Rozerem

Rozerem, a prescription medicine, is licensed to treat insomnia for people who have difficulty falling asleep. The sleep medication, which works by stimulating melatonin receptors in the body, is not a controlled substance and is not habit-forming. Rozerem comes in the form of a tablet and is only available in an 8 mg strength. Potential side effects may include drowsiness, fatigue, and dizziness.

 

What Is Rozerem?

Rozerem® (ramelteon) is a prescription sleep medication that has been licensed as an insomnia treatment for people with difficulty falling asleep.
 
(Click Rozerem Uses for more information, including possible off-label uses.)
 

Who Makes Rozerem?

The drug is manufactured by Takeda Pharmaceuticals.
 

How Does It Work?

Rozerem works by stimulating melatonin receptors in the body. This helps people to fall asleep. Unlike many other insomnia medications, it is not habit-forming and is not a controlled substance.
 

Effectiveness

The medication has been evaluated in several clinical studies for insomnia. In studies of Rozerem for chronic insomnia, people who took it fell asleep faster than people who did not take it. Similar results were seen in a study in people with transient insomnia (insomnia that comes and goes).
 
Studies have shown that it does not cause a "hangover" effect in the morning and does not cause rebound insomnia (worsening of insomnia after stopping a medication).
 

When and How Do I Take Rozerem?

Some general considerations for when and how to take the medication include:
 
  • Rozerem comes in tablet form and is taken once a day, 30 minutes before bedtime.
     
  • It is recommended that you take your dose with a glass of water, not after a meal, and not with food.
     
  • It works quickly; make sure that you are ready for sleep before taking it. Do not take the medication before driving or performing any tasks that require concentration.
     
  • For it to work properly, you have to take it as prescribed. It will not work if you take it differently than how your healthcare provider has prescribed.
     

Dosing

There is only one recommended dosage of this medication -- Rozerem 8 mg.
 
(Click Rozerem Dosing for more information.)
 

Side Effects

As with any medicine, there are possible side effects. However, not everyone who takes the drug will experience side effects. In fact, most people tolerate it well. When side effects do occur, in most cases they are minor, meaning they require no treatment or are easily treated by you or your healthcare provider.
 
The most common side effects include:
 
  • Drowsiness
  • Fatigue
  • Dizziness.
     
(Click Side Effects of Rozerem to learn more about specific side effects, including serious side effects to look out for.)
 
You can also read about other possible side effects by clicking on the following eMedTV links:
 

Drug Interactions With Rozerem

Rozerem can potentially interact with a number of medications.
 
(Click Rozerem Interactions for more information about potential drug interactions.)
 

What Should I Tell My Healthcare Provider?

Prior to taking this medication, you should notify your healthcare provider if you have:
 
Also, let your healthcare provider know if you:
 
  • Are pregnant or thinking about becoming pregnant (see Rozerem and Pregnancy)
  • Are breastfeeding
  • Drink alcohol.
     
Also, tell your healthcare provider about all other medicines you may also be taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.
 
(Click Rozerem Warnings and Precautions for more information on this topic, including information on who should not take it.)
 

Overdose 

In studies, large doses of Rozerem did not cause any problems. However, the number of people who have taken large doses of the drug is very small; therefore, the exact effects of an overdose are not known.
 
(Click Rozerem Overdose for more information.)
 

What Should I Do If I Miss a Dose?

Rozerem is meant to be taken only before bedtime. Do not make up for any missed doses, and do not take it during the day or in the middle of the night.
 

Storage Methods

The medication should be stored at room temperature, away from moisture or heat. Rozerem tablets should be kept in an airtight container.
 
Keep this medication and all other medications out of the reach of children.
 

Strengths of Rozerem

There is only one strength available -- Rozerem 8 mg.
 

Generic Rozerem

There is currently no generic Rozerem available for sale.
 
(Click Generic Rozerem for more information.)
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;