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Ramelteon Dosage

Medically reviewed by Drugs.com. Last updated on Mar 10, 2023.

Applies to the following strengths: 8 mg

Usual Adult Dose for Insomnia

8 mg orally within 30 minutes of going to bed

Maximum Dose: 8 mg per day

Comments: This drug should not be taken with or immediately after a high-fat meal.

Use: Treatment of insomnia characterized by difficulty with sleep onset

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

  • Mild Hepatic Impairment (Child-Pugh A): Data not available.
  • Moderate Hepatic Impairment (Child-Pugh B): Use with caution.
  • Severe Hepatic Impairment (Child-Pugh C): Not recommended.

Dose Adjustments

  • Concomitant Use of CYP450 1A2 Inhibiting Drugs: Contraindicated with fluvoxamine; Caution recommended if used with other CYP450 1A2 inhibitors.

  • Patients with Severe Sleep Apnea: Not recommended.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

  • Hemodialysis: No adjustment recommended.
  • Peritoneal dialysis: Data not available.

Other Comments

Administration Advice:

  • The drug tablet should be swallowed whole; tablets should not be broken.

Storage Requirements:
  • The container should be kept tightly closed to protect from moisture and humidity.

General:
  • This drug does not appear to produce physical dependence; treatment discontinuation after chronic administration did not produce withdrawal signs in humans or in animals.
  • If overdosage occurs, general symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate and IV fluids as needed.

Patient Advice:
  • Do not drink alcohol while taking this drug.
  • Do not take other medications that can make you sleepy while taking this drug.
  • Do not take this drug with food or right after a meal.
  • Do not take this drug unless you are able to get a full night's sleep before you must be active again.
  • After taking this drug, avoid driving and other activities that require concentration such as operating machinery; limit your activities to those necessary to prepare for bed.
  • Consult your healthcare provider if your insomnia worsens or is not better within 7 to 10 days.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.