Drug interactions- summary-

+ Ramelton-

Alcohol-
Coadmininistration use may produce additive CNS effects

Azole antifungals( ketoconazole, fluconazole )-
When administered with ketoconazole AUC and Cmax of ramelton increased

Fluvoxamine -
Ramelton AUC and Cmax  increased significantly. Do not use remelton in combination with fluvoxamine

Rifampin-
Ramelton and metabolite decreased AUC and Cmax when administered with rifampin.

Insomnia

Most frequent reactions resulting in discontinuation of treatment-

Somnolence 0.6%     nausea  0.3%   headache 0.3%   insomnia 0.3%

Most commonly observed adverse reactions-

CNS-    depression  2%    dizziness 4%   headache 3%    insomnia exacerbated 2%
             somnolence 4%

GI -       diarrhea  2%    daugeusia   2%      nausea   2%

Miscellaneous -      arthalgia  2%     influenze 1%    myalgia 2%   
                                 upper respiratory tract infection 2%

Hypersensitivity to the drug or any component of ramelton formulation

Special Precautions-
Psychiatric /physical disorder-  initiate symptomatic treatment of insomnia only after a careful
evalution of the patient

Hepatic function impairment - do not use ramelton in patients with severe hepatic function impairment

Special risks- advice patients to excercise caution if they consume alcohol in combination with
alcohol

Hazardous tasks-  observe caution while driving or performing tasks requiring alertness

Pregnancy- use ramelton during pregnancy only if required

Lactation- use of ramelton in breast-feeding mothers is not recommended

Children- safety and efficacy of ramelton in children have not been established

Monitoring- for patients with unexplained amenorrhea, galactoohea, decreased libido, or
problems with fertility conside assessment levels and testostrone levels as appropiate
 

Indication-
Insomnia

Dosage-
Recommended dose is 8mg taken within 30 minutes of going to bed.
It is recommended that ramelton not be taken with or immediately after a high fat meal.

1. Advice patients to take ramelton within 30 minutes of going to bed and to confine
   their activites to those necessary to prepare for bed.

2. Advice patients to avoid angaging in hazardous activites eg oerating machinery, driving motor
    vehicles after taking ramelton

3. Advice patients to consult their doctor if they experience any of the following- cessation of
    menses, or galactorrhea in women, decreased libido or problems with fertility

4. Advice patients to excercise caution if they consume alcohol in combination with
    ramelton

It is recommended that ramelton not be taken with or immediately after a high fat meal.

Pregnancy-
Use ramelton during pregnancy only if required

Lactation-
Use of ramelton in breast-feeding mothers is not recommended

Children-
Safety and efficacy of ramelton in children have not been established