) |
| Headache NOS | 7% | 7% |
| Somnolence | 3% | 5% |
| Fatigue | 2% | 4% |
| Dizziness | 3% | 5% |
| Nausea | 2% | 3% |
| Insomnia exacerbated | 2% | 3% |
| Upper respiratory tract infection NOS | 2% | 3% |
| Diarrhea NOS | 2% | 2% |
| Myalgia | 1% | 2% |
| Depression | 1% | 2% |
| Dysgeusia | 1% | 2% |
| Arthralgia | 1% | 2% |
| Influenza | 0 | 1% |
| Blood cortisol decreased | 0 | 1% |
By body system
Gastrointestinal side effects
Gastrointestinal side effects for ramelteon in relation to placebo therapy have included nausea (3% vs. 2%), diarrhea (2% vs. 2%), and dysgeusia (2% vs. 1%).
Musculoskeletal side effects
Musculoskeletal side effects for ramelteon compared to placebo therapy have included myalgia (2% vs. 1%) and arthralgia (2% vs. 1%).
Nervous system side effects
Nervous system side effects for ramelteon compared to placebo therapy have included somnolence (5% vs. 3%), dizziness (5% vs. 3%), and exacerbated insomnia (3% vs. 2%).
Other side effects
Other side effects for ramelteon compared to placebo therapy have included headache (7% vs. 7%), fatigue (4% vs. 2%) and influenza (1% vs. 0%).
Psychiatric side effects
Psychiatric side effects for ramelteon 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.
Respiratory side effects
Respiratory side effects for ramelteon compared to placebo therapy have included upper respiratory tract infection (3% vs. 2%). Pharyngolaryngeal pain (1.9%) has also been reported.
Endocrine side effects
Endocrine side effects for ramelteon 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.
General side effects
In general, ramelteon 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.
TopMore resources:
Rozerem - Includes detailed dosage instructions.
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