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Ramelteon Dosage

Applies to the following strength(s): 8 mg

The information at is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Geriatric Dose for:

Additional dosage information:

Usual Adult Dose for Insomnia

8 mg orally once a day, 30 minutes prior to bedtime, as needed for insomnia.

Usual Geriatric Dose for Insomnia

8 mg orally once a day, 30 minutes prior to bedtime, as needed for insomnia.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction: Data not available
Moderate liver dysfunction: Use with caution
Severe liver dysfunction: Use is considered contraindicated in this population.


A careful evaluation of the patient for physical and/or psychiatric disorders which could manifest as insomnia should be performed prior to initiating therapy with ramelteon. These evaluations should be repeated if insomnia appears to worsen, new cognitive or behavioral abnormalities appear, or insomnia fails to resolve after an adequate period of time.

Ramelteon is considered contraindicated in patients with severe hepatic dysfunction, severe sleep apnea, and severe chronic obstructive pulmonary disease (COPD).

Ramelteon should not be used concomitantly with fluvoxamine. Caution should be used when administering ramelteon concomitantly with drugs which inhibit the CYP450 1A2 enzyme.

Ramelteon should be used with caution in patients who are primarily depressed since the use of hypnotic agents, including ramelteon, have been associated with a worsening of depression, including suicidal ideation, in this patient population.

Ramelteon may impair the mental abilities necessary for potentially hazardous tasks such as driving or operating machinery. After taking ramelteon, patients should be advised to limit activities to those necessary to prepare for bed.

Ramelteon has been associated with decreased testosterone and increased prolactin levels. Instruct patients to notify their clinician if they experience cessation of menses, galactorrhea, decreased libido, or fertility problems. In these patients, assessment of prolactin and testosterone levels is considered appropriate.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age). In addition, there are no data on the effect, if any, that ramelteon may have on the reproductive axis of developing humans when administered on a chronic or chronic intermittent schedule.


Hemodialysis: no adjustment recommended
Peritoneal dialysis: data not available

Other Comments

Ramelteon should not be consumed with or immediately after a high fat meal.