Ramelteon — Membership Pricing

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About Ramelteon

Struggling to fall asleep? Ramelteon offers a unique approach to managing insomnia, helping you gently drift off. As a member of TheDrugClub, you don't have to let high prescription costs stand in the way of a good night's rest. Discover how our program can help you save on this important medication.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Ramelteon is approved for (FDA label)

Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14) ] . Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. ( 1 )

Source: Read the full FDA label on DailyMed. Label effective date: September 1, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Ramelteon (FDA label)

Ramelteon tablets are available in an 8 mg strength tablet for oral administration. Ramelteon tablets 8 mg are yellow, round shaped film coated tablets, debossed with "AC 414" on one side and plain on other side. 8 mg tablets. ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 5a3cf917-3569-4fc1-8b81-ffecfd2de005. SPL document ID: 5a7029de-d11d-4321-e063-6394a90adaf3. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Ramelteon (FDA label)

The following serious adverse reactions are discussed in greater detail in other sections: Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions (5.1) ] Abnormal thinking, behavior changes, and complex behaviors [see Warnings and Precautions (5.3) ] CNS effects [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥3% and more common than with placebo) are: somnolence, dizziness, fatigue, nausea, and exacerbated insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adverse Reactions Resulting in Discontinuation of Treatment The data described in this section reflect exposure to ramelteon in 5,373 subjects, including 722 exposed for six months or longer, and 448 subjects for one year.

Source: FDA prescribing information (DailyMed). Set ID: 5a3cf917-3569-4fc1-8b81-ffecfd2de005. SPL document ID: 5a7029de-d11d-4321-e063-6394a90adaf3. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Ramelteon (FDA label)

Patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. Patients should not take ramelteon tablets in conjunction with fluvoxamine [see Drug Interactions (7) ] . History of angioedema while taking ramelteon. ( 4 ) Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and should not be used in combination. ( 7.1 )

Source: FDA prescribing information (DailyMed). Set ID: 5a3cf917-3569-4fc1-8b81-ffecfd2de005. SPL document ID: 5a7029de-d11d-4321-e063-6394a90adaf3. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Ramelteon (FDA label)

Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ( 5.1 ) Need to evaluate for comorbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment. ( 5.2 ) Abnormal thinking, behavioral changes, complex behaviors: May include "sleep-driving" and hallucinations. Immediately evaluate any new onset behavioral changes. ( 5.3 ) Depression: Worsening of depression or suicidal thinking may occur. ( 5.3 ) CNS effects: Potential impairment of activities requiring complete mental alertness such as operating machinery or driving a motor vehicle, after ingesting the drug. ( 5.4 ) Reproductive effects: Include decreased testosterone and increased prolactin levels.

Source: FDA prescribing information (DailyMed). Set ID: 5a3cf917-3569-4fc1-8b81-ffecfd2de005. SPL document ID: 5a7029de-d11d-4321-e063-6394a90adaf3. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Ramelteon (FDA label)

Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon. ( 7.1 ) Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution. ( 7.1 ) Fluconazole (strong CYP2C9 inhibitor): Increases systemic exposure of ramelteon; administer with caution. ( 7.1 ) Donepezil: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with donepezil. ( 7.1 ) Doxepin: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin. ( 7.1 ) Alcohol: Causes additive psychomotor impairment; should not be used in combination. ( 7.2 ) 7.1 Effects of Other Drugs on Ramelteon Fluvoxamine (strong CYP1A2 inhibitor) AUC 0-inf for ramelteon increased approximately 190-fold, and the C max increased approximately 70- fold upon coadministration of fluvoxamine and ramelteon, compared to ramelteon administered alone.

Source: FDA prescribing information (DailyMed). Set ID: 5a3cf917-3569-4fc1-8b81-ffecfd2de005. SPL document ID: 5a7029de-d11d-4321-e063-6394a90adaf3. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.