Ramelteon

Ramelteon is a prescription medicine used to treat the symptoms of insomnia.

• Ramelteon is available under the following different brand names: Rozerem

Adult dosage

Tablet

• 8mg

Insomnia

Adult dosage

• 8 mg orally every night at bedtime

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ramelteon include:

• drowsiness,
• tired feeling,
• dizziness,
• nausea, and
• worsening sleep problems.

Serious side effects of Ramelteon include:

• unusual thoughts or behavior,
• hallucinations,
• worsening depression,
• thoughts about hurting yourself,
• missed menstrual periods,
• nipple discharge, and
• loss of interest in sex.

Rare side effects of Ramelteon include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Ramelteon has severe interactions with the following drugs:
  • calcium/magnesium/potassium/sodium oxybates
  • fluvoxamine
  • sodium oxybate
• Ramelteon has serious interactions with the following drugs:
  • abametapir
  • benzhydrocodone/acetaminophen
  • fentanyl
  • fentanyl intranasal
  • fentanyl transdermal
  • fentanyl transmucosal
  • givosiran
  • hydrocodone
  • lemborexant
  • metoclopramide intranasal
  • oxycodone
  • pefloxacin
  • selinexor
  • sufentanil SL
  • valerian
• Ramelteon has moderate interactions with at least 188 other drugs.
• Ramelteon has minor interactions with at least 63 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• History of angioedema with previous therapy
• Concomitant fluvoxamine

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ramelteon?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ramelteon?”

Cautions

• Angioedema and anaphylaxis reported; do not rechallenge if such reactions occur
• Reevaluate if insomnia persists after 7-10 days of treatment
• Abnormal thinking, behavioral changes, complex behaviors, including “sleep-driving” and hallucinations; immediately evaluate any new onset of behavioral changes
• Worsening of depression or suicidal thinking may occur
• May impair activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug
• Endocrine effects include decreased testosterone and increased prolactin levels; effect on reproductive axis in developing humans unknown
• Use caution in patients with respiratory compromise, including sleep apnea or COPD; not recommended in patients with severe sleep apnea
• Use caution in patients with hepatic impairment; not recommended in severe hepatic impairment
• Review drug interactions database for significant drug interactions

Pregnancy and Lactation

Available data from postmarketing reports with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Lactation

• There are no data regarding the presence of drugs or metabolites in human milk, effects on the breastfed infant, or milk production
• The drug and/or its metabolites are present in rat milk; when a drug is present in animal milk, the drug will likely be present in human milk; because of the mechanism of action of the drug, there is a potential risk for somnolence in a breastfed infant; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on the breastfed infant from the drug or underlying maternal condition
• Infants exposed to the drug through breastmilk should be monitored for somnolence and feeding problems; a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 25 hours (approximately 5 elimination half-lives) after drug administration to minimize drug exposure to a breastfed infant