Ramelteon

DEA Class;  Rx

Common Brand Names; Rozerem

Hypersensitivity

History of angioedema with previous therapy

Concomitant fluvoxamine

Dizziness

Somnolence (similar to placebo)

Fatigue

Headache

Dysgeusia

Nausea

Depression

Worsening of insomnia

Hallucinations

Mania

Angioedema (rare )

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

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

There are no data regarding presence of drug or metabolites in human milk, effects on breastfed infant, or on milk production