Ramelteon Side Effects

Brand Names: Rozerem

Please note - some side effects for Ramelteon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Ramelteon - for the Consumer

Ramelteon

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 Ramelteon:

Diarrhea; dizziness; drowsiness; fatigue; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the hands, legs, mouth, face, lips, eyes, throat, or tongue; unusual hoarseness); absence of a menstrual cycle; decreased sexual desire; hallucinations; headache; memory problems; mental or mood changes (eg, abnormal thinking, agitation, anxiety, behavior changes, new or worsening depression); missed or irregular menstrual period; nausea; nightmares; nipple discharge; problems with fertility; shortness of breath; suicidal thoughts or behaviors; vomiting; worsening of sleeplessness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

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

Musculoskeletal side effects for ramelteon compared to placebo therapy have included myalgia (2% vs. 1%) and arthralgia (2% vs. 1%).

Nervous system

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

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

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.

Discontinuation of ramelteon should be strongly considered for patients who report any complex sleep behavior.

Respiratory

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

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

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.

Hypersensitivity

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.

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 should not be rechallenged with the drug.

Oncologic

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 was also reported to be clastogenic in the in vitro chromosomal aberration assay of animal lung cells.

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