From the Guidelines
Ramelteon is generally well-tolerated in elderly patients, with a favorable safety profile compared to other sleep medications, and can be used at a dose of 8 mg taken within 30 minutes before bedtime, with monitoring for effectiveness and side effects. The most common adverse effects associated with ramelteon in elderly patients include dizziness, fatigue, somnolence, and headache, which are typically mild and transient 1. Unlike benzodiazepines and non-benzodiazepine hypnotics, ramelteon does not cause significant next-day impairment, respiratory depression, or increased fall risk, making it particularly suitable for elderly patients 1. However, elderly patients may experience altered drug metabolism due to age-related changes in liver function, potentially leading to higher blood levels and increased sensitivity to side effects 1. Ramelteon can interact with fluvoxamine and other CYP1A2 inhibitors, substantially increasing ramelteon levels, and should be used cautiously in patients with severe hepatic impairment and is contraindicated in those with severe sleep apnea or severe COPD 1.
Some key points to consider when prescribing ramelteon to elderly patients include:
- Starting with the standard dose of 8 mg taken within 30 minutes before bedtime
- Monitoring for effectiveness and side effects
- Adjusting treatment as needed
- Being aware of potential interactions with other medications, such as fluvoxamine and other CYP1A2 inhibitors
- Using caution in patients with severe hepatic impairment and contraindicating in those with severe sleep apnea or severe COPD 1.
It is also important to note that while ramelteon is generally well-tolerated, it can cause some adverse effects, and patients should be monitored closely for any signs of adverse effects, such as dizziness, fatigue, somnolence, and headache 1.
From the FDA Drug Label
The most frequent adverse events leading to discontinuation in subjects receiving ramelteon were somnolence, dizziness, nausea, fatigue, headache, and insomnia; all of which occurred in 1% of the patients or less Table 1 displays the incidence of adverse events reported by the 2,861 patients with chronic insomnia who participated in placebo-controlled trials of ramelteon Table 1 Incidence (% of subjects) of Treatment-Emergent Adverse Events MedDRA Preferred Term Placebo (n=1,456) Ramelteon 8 mg (n=1,405) Somnolence 2% 3% Fatigue 2% 3% Dizziness 3% 4% Nausea 2% 3% Insomnia exacerbated 2% 3% The adverse effects of ramelteon in the elderly include:
- Somnolence: 3% of patients
- Fatigue: 3% of patients
- Dizziness: 4% of patients
- Nausea: 3% of patients
- Insomnia exacerbated: 3% of patients These adverse events occurred in 1% of patients or less, leading to discontinuation of treatment 2.
From the Research
Adverse Effects of Ramelteon in Elderly
- The most common adverse events observed with ramelteon included headache (7%), dizziness (5%), somnolence (5%), fatigue (4%), and nausea (3%) 3.
- In elderly patients, ramelteon was generally well tolerated, with no evidence of cognitive impairment, rebound insomnia, withdrawal effects, or abuse potential 3, 4.
- The overall incidence of adverse effects with ramelteon was similar to that of placebo 4.
- Ramelteon has been shown to have no abuse liability and therefore is not scheduled by the U.S. Drug Enforcement Agency as a controlled substance 5.
- Current data on the acute and next-morning effects of ramelteon did not indicate cognitive or psychomotor impairment 6.
Specific Considerations for Elderly Patients
- In elderly patients with primary insomnia, significant reductions in subjective latency to persistent sleep were observed with ramelteon 4 and 8 mg 3.
- Mean reported total sleep time was significantly increased in the 4-mg group 3.
- Ramelteon use in elderly patients with delirium may be associated with statistically significant reduction of PRN antipsychotic use for agitation 7.