Ramelteon Side Effects

Some side effects of ramelteon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ramelteon: oral tablet

Along with its needed effects, ramelteon may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects of ramelteon may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dizziness
  • sleepiness or unusual drowsiness
Less common
  • Body aches or pain
  • change in taste
  • chills
  • cough
  • difficulty in breathing
  • difficulty in moving
  • discouragement
  • ear congestion
  • fatigue
  • feeling sad or empty
  • fever
  • general feeling of discomfort or illness
  • irritability
  • 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
  • nausea
  • pain in joints
  • runny nose
  • shivering
  • sleeplessness
  • sneezing
  • sore throat
  • sweating
  • swollen joints
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • unusual tiredness or weakness
  • vomiting

For Healthcare Professionals

Applies to ramelteon: oral tablet

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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