What are the common side effects of Lunesta (eszopiclone)?

Common Side Effects of Lunesta (Eszopiclone)

The most common side effects of Lunesta are unpleasant/bitter taste in the mouth, drowsiness, dizziness, headache, dry mouth, and symptoms of the common cold. 1

Most Frequent Side Effects

Taste Disturbances (Most Characteristic)

• Unpleasant or bitter/metallic taste is the hallmark side effect of eszopiclone, occurring in approximately 7-26% of patients compared to 0.5-5.6% with placebo 2
• This taste disturbance is dose-related, with higher incidence at the 3 mg dose 2
• While bothersome, this side effect is generally not serious enough to preclude use in appropriate patients 2

Common Non-Serious Side Effects

• Drowsiness - may persist into the next day, affecting driving ability and cognitive function 1
• Dizziness 1, 3
• Headache 1, 4, 3
• Dry mouth 1
• Symptoms of the common cold 1
• Dyspepsia, pain, and diarrhea 4
• Upper respiratory tract infection and urinary tract infection 4

Serious Side Effects (Less Common but Important)

Complex Sleep Behaviors

• Getting out of bed while not fully awake and performing activities unconsciously, including sleep-walking, sleep-eating, sleep-talking, sleep-driving, and having sex while asleep 1
• These behaviors warrant immediate discontinuation and contact with healthcare provider 1

Cognitive and Psychiatric Effects

• Abnormal thoughts and behavior: more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations 1
• Worsening of depression and suicidal thoughts or actions 1
• Memory loss 1
• Anxiety 1

Severe Allergic Reactions

• Swelling of tongue or throat, trouble breathing, nausea and vomiting - require emergency medical attention 1

Long-Term and Observational Safety Concerns

Serious Harms from Observational Data

• Eszopiclone is associated with mild to moderate adverse effects in observational studies, which is more favorable than zolpidem's profile of serious adverse effects (amnesia, vertigo, confusion, diplopia) 5
• Increased infection incidence has been reported with eszopiclone in pooled RCT data 5
• In older patients, sedative-hypnotics including eszopiclone show increased risks of:
  • 5-fold increase in memory loss, confusion, and disorientation 5
  • 3-fold increase in dizziness, loss of balance, or falls 5
  • 4-fold increase in residual morning sedation 5

Potential for Dependence

• Eszopiclone is a federally controlled substance (C-IV) due to abuse and dependence potential 1
• Tolerance did not occur during 12-month administration in clinical trials 4
• Withdrawal symptoms including anxiety, abnormal dreams, hyperesthesia, nausea, and upset stomach have been reported following discontinuation 4

Critical Clinical Caveats

Next-Day Impairment

• Patients may still feel drowsy the next day and should not drive or perform dangerous activities until fully awake 1
• FDA warns that drugs taken at bedtime remain at levels high enough to interfere with morning driving 5

Dosing Considerations

• Lower doses (1-2 mg) are recommended for elderly patients (≥65 years) due to prolonged elimination half-life 4
• Dose reduction is advised in women and older/debilitated adults 5