Amitriptyline Should NOT Be Prescribed for Pediatric Bruxism
Amitriptyline is contraindicated in pediatric patients and should not be prescribed for children with bruxism. The FDA explicitly states that amitriptyline is not approved for use in pediatric patients, and carries a black box warning regarding increased suicidality risk in children and adolescents 1. Additionally, there is no evidence supporting its efficacy for bruxism treatment in any age group.
Critical Safety Concerns in Pediatric Patients
FDA Black Box Warning
- Amitriptyline carries a black box warning specifically cautioning against pediatric use due to increased risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric conditions 1.
- The FDA label explicitly states: "Amitriptyline hydrochloride is not approved for use in pediatric patients" 1.
High Lethality Risk
- The American Academy of Child and Adolescent Psychiatry recommends that tricyclic antidepressants should never be prescribed as first-line treatment for children and adolescents due to their potentially lethal nature 2.
- TCAs have a fatal toxicity index 5 to 8 times higher than newer antidepressants, with a hazard index of 13.8 compared to SSRIs at 0.5 3.
- The small difference between therapeutic and toxic levels makes accidental or intentional overdose particularly dangerous 2.
Lack of Evidence for Bruxism Treatment
No Efficacy Data
- A systematic review of bruxism treatments found no difference in pain or bruxism frequency when amitriptyline was compared to placebo 4.
- There is no evidence-based data supporting amitriptyline for treating sleep bruxism or awake bruxism in any population 5.
- The 2020 systematic review concluded there is insufficient evidence to recommend drug therapy, including amitriptyline, for bruxism management 4.
Paradoxical Risk
- While amitriptyline is mentioned in fibromyalgia guidelines (a different condition), SSRIs—not tricyclics—are actually known to induce or worsen bruxism 6, 7.
- This raises concerns that other antidepressants, including tricyclics, may similarly affect bruxism through serotonergic mechanisms 7.
Evidence-Based Alternatives for Pediatric Bruxism
Supported Treatment Options
- Occlusal splints combined with muscle massage showed benefit in pain reduction related to bruxism 4.
- Botulinum toxin type A (BTX-A) demonstrated significant pain and sleep bruxism frequency reduction compared to placebo at 6 and 12 months 4.
- Behavioral therapy and lifestyle modifications should be first-line approaches 4.
What Does NOT Work
- Biofeedback therapy showed no difference compared to inactive control groups 4.
- Drug therapies including amitriptyline, bromocriptine, clonidine, propranolol, and levodopa showed no difference compared to placebo 4.
Clinical Bottom Line
Never prescribe amitriptyline to children for bruxism. The combination of FDA contraindication, black box warning for suicidality, high lethality in overdose, lack of proven efficacy for bruxism, and availability of safer alternatives makes this an unacceptable choice 2, 1, 4. Focus instead on behavioral interventions, occlusal splints with massage, or consider BTX-A in severe cases refractory to conservative management 4.