Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of ramelteon, once daily
      (QD), taken in combination with Gabapentin for treating insomnia.
    

Detailed description: 
      Approximately 60 to 70 million adults in the United States alone are affected by insomnia.
      Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and
      irritability. Recent epidemiologic research focusing on quality of life has identified
      significant insomnia-related morbidities that relate to work productivity, health care
      utilization, and risk of depression. Insomnia is also associated with diminished work output,
      absenteeism, and greater rates of accidents. gamma-aminobutyric acid is the major inhibitory
      transmitter in the central nervous system and most currently prescribed sleep agents are
      benzodiazepine receptor agonists, which induce sleep by binding to the benzodiazepine
      receptor site of the gamma-aminobutyric acid -A receptor complex. In addition to sleep,
      benzodiazepine receptor agonists can cause a wide range of ancillary effects not directly
      related to sleep, including sedative, anxiolytic, muscle-relaxant, and amnesic effects, and
      have risks of tolerance, dependence, and abuse potential.

      Gabapentin is a novel anti-epileptic drug, which is currently used in subjects with partial
      seizures. Some studies have shown that gabapentin also has an effect on sleep architecture.
      In several studies, which included healthy subjects, epileptic subjects, and subjects with
      restless leg syndrome, the use of gabapentin been shown to prolong slow-wave sleep, increase
      total sleep time and sleep efficiency, and decrease number of awakenings.

      Ramelteon is a melatonin receptor agonist with affinity for the human melatonin receptor
      subtype 1, melatonin receptor subtype 2 and selectivity over the melatonin receptor subtype 3
      receptor. It also demonstrates agonist activity in vitro relative to melatonin in cells
      expressing human melatonin receptor subtype 1 or melatonin receptor subtype 2 receptors. The
      binding of melatonin at these receptors is thought to contribute to maintenance of the
      circadian rhythm underlying the normal sleep-wake cycle.

      The purpose of this trial is to determine if the co-administration of Ramelteon and
      gabapentin may produce increased sleep efficiency through reduction of wake time after
      persistent sleep onset, in addition to the reduction in sleep latency and increase in sleep
      duration. Study participation is anticipated to be about one month.
    

Intervention name(s): Ramelteon and gabapentin; Ramelteon and gabapentin; Ramelteon; Gabapentin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ramelteon 4 mg, tablets, orally, once daily and gabapentin 400 mg, capsules, orally, once daily for up to one week.; Ramelteon 8 mg, tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.; Ramelteon 8 mg, tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.; Ramelteon placebo-matching tablets, orally, once daily and gabapentin 800 mg, capsules, orally, once daily for up to one week.; Ramelteon placebo-matching tablets, orally, once daily and gabapentin placebo-matching capsules, orally, once daily for up to one week.
Other intervention name(s): TAK-375; Ramelteon; Neurontin®; Rozerem; TAK-375; Ramelteon; Neurontin®; Rozerem; TAK-375; Rozerem; Neurontin®; Rozerem; Rozerem
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Insomnia; DIMS (Disorders of Initiating and Maintaining Sleep); Disorders of Initiating and Maintaining Sleep; Insomnia Disorder Sleep Initiation Dysfunction; Transient Insomnia; Drug Therapy; Sleep Disorders, Intrinsic